Clinical Trial Results:
Oxidative stress and Circulating Nuclear DNA (cfDNA) in critically ill patients with acute kidney failure treated with continuous renal replacement therapies.
Effect of two anticoagulation strategies of the extracorporeal purification system in renal function recovery.
Summary
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EudraCT number |
2016-004361-12 |
Trial protocol |
ES |
Global end of trial date |
30 May 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
06 Nov 2024
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First version publication date |
06 Nov 2024
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
FER-CIT-2016-01
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT06646328 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Fernando Sánchez
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Sponsor organisation address |
Carrer de Sanz de Bremond, 8, 1, Castelló de la Plana, Spain, 12004
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Public contact |
Fernando Sánchez, Fernando Sánchez, 34 625978412, sanchez_fermor@gva.es
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Scientific contact |
Fernando Sánchez, Fernando Sánchez, 34 625978412, sanchez_fermor@gva.es
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
01 Oct 2024
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
30 May 2022
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Global end of trial reached? |
Yes
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Global end of trial date |
30 May 2022
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
1. To compare the effect on bio-incompatibility induced oxidative stress and systemic oxidative stress in critically ill patients with ARF using two anticoagulation strategies of the extracorporeal system in continuous renal replacement therapies (CRRT) (heparin vs citrate).
2. To compare the effect on extracellular levels of circulating nucleosomes in critically ill patients with ARF employing two anticoagulation strategies of the extracorporeal system CRRT (heparin vs citrate).
3. To evaluate the clinical impact in terms of recovery of renal function in critically ill patients with ARF when two anticoagulation strategies of the extracorporeal system CRRT (heparin vs citrate) are used.
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Protection of trial subjects |
Patients who are able to provide consent can participate in the study by signing the Informed Consent (IC) form.
If a patient is unable to provide consent, we will seek consent from their family.
If there is no family available, we will consider the opinion of the person the patient trusts or their designated decision-maker.
If none of these options are available, deferred consent will not be considered and the patient will not be included in the study.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
03 Apr 2017
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Spain: 20
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Worldwide total number of subjects |
20
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EEA total number of subjects |
20
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
12
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From 65 to 84 years |
8
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85 years and over |
0
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Recruitment
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Recruitment details |
Inclusion criteria: Adult patients in the intensive care unit with acute kidney injury requiring continuous renal replacement therapy. Patients or their families must sign the Informed Consent (IC) form before randomization to participate in the study. Randomization by sealed envelopes. | |||||||||
Pre-assignment
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Screening details |
Exclusion Criteria: < 18 years old. Pregnancy or lactation. Terminal disease or life expectancy < 48 hours. Increased risk of bleeding. Systemic anticoagulation therapy. Contraindication for heparin. Heparin-induced thrombocytopenia. Dialysis before inclusion. Hypercalcemia. Severe Hepatitis. Cirrhosis. Inclusion in another protocol. | |||||||||
Period 1
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Period 1 title |
T0
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Heparin | |||||||||
Arm description |
Anticoagulation with heparin during continuous renal replacement therapies | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Heparin
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Investigational medicinal product code |
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Other name |
Unfractionated heparin
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Pharmaceutical forms |
Concentrate for solution for haemodialysis
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Routes of administration |
Extracorporeal use
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Dosage and administration details |
Initial dose of 500–1000 IU/hour with adaptation of the infusion to the patient and the clotting time.
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Arm title
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Citrate | |||||||||
Arm description |
Citrate anticoagulation during continuous renal replacement therapies | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Trisodium citrate
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for solution for haemodialysis
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Routes of administration |
Extracorporeal use
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Dosage and administration details |
Regional citrate anticoagulation was used at an initial dose of 4 mmol/L and with a calcium reinfusion solution at an initial dose of 1.7 mmol/L, with adaptation of both infusions to the patient ionic calcium levels.
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Period 2
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Period 2 title |
T1 prefilter (60 minutes)
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Is this the baseline period? |
No | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Heparin | |||||||||
Arm description |
Anticoagulation with heparin during continuous renal replacement therapies | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Heparin
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Investigational medicinal product code |
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Other name |
Unfractionated heparin
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Pharmaceutical forms |
Concentrate for solution for haemodialysis
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Routes of administration |
Extracorporeal use
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Dosage and administration details |
Initial dose of 500–1000 IU/hour with adaptation of the infusion to the patient and the clotting time.
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Arm title
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Citrate | |||||||||
Arm description |
Citrate anticoagulation during continuous renal replacement therapies | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Trisodium citrate
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for solution for haemodialysis
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Routes of administration |
Extracorporeal use
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Dosage and administration details |
Regional citrate anticoagulation was used at an initial dose of 4 mmol/L and with a calcium reinfusion solution at an initial dose of 1.7 mmol/L, with adaptation of both infusions to the patient ionic calcium levels.
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Period 3
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Period 3 title |
T1 postfilter (60 minutes)
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Is this the baseline period? |
No | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Heparin | |||||||||
Arm description |
Anticoagulation with heparin during continuous renal replacement therapies | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Heparin
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Investigational medicinal product code |
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Other name |
Unfractionated heparin
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Pharmaceutical forms |
Concentrate for solution for haemodialysis
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Routes of administration |
Extracorporeal use
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Dosage and administration details |
Initial dose of 500–1000 IU/hour with adaptation of the infusion to the patient and the clotting time.
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Arm title
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Citrate | |||||||||
Arm description |
Citrate anticoagulation during continuous renal replacement therapies | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Trisodium citrate
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for solution for haemodialysis
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Routes of administration |
Extracorporeal use
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Dosage and administration details |
Regional citrate anticoagulation was used at an initial dose of 4 mmol/L and with a calcium reinfusion solution at an initial dose of 1.7 mmol/L, with adaptation of both infusions to the patient ionic calcium levels.
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Period 4
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Period 4 title |
T2 prefilter (24 hours)
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Is this the baseline period? |
No | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Heparin | |||||||||
Arm description |
Anticoagulation with heparin during continuous renal replacement therapies | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Heparin
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Investigational medicinal product code |
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Other name |
Unfractionated heparin
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Pharmaceutical forms |
Concentrate for solution for haemodialysis
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Routes of administration |
Extracorporeal use
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Dosage and administration details |
Initial dose of 500–1000 IU/hour with adaptation of the infusion to the patient and the clotting time.
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Arm title
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Citrate | |||||||||
Arm description |
Citrate anticoagulation during continuous renal replacement therapies | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Trisodium citrate
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for solution for haemodialysis
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Routes of administration |
Extracorporeal use
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Dosage and administration details |
Regional citrate anticoagulation was used at an initial dose of 4 mmol/L and with a calcium reinfusion solution at an initial dose of 1.7 mmol/L, with adaptation of both infusions to the patient ionic calcium levels.
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Notes [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period. Justification: One patient in the heparin arm and two in the citrate arm died between periods 3 and 4. |
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Period 5
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Period 5 title |
T2 postfilter (24 hours)
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Is this the baseline period? |
No | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Heparin | |||||||||
Arm description |
Anticoagulation with heparin during continuous renal replacement therapies | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Heparin
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Investigational medicinal product code |
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Other name |
Unfractionated heparin
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Pharmaceutical forms |
Concentrate for solution for haemodialysis
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Routes of administration |
Extracorporeal use
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Dosage and administration details |
Initial dose of 500–1000 IU/hour with adaptation of the infusion to the patient and the clotting time.
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Arm title
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Citrate | |||||||||
Arm description |
Citrate anticoagulation during continuous renal replacement therapies | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Trisodium citrate
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Investigational medicinal product code |
||||||||||
Other name |
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Pharmaceutical forms |
Concentrate for solution for haemodialysis
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Routes of administration |
Extracorporeal use
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Dosage and administration details |
Regional citrate anticoagulation was used at an initial dose of 4 mmol/L and with a calcium reinfusion solution at an initial dose of 1.7 mmol/L, with adaptation of both infusions to the patient ionic calcium levels.
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Baseline characteristics reporting groups
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Reporting group title |
Heparin
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Reporting group description |
Anticoagulation with heparin during continuous renal replacement therapies | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Citrate
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Reporting group description |
Citrate anticoagulation during continuous renal replacement therapies | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Heparin
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Reporting group description |
Anticoagulation with heparin during continuous renal replacement therapies | ||
Reporting group title |
Citrate
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Reporting group description |
Citrate anticoagulation during continuous renal replacement therapies | ||
Reporting group title |
Heparin
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Reporting group description |
Anticoagulation with heparin during continuous renal replacement therapies | ||
Reporting group title |
Citrate
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Reporting group description |
Citrate anticoagulation during continuous renal replacement therapies | ||
Reporting group title |
Heparin
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Reporting group description |
Anticoagulation with heparin during continuous renal replacement therapies | ||
Reporting group title |
Citrate
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Reporting group description |
Citrate anticoagulation during continuous renal replacement therapies | ||
Reporting group title |
Heparin
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Reporting group description |
Anticoagulation with heparin during continuous renal replacement therapies | ||
Reporting group title |
Citrate
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Reporting group description |
Citrate anticoagulation during continuous renal replacement therapies | ||
Reporting group title |
Heparin
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Reporting group description |
Anticoagulation with heparin during continuous renal replacement therapies | ||
Reporting group title |
Citrate
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Reporting group description |
Citrate anticoagulation during continuous renal replacement therapies |
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End point title |
Recovery of renal function | ||||||||||||
End point description |
Duration of RRT
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End point type |
Primary
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End point timeframe |
Through study completion, an average of 20 days
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Statistical analysis title |
Duration of renal replacement therapy | ||||||||||||
Comparison groups |
Heparin v Citrate
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Number of subjects included in analysis |
20
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [1] | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
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Notes [1] - 0.114 |
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End point title |
Recovery of renal function | ||||||||||||||||||
End point description |
Recovery of renal function and dialysis dependency at ICU discharge
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End point type |
Primary
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End point timeframe |
Through study completion, an average of 20 days
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Statistical analysis title |
Recovery of renal function | ||||||||||||||||||
Comparison groups |
Heparin v Citrate
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Number of subjects included in analysis |
13
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||||
P-value |
< 0.05 [2] | ||||||||||||||||||
Method |
Fisher exact | ||||||||||||||||||
Parameter type |
Risk ratio (RR) | ||||||||||||||||||
Point estimate |
2.333
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Confidence interval |
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level |
95% | ||||||||||||||||||
sides |
2-sided
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lower limit |
0.635 | ||||||||||||||||||
upper limit |
8.569 | ||||||||||||||||||
Notes [2] - 0.286 |
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End point title |
Recovery of renal function | ||||||||||||||||||
End point description |
Recovery of renal function and dialysis dependency at hospital discharge
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End point type |
Primary
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End point timeframe |
Through study completion, an average of 20 days
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Statistical analysis title |
Recovery of renal function | ||||||||||||||||||
Comparison groups |
Heparin v Citrate
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Number of subjects included in analysis |
12
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||||
P-value |
< 0.05 [3] | ||||||||||||||||||
Method |
Fisher exact | ||||||||||||||||||
Parameter type |
Risk ratio (RR) | ||||||||||||||||||
Point estimate |
0.833
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Confidence interval |
|||||||||||||||||||
level |
95% | ||||||||||||||||||
sides |
2-sided
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lower limit |
0.583 | ||||||||||||||||||
upper limit |
1.192 | ||||||||||||||||||
Notes [3] - 1.00 |
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End point title |
Activation and elimination of free radicals | ||||||||||||
End point description |
GSH at the beginning of RRT
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End point type |
Secondary
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End point timeframe |
At the beginning of RRT
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Statistical analysis title |
GSH at the beginning of RRT | ||||||||||||
Comparison groups |
Heparin v Citrate
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Number of subjects included in analysis |
20
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [4] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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Notes [4] - 0.322 |
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End point title |
Activation and elimination of free radicals | ||||||||||||
End point description |
GSH prefilter 60 minutes after initiation of RRT
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End point type |
Secondary
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End point timeframe |
60 minutes after initiation of RRT
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Statistical analysis title |
GSH prefilter 60 minutes after initiation RRT | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
20
|
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Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [5] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
|||||||||||||
Notes [5] - 0.409 |
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|||||||||||||
End point title |
Activation and elimination of free radicals | ||||||||||||
End point description |
GSH postfilter 60 minutes after initiation of RRT
|
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End point type |
Secondary
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||||||||||||
End point timeframe |
60 minutes after initiation of RRT
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||||||||||||
|
|||||||||||||
Statistical analysis title |
GSH postfilter 60 minutes after initiation | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
20
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [6] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Parameter type |
d Cohen | ||||||||||||
Point estimate |
-0.986
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
|
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lower limit |
-1.907 | ||||||||||||
upper limit |
-0.041 | ||||||||||||
Notes [6] - 0.041 |
|
|||||||||||||
End point title |
Activation and elimination of free radicals | ||||||||||||
End point description |
Change in GSH prefilter/postfilter 60 minutes after initiation RRT heparin
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
60 minutes after initiation RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
GSH prefilter/postfilter 60 minutes heparin | ||||||||||||
Comparison groups |
Heparin v Heparin
|
||||||||||||
Number of subjects included in analysis |
20
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [7] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Parameter type |
d Cohen | ||||||||||||
Point estimate |
0.903
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
0.142 | ||||||||||||
upper limit |
1.63 | ||||||||||||
Notes [7] - 0.019 |
|
|||||||||||||
End point title |
Activation and elimination of free radicals | ||||||||||||
End point description |
Change in GSH prefilter/postfilter 60 minutes after initiation RRT citrate
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
60 minutes after initiation RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
GSH prefilter/postfilter 60 minutes citrate | ||||||||||||
Comparison groups |
Citrate v Citrate
|
||||||||||||
Number of subjects included in analysis |
20
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [8] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
|||||||||||||
Notes [8] - 0.193 |
|
|||||||||||||
End point title |
Activation and elimination of free radicals | ||||||||||||
End point description |
GSH prefilter 24 hours after initiation RRT
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
24 hours after initiation RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
GSH 24 hours after initiation RRT | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
17
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [9] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
|||||||||||||
Notes [9] - 0.109 |
|
|||||||||||||
End point title |
Activation and elimination of free radicals | ||||||||||||
End point description |
GSH postfilter 24 hours after initiation RRT
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
24 hours after initiation RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
GSH postfilter 24 hours after initiation RRT | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
17
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [10] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
|||||||||||||
Notes [10] - 0.072 |
|
|||||||||||||
End point title |
Activation and elimination of free radicals | ||||||||||||
End point description |
Change in GSH prefilter/postfilter 24 hours after initiation RRT heparin
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
24 hours after initiation RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
GSH prefilter/postfilter 24 hours heparin | ||||||||||||
Comparison groups |
Heparin v Heparin
|
||||||||||||
Number of subjects included in analysis |
18
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [11] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
|||||||||||||
Notes [11] - 0.582 |
|
|||||||||||||
End point title |
Activation and elimination of free radicals | ||||||||||||
End point description |
Change in GSH prefilter/postfilter 24 hours after initiation RRT citrate
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
24 hours after initiation RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
GSH prefilter/postfilter 24 hours citrate | ||||||||||||
Comparison groups |
Citrate v Citrate
|
||||||||||||
Number of subjects included in analysis |
16
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [12] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
|||||||||||||
Notes [12] - 0.872 |
|
|||||||||||||
End point title |
Activation and elimination of free radicals | ||||||||||||
End point description |
GSSG at the beginning of RRT
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At the beginning of RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
GSSG at the beginning of RRT | ||||||||||||
Comparison groups |
Citrate v Heparin
|
||||||||||||
Number of subjects included in analysis |
19
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [13] | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
|||||||||||||
Notes [13] - 1.00 |
|
|||||||||||||
End point title |
Activation and elimination of free radicals | ||||||||||||
End point description |
GSSG prefilter 60 minutes after initiation of RRT
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
60 minutes after initiation of RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
GSSG prefilter 60 minutes | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
19
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [14] | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
|||||||||||||
Notes [14] - 0.315 |
|
|||||||||||||
End point title |
Activation and elimination of free radicals | ||||||||||||
End point description |
GSSG postfilter 60 minutes after initiation of RRT
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
60 minutes after initiation of RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
GSSG postfilter 60 minutes | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
19
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [15] | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
|||||||||||||
Notes [15] - 0.720 |
|
|||||||||||||
End point title |
Activation and elimination of free radicals | ||||||||||||
End point description |
Change in GSSG prefilter/postfilter 60 minutes after initiation RRT heparin
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
60 minutes after initiation of RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
GSSG prefilter/postfilter 60 minutes heparin | ||||||||||||
Comparison groups |
Heparin v Heparin
|
||||||||||||
Number of subjects included in analysis |
20
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [16] | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
|||||||||||||
Notes [16] - 0.678 |
|
|||||||||||||
End point title |
Activation and elimination of free radicals | ||||||||||||
End point description |
Chancge in GSSG prefilter/postfilter 60 minutes citrate
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
60 minutes after initiation RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
GSSG prefilter/postfilter 60 minutes citrate | ||||||||||||
Comparison groups |
Citrate v Citrate
|
||||||||||||
Number of subjects included in analysis |
18
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [17] | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
|||||||||||||
Notes [17] - 0.515 |
|
|||||||||||||
End point title |
Activation and elimination of free radicals | ||||||||||||
End point description |
GSSG prefilter 24 hours after initiation RRT
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
24 hours after initiation RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
GSSG 24 hours after initiation RRT | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
16
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [18] | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
|||||||||||||
Notes [18] - 0.105 |
|
|||||||||||||
End point title |
Activation and elimination of free radicals | ||||||||||||
End point description |
GSSG postfilter 24 hours after initiation RRT
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
24 hours after initiation RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
GSSG postfilter 24 hours after initiation RRT | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
16
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [19] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
|||||||||||||
Notes [19] - 0.118 |
|
|||||||||||||
End point title |
Activation and elimination of free radicals | ||||||||||||
End point description |
Change in GSSG prefilter/postfilter 24 hours after initiation RRT heparin
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
24 hours after initiation RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
GSSG prefilter/postfilter 24 hours heparin | ||||||||||||
Comparison groups |
Heparin v Heparin
|
||||||||||||
Number of subjects included in analysis |
16
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [20] | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
|||||||||||||
Notes [20] - 0.674 |
|
|||||||||||||
End point title |
Activation and elimination of free radicals | ||||||||||||
End point description |
Change in GSSG prefilter/postfilter 24 hours after initiation RRT citrate
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
24 hours after initiation RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
GSSG prefilter/postfilter 24 hours citrate | ||||||||||||
Comparison groups |
Citrate v Citrate
|
||||||||||||
Number of subjects included in analysis |
16
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [21] | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
|||||||||||||
Notes [21] - 0.401 |
|
|||||||||||||
End point title |
Activation and elimination of free radicals | ||||||||||||
End point description |
GSSG/GSH at the beginning of RRT
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At the beginning of RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
GSSG/GSH at the beginning of RRT | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
18
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
≤ 0.05 [22] | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
|||||||||||||
Notes [22] - 0.796 |
|
|||||||||||||
End point title |
Activation and elimination of free radicals | ||||||||||||
End point description |
GSSG/GSH prefilter 60 minutes after initiation of RRT
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
60 minutes after initiation of RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
GSSG/GSH prefilter 60 minutes after initiation RRT | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
19
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [23] | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
|||||||||||||
Notes [23] - 0.278 |
|
|||||||||||||
End point title |
Activation and elimination of free radicals | ||||||||||||
End point description |
GSSG/GSH postfilter 60 minutes after initiation of RRT
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
60 minutes after initiation of RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
GSSG/GSH postfilter 60 minutes after initiation | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
19
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [24] | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
|||||||||||||
Notes [24] - 0.278 |
|
|||||||||||||
End point title |
Activation and elimination of free radicals | ||||||||||||
End point description |
Change in GSSG/GSH prefilter/postfilter 60 minutes after initiation RRT heparin
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
60 minutes after initiation RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
GSSG/GSH prefilter/postfilter 60 minutes heparin | ||||||||||||
Comparison groups |
Heparin v Heparin
|
||||||||||||
Number of subjects included in analysis |
18
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [25] | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
|||||||||||||
Notes [25] - 0.086 |
|
|||||||||||||
End point title |
Activation and elimination of free radicals | ||||||||||||
End point description |
Change in GSSG/GSH prefilter/postfilter 60 minutes after initiation RRT citrate
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
60 minutes after initiation RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
GSSG/GSH prefilter/postfilter 60 minutes citrate | ||||||||||||
Comparison groups |
Citrate v Citrate
|
||||||||||||
Number of subjects included in analysis |
18
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [26] | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
|||||||||||||
Notes [26] - 0.441 |
|
|||||||||||||
End point title |
Activation and elimination of free radicals | ||||||||||||
End point description |
GSSG/GSH GSSG prefilter 24 hours after initiation RRT
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
24 hours after initiation RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
GSSG/GSH prefilter 24 hours after initiation | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
15
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [27] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Parameter type |
d Cohen | ||||||||||||
Point estimate |
1.659
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
0.484 | ||||||||||||
upper limit |
2.835 | ||||||||||||
Notes [27] - 0.007 |
|
|||||||||||||
End point title |
Activation and elimination of free radicals | ||||||||||||
End point description |
GSSG/GSH postfilter 24 hours after initiation RRT
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
24 hours after initiation RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
GSSG/GSH postfilter 24 hours after initiation | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
15
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [28] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Parameter type |
d Cohen | ||||||||||||
Point estimate |
-1.278
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-2.391 | ||||||||||||
upper limit |
-0.165 | ||||||||||||
Notes [28] - 0.028 |
|
|||||||||||||
End point title |
Activation and elimination of free radicals | ||||||||||||
End point description |
Change in GSSG/GSH prefilter/postfilter 24 hours after initiation RRT heparin
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
24 hours after initiation RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
GSSG/GSH prefilter/postfilter 24 hours heparin | ||||||||||||
Comparison groups |
Heparin v Heparin
|
||||||||||||
Number of subjects included in analysis |
12
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [29] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
|||||||||||||
Notes [29] - 0.543 |
|
|||||||||||||
End point title |
Activation and elimination of free radicals | ||||||||||||
End point description |
Change in GSSG/GSH prefilter/postfilter 24 hours after initiation RRT citrate
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
24 hours citrate
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
GSSG/GSH prefilter/postfilter 24 hours after | ||||||||||||
Comparison groups |
Citrate v Citrate
|
||||||||||||
Number of subjects included in analysis |
16
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [30] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
|||||||||||||
Notes [30] - 0.409 |
|
|||||||||||||
End point title |
Activation and elimination of biomarkers of inflammation | ||||||||||||
End point description |
MPO at the beginning of RRT
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At the beginning of RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
MPO at the beginning of RRT | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
19
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [31] | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
|||||||||||||
Notes [31] - 0.010 |
|
|||||||||||||
End point title |
Activation and elimination of biomarkers of inflammation | ||||||||||||
End point description |
MPO prefilter 60 minutes after initiation of RRT
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
60 minutes after initiation of RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
MPO prefilter 60 minutes | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
19
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [32] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
|||||||||||||
Notes [32] - 0.370 |
|
|||||||||||||
End point title |
Activation and elimination of biomarkers of inflammation | ||||||||||||
End point description |
MPO postfilter 60 minutes after initiation of RRT
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
60 minutes after initiation of RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
MPO postfilter 60 minutes | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
19
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [33] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Parameter type |
d Cohen | ||||||||||||
Point estimate |
-1.161
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-2.14 | ||||||||||||
upper limit |
-0.192 | ||||||||||||
Notes [33] - 0.022 |
|
|||||||||||||
End point title |
Activation and elimination of biomarkers of inflammation | ||||||||||||
End point description |
Change in MPO prefilter/postfilter 60 minutes after initiation RRT heparin
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
60 minutes after initiation of RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
MPO prefilter/postfilter 60 minutes heparin | ||||||||||||
Comparison groups |
Heparin v Heparin
|
||||||||||||
Number of subjects included in analysis |
18
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [34] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Parameter type |
d Cohen | ||||||||||||
Point estimate |
1.122
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
0.032 | ||||||||||||
upper limit |
2.02 | ||||||||||||
Notes [34] - 0.014 |
|
|||||||||||||
End point title |
Activation and elimination of biomarkers of inflammation | ||||||||||||
End point description |
MPO prefilter/postfilter 60 minutes citrate
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
60 minutes after initiation of RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
MPO prefilter/postfilter 60 minutes citrate | ||||||||||||
Comparison groups |
Citrate v Citrate
|
||||||||||||
Number of subjects included in analysis |
18
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [35] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
|||||||||||||
Notes [35] - 0.680 |
|
|||||||||||||
End point title |
Activation and elimination of biomarkers of inflammation | ||||||||||||
End point description |
MPO prefilter 24 hours after initiation RRT
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
24 hours after initiation RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
GSSG 24 hours after initiation RRT | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
17
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [36] | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
|||||||||||||
Notes [36] - 0.743 |
|
|||||||||||||
End point title |
Activation and elimination of biomarkers of inflammation | ||||||||||||
End point description |
MPO postfilter 24 hours after initiation RRT
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
24 hours after initiation RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
MPO postfilter 24 hours after initiation RRT | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
17
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [37] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
|||||||||||||
Notes [37] - 0.084 |
|
|||||||||||||
End point title |
Activation and elimination of biomarkers of inflammation | ||||||||||||
End point description |
Change in MPO prefilter/postfilter 24 hours after initiation RRT heparin
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
24 hours after initiation RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
MPO prefilter/postfilter 24 hours heparin | ||||||||||||
Comparison groups |
Heparin v Heparin
|
||||||||||||
Number of subjects included in analysis |
18
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [38] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
|||||||||||||
Notes [38] - 0.216 |
|
|||||||||||||
End point title |
Activation and elimination of biomarkers of inflammation | ||||||||||||
End point description |
Change in MPO prefilter/postfilter 24 hours after initiation RRT citrate
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
24 hours after initiation RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
MPO prefilter/postfilter 24 hours citrate | ||||||||||||
Comparison groups |
Citrate v Citrate
|
||||||||||||
Number of subjects included in analysis |
16
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [39] | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
|||||||||||||
Notes [39] - 0.263 |
|
|||||||||||||
End point title |
Activation and elimination of biomarkers of cell damage | ||||||||||||
End point description |
Circulating cell-free DNA (cfDNA) at the beginning of RRT
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At the beginning of RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
cfDNA at the beginning of RRT | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
20
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [40] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
|||||||||||||
Notes [40] - 0.184 |
|
|||||||||||||
End point title |
Activation and elimination of biomarkers of cell damage | ||||||||||||
End point description |
cfDNA prefilter 60 minutes after initiation of RRT
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
60 minutes after initiation of RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
cfDNA prefilter 60 minutes after initiation RRT | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
20
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [41] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
|||||||||||||
Notes [41] - 0.110 |
|
|||||||||||||
End point title |
Activation and elimination of biomarkers of cell damage | ||||||||||||
End point description |
cfDNA postfilter 60 minutes after initiation of RRT
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
60 minutes after initiation of RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
cfDNA postfilter 60 minutes after initiation RRT | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
20
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [42] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
|||||||||||||
Notes [42] - 0.216 |
|
|||||||||||||
End point title |
Activation and elimination of biomarkers of cell damage | ||||||||||||
End point description |
Change in cfDNA prefilter/postfilter 60 minutes after initiation RRT heparin
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
60 minutes after initiation RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
cfDNA prefilter/postfilter 60 minutes heparin | ||||||||||||
Comparison groups |
Heparin v Heparin
|
||||||||||||
Number of subjects included in analysis |
20
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [43] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
|||||||||||||
Notes [43] - 0.524 |
|
|||||||||||||
End point title |
Activation and elimination of biomarkers of cell damage | ||||||||||||
End point description |
Change in cfDNA prefilter/postfilter 60 minutes after initiation RRT citrate
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
60 minutes after initiation RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
cfDNA prefilter/postfilter 60 minutes citrate | ||||||||||||
Comparison groups |
Citrate v Citrate
|
||||||||||||
Number of subjects included in analysis |
20
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [44] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
|||||||||||||
Notes [44] - 0.448 |
|
|||||||||||||
End point title |
Activation and elimination of biomarkers of cell damage | ||||||||||||
End point description |
cfDNA prefilter 24 hours after initiation RRT
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
24 hours after initiation RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
cfDNA prefilter 24 hours after initiation RRT | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
16
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [45] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
|||||||||||||
Notes [45] - 0.240 |
|
|||||||||||||
End point title |
Activation and elimination of biomarkers of cell damage | ||||||||||||
End point description |
cfDNA postfilter 24 hours after initiation RRT
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
24 hours after initiation RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
cfDNA postfilter 24 hours after initiation RRT | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
16
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [46] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
|||||||||||||
Notes [46] - 0.062 |
|
|||||||||||||
End point title |
Activation and elimination of biomarkers of cell damage | ||||||||||||
End point description |
Change in cfDNA prefilter/postfilter 24 hours after initiation RRT heparin
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
24 hours after initiation RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
cfDNA prefilter/postfilter 24 hours heparin | ||||||||||||
Comparison groups |
Heparin v Heparin
|
||||||||||||
Number of subjects included in analysis |
16
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [47] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
|||||||||||||
Notes [47] - 0.075 |
|
|||||||||||||
End point title |
Activation and elimination of biomarkers of cell damage | ||||||||||||
End point description |
Change in cfDNA prefilter/postfilter 24 hours after initiation RRT citrate
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
24 hours after initiation RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
cfDNA prefilter/postfilter 24 hours citrate | ||||||||||||
Comparison groups |
Citrate v Citrate
|
||||||||||||
Number of subjects included in analysis |
16
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [48] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
|||||||||||||
Notes [48] - 0.805 |
|
|||||||||||||
End point title |
Mass transfer of free radicals | ||||||||||||
End point description |
Median levels of total amount of GSH mass removed expressed as a percentage of the filter inlet GSH mass
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
60 minutes after initiation of RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
GSH mass transfer 60 minutes | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
20
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [49] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Parameter type |
d Cohen | ||||||||||||
Point estimate |
1.055
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
0.102 | ||||||||||||
upper limit |
1.984 | ||||||||||||
Notes [49] - 0.030 |
|
|||||||||||||
End point title |
Mass transfer of free radicals | ||||||||||||
End point description |
Median levels of total amount of GSH mass removed expressed as a percentage of the filter inlet GSH mass
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
24 hours after initiation of RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
GSH mass transfer 24 hours | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
17
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [50] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
|||||||||||||
Notes [50] - 0.462 |
|
|||||||||||||
End point title |
Mass transfer of free radicals | ||||||||||||
End point description |
Median levels of total amount of GSSG mass removed expressed as a percentage of the filter inlet GSSG mass
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
60 minutes after initiation of RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
GSSG mass transfer 60 minutes | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
18
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [51] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
|||||||||||||
Notes [51] - 0.705 |
|
|||||||||||||
End point title |
Mass transfer of free radicals | ||||||||||||
End point description |
Median levels of total amount of GSSG mass removed expressed as a percentage of the filter inlet GSSG mass
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
24 hours after initiation of RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
GSSG mass transfer 24 hours | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
16
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [52] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
|||||||||||||
Notes [52] - 0.591 |
|
|||||||||||||
End point title |
Mass transfer of biomarkers of inflammation | ||||||||||||
End point description |
Median levels of total amount of MPO mass removed expressed as a percentage of the filter inlet MPO mass
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
60 minutes after initiation RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
MPO mass transfer 60 minutes | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
18
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [53] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Parameter type |
d Cohen | ||||||||||||
Point estimate |
-1.263
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-2.272 | ||||||||||||
upper limit |
-0.221 | ||||||||||||
Notes [53] - 0.017 |
|
|||||||||||||
End point title |
Mass transfer of biomarkers of inflammation | ||||||||||||
End point description |
Median levels of total amount of MPO mass removed expressed as a percentage of the filter inlet MPO mass
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
24 hours after initiation of RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
MPO mass transfer 24 hours | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
17
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [54] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
|||||||||||||
Notes [54] - 0.089 |
|
|||||||||||||
End point title |
Mass transfer of biomarkers of inflammation | ||||||||||||
End point description |
Median levels of total amount of CRP mass removed expressed as a percentage of the filter inlet CRP mass
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
60 minutes after initiation RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
CRP mass transfer 60 minutes | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
20
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [55] | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Parameter type |
g Hedges | ||||||||||||
Point estimate |
-0.964
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-1.848 | ||||||||||||
upper limit |
-0.056 | ||||||||||||
Notes [55] - 0.023 |
|
|||||||||||||
End point title |
Mass transfer of biomarkers of inflammation | ||||||||||||
End point description |
Median levels of total amount of CRP mass removed expressed as a percentage of the filter inlet CRP mass
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
24 hours after initiation of RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
CRP mass transfer 24 hours | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
15
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [56] | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Parameter type |
g Hedges | ||||||||||||
Point estimate |
-1.521
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-2.616 | ||||||||||||
upper limit |
-0.383 | ||||||||||||
Notes [56] - 0.021 |
|
|||||||||||||
End point title |
Mass transfer of biomarkers of cell damage | ||||||||||||
End point description |
Median levels of total amount of cfDNA mass removed expressed as a percentage of the filter inlet cfDNA mass
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
60 minutes after initiation RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
DNA mass transfer 60 minutes | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
20
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [57] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
|||||||||||||
Notes [57] - 0.920 |
|
|||||||||||||
End point title |
Mass transfer of biomarkers of cell damage | ||||||||||||
End point description |
Median levels of total amount of cfDNA mass removed expressed as a percentage of the filter inlet cfDNA mass
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
24 hours after initiation of RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
cfDNA mass transfer 24 hours | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
16
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Parameter type |
g Hedges | ||||||||||||
Point estimate |
-0.8
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-1.86 | ||||||||||||
upper limit |
0.196 |
|
|||||||||||||
End point title |
Clearance rate of free radicals | ||||||||||||
End point description |
GSH clearance rate 60 minutes after initiation RRT
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
60 minutes after initiation RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
GSH clearance rate 60 minutes | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
20
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [58] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Parameter type |
d Cohen | ||||||||||||
Point estimate |
1.193
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
0.221 | ||||||||||||
upper limit |
2.138 | ||||||||||||
Notes [58] - 0.016 |
|
|||||||||||||
End point title |
Clearance rate of free radicals | ||||||||||||
End point description |
GSH clearance 24 hours after initiation of RRT
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
24 hours after initiation of RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
GSH clearance rate 24 hours | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
17
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [59] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
|||||||||||||
Notes [59] - 0.350 |
|
|||||||||||||
End point title |
Clearance rate of free radicals | ||||||||||||
End point description |
GSH mean clearance 24 hours after initiation of RRT
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
24 hours after initiation of RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
GSH mean clearance rate | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
15
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [60] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
|||||||||||||
Notes [60] - 0.230 |
|
|||||||||||||
End point title |
Clearance rate of free radicals | ||||||||||||
End point description |
GSSG clearance 60 minutes after initiation of RRT
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
60 minutes after initiation of RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
GSSG clearance rate 60 minutes | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
18
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [61] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
|||||||||||||
Notes [61] - 0.554 |
|
|||||||||||||
End point title |
Clearance rate of free radicals | ||||||||||||
End point description |
GSSG clearance 24 hours after initiation of RRT
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
24 hours after initiation of RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
GSSG clearance rate 24 hours | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
16
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [62] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
|||||||||||||
Notes [62] - 0.658 |
|
|||||||||||||
End point title |
Clearance rate of free radicals | ||||||||||||
End point description |
GSSG mean clearance 24 hours after initiation of RRT
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
24 hours after initiation of RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
GSSG mean clearance rate | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
17
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [63] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
|||||||||||||
Notes [63] - 0.297 |
|
|||||||||||||
End point title |
Clearance of biomarkers of inflammation | ||||||||||||
End point description |
MPO clearance 60 minutes after initiation RRT
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
60 minutes after initiation RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
MPO clearance rate 60 minutes | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
19
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [64] | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
|||||||||||||
Notes [64] - 0.133 |
|
|||||||||||||
End point title |
Clearance of biomarkers of inflammation | ||||||||||||
End point description |
MPO clearance 24 hours after initiation of RRT
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
24 hours after initiation of RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
MPO clearance rate 24 hours | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
17
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [65] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
|||||||||||||
Notes [65] - 0.256 |
|
|||||||||||||
End point title |
Clearance of biomarkers of inflammation | ||||||||||||
End point description |
MPO mean clearance 24 hours after initiation of RRT
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
24 hours after initiation of RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
MPO mean clearance rate | ||||||||||||
Comparison groups |
Citrate v Heparin
|
||||||||||||
Number of subjects included in analysis |
17
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [66] | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Parameter type |
g Hedges | ||||||||||||
Point estimate |
-0.685
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-1.611 | ||||||||||||
upper limit |
0.261 | ||||||||||||
Notes [66] - 0.046 |
|
|||||||||||||
End point title |
Clearance of biomarkers of inflammation | ||||||||||||
End point description |
CRP clearance 60 minutes after initiation of RRT
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
60 minutes after initiation of RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
CRP clearance rate 60 minutes | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
20
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [67] | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Parameter type |
g Hedges | ||||||||||||
Point estimate |
-0.692
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-1.552 | ||||||||||||
upper limit |
0.186 | ||||||||||||
Notes [67] - 0.019 |
|
|||||||||||||
End point title |
Clearance of biomarkers of inflammation | ||||||||||||
End point description |
CRP clearance 24 hours after initiation of RRT
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
24 hours after initiation of RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
CRP clearance rate 24 hours | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
16
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [68] | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Parameter type |
g Hedges | ||||||||||||
Point estimate |
-1.015
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-1.998 | ||||||||||||
upper limit |
-0.001 | ||||||||||||
Notes [68] - 0.010 |
|
|||||||||||||
End point title |
Clearance of biomarkers of inflammation | ||||||||||||
End point description |
CRP mean clearance 24 hours after initiation of RRT
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
24 hours after initiation of RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
CRP mean clearance rate | ||||||||||||
Comparison groups |
Citrate v Heparin
|
||||||||||||
Number of subjects included in analysis |
16
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [69] | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Parameter type |
g Hedges | ||||||||||||
Point estimate |
-1.25
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-2.265 | ||||||||||||
upper limit |
-0.198 | ||||||||||||
Notes [69] - 0.015 |
|
|||||||||||||
End point title |
Clearance of biomarkers of cell damage | ||||||||||||
End point description |
cfDNA clearance 60 minutes after initiation of RRT
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
60 minutes after initiation of RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
cfDNA clearance rate 60 minutes | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
20
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [70] | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
|||||||||||||
Notes [70] - 0.853 |
|
|||||||||||||
End point title |
Clearance of biomarkers of cell damage | ||||||||||||
End point description |
cfDNA clearance 24 hours after initiation of RRT
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
24 hours after initiation of RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
cfDNA clearance rate 24 hours | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
16
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [71] | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
|||||||||||||
Notes [71] - 0.050 |
|
|||||||||||||
End point title |
Clearance of biomarkers of cell damage | ||||||||||||
End point description |
cfDNA mean clearance 24 hours after initiation of RRT
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
24 hours after initiation of RRT
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
cfDNA mean clearance rate | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
15
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [72] | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
|||||||||||||
Notes [72] - 0.054 |
|
|||||||||||||
End point title |
Length of stay | ||||||||||||
End point description |
ICU length of stay from ICU admission until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 90 days
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From ICU admission until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 90 days
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
ICU length of stay | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
20
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [73] | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
|||||||||||||
Notes [73] - 0.165 |
|
|||||||||||||
End point title |
Length of stay | ||||||||||||
End point description |
Hospital length of stay
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From hospital admission until the date of documented hospital discharge or date of death from any cause, whichever came first, assessed up to 90 days
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Hospital length of stay | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
20
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [74] | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
|||||||||||||
Notes [74] - 0.853 |
|
|||||||||||||
End point title |
Mortality | ||||||||||||
End point description |
ICU mortality
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Through study completion, an average of 20 days
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
ICU mortality | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
20
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [75] | ||||||||||||
Method |
Chi-squared corrected | ||||||||||||
Confidence interval |
|||||||||||||
Notes [75] - 1.000 |
|
|||||||||||||
End point title |
Mortality | ||||||||||||
End point description |
Hospital mortality
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 90 after ICU admission
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Hospital mortality | ||||||||||||
Comparison groups |
Heparin v Citrate
|
||||||||||||
Number of subjects included in analysis |
20
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [76] | ||||||||||||
Method |
Chi-squared corrected | ||||||||||||
Confidence interval |
|||||||||||||
Notes [76] - 1.000 |
|
||||||||||||||||||||||
Adverse events information
|
||||||||||||||||||||||
Timeframe for reporting adverse events |
24 hours
|
|||||||||||||||||||||
Assessment type |
Systematic | |||||||||||||||||||||
Dictionary used for adverse event reporting
|
||||||||||||||||||||||
Dictionary name |
MedDRA | |||||||||||||||||||||
Dictionary version |
5.0
|
|||||||||||||||||||||
Reporting groups
|
||||||||||||||||||||||
Reporting group title |
Active Comparator : Heparin
|
|||||||||||||||||||||
Reporting group description |
- | |||||||||||||||||||||
Reporting group title |
Experimental : Citrate
|
|||||||||||||||||||||
Reporting group description |
- | |||||||||||||||||||||
|
||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||||||||
|
|
|||||||
Substantial protocol amendments (globally) |
|||||||
Were there any global substantial amendments to the protocol? Yes | |||||||
Date |
Amendment |
||||||
15 Jul 2019 |
Addition of research center and designated researcher |
||||||
Interruptions (globally) |
|||||||
Were there any global interruptions to the trial? Yes | |||||||
|
|||||||
Limitations and caveats |
|||||||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||||||
Early termination leading to a small number of subjects analysed |