Clinical Trial Results:
Cardiac and renal interactions during the treatment of decompensated heart failure: diuretics versus ultrafiltration (CRUF Trial)
Summary
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EudraCT number |
2009-017589-22 |
Trial protocol |
BE |
Global end of trial date |
21 Oct 2011
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Results information
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Results version number |
v1(current) |
This version publication date |
30 Jul 2021
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First version publication date |
30 Jul 2021
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Other versions |
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Summary report(s) |
Statement of discontinuation |
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 |
AGO/2009/013
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Ghent University Hospital
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Sponsor organisation address |
Corneel Heymanslaan 10, Ghent, Belgium, 9000
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Public contact |
Hiruz CTU, Ghent University Hospital, +32 93320500, hiruz.ctu@uzgent.be
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Scientific contact |
Hiruz CTU, Ghent University Hospital, +32 93320500, hiruz.ctu@uzgent.be
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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 |
21 Oct 2011
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
21 Oct 2011
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Global end of trial reached? |
Yes
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Global end of trial date |
21 Oct 2011
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To understand cardiorenal interactions when treated with ultrafiltration versus diuretics for decompensated heart failure to better select patients who will benefit from ultrafiltration in the future.
To determine if there are differences in:
a. Influence on renal congestion of diuretics versus ultrafiltration; intra-abdominal pressure as a parameter of renal congestion,
b. Influence of diuretics versus ultrafiltration on plasma refill rate: plasma hematocrit as a measure of dilution
c. Influence of diuretics versus ultrafiltration on echocardiographic filling parameters and hydration state via bioelectrical impedance.
d. Influence on urinary potassium/sodium excretion with diuretics versus ultrafiltration.
e. Impact on a new renal biomarker: urinary and plasma NGAL (vs creatinine, cystatin C, measured urinary creat clearance) for detection acute renal insufficiency when administering diuretics versus ultrafiltration.
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Protection of trial subjects |
Ethics review and approval, informed consent, supportive care and routine monitoring.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
15 Apr 2010
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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 |
Belgium: 1
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Worldwide total number of subjects |
1
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EEA total number of subjects |
1
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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) |
0
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From 65 to 84 years |
1
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85 years and over |
0
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Recruitment
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Recruitment details |
1 patient was screened in the period from 15-04-2010 till 21-10-2011. 1 patient was enrolled in the diuretics group. Due to limitations of the system, the number of patients that entered ultrafiltration group was defined as 1, the number of completion as 0. End of Trial notification was dated 21/10/2011 and submitted to EC and CA 21/10/2011. | |||||||||||||||
Pre-assignment
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Screening details |
Inclusion criteria: Severe systolic heart failure, ejection fraction < 40% and admission with acute decompensated heart failure: NYHA class III-IV + 1 of the following: Vena Jugularis distension >6cm - Diastolic function echo: E/E'medial >15, lateral>12 - RX thorax: pulmonary edema-pleural fluid. Minimum 18 years of age | |||||||||||||||
Period 1
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Period 1 title |
Overall Trial (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||
Arms
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Are arms mutually exclusive |
No
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Arm title
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ultrafiltration group | |||||||||||||||
Arm description |
No patients were enrolled in the ultrafiltration group. Due to technical limitations of the system the number of subjects that started this arm was defined as 1 and the number of patients that completed the arm was defined as 0. Procedure: Ultrafiltration through double lumen catheter, via central vein. | |||||||||||||||
Arm type |
procedure | |||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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diuretics group | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
Bumetanide
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Investigational medicinal product code |
CAS 28395031
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Other name |
Burinex
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Pharmaceutical forms |
Injection
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Routes of administration |
Intravenous use
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Dosage and administration details |
Maximum duration of treatment of a subject: 72 hours
Maximum dose allowed: Dose per day, 1 mg/h milligram(s)/hour
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Baseline characteristics reporting groups
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Reporting group title |
ultrafiltration group
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Reporting group description |
No patients were enrolled in the ultrafiltration group. Due to technical limitations of the system the number of subjects that started this arm was defined as 1 and the number of patients that completed the arm was defined as 0. Procedure: Ultrafiltration through double lumen catheter, via central vein. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
diuretics group
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
ultrafiltration group
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Reporting group description |
No patients were enrolled in the ultrafiltration group. Due to technical limitations of the system the number of subjects that started this arm was defined as 1 and the number of patients that completed the arm was defined as 0. Procedure: Ultrafiltration through double lumen catheter, via central vein. | ||
Reporting group title |
diuretics group
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Reporting group description |
- |
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End point title |
Incidence of AKI and determining factors in patients with acute decompensated heart failure with treated with ultrafiltration versus diuretics [1] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
At 6 months
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis available. |
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Notes [2] - No patients were enrolled in this group. |
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No statistical analyses for this end point |
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End point title |
Combined endpoint of mortality/rehospitalisation-urgent outpatient visit due to heart failure | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
At 6 months
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Notes [3] - No patients were enrolled in this group. |
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No statistical analyses for this end point |
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End point title |
Determination of the value of Neutrophil gelatinase-associated lipocalin (NGAL) to predict AKI in acute decompensated heart failure (vs creatinine, Cystatin C,measured urinary creatinine clearance) in patients treated with diuretics vs ultrafiltration. | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
At 48h after treatment start
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Notes [4] - No patients were enrolled in this group. |
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No statistical analyses for this end point |
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End point title |
Kidney function measured by creatinine | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
After 28 days and 6 months
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Notes [5] - No patients were enrolled in this group. |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
Overall study
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Assessment type |
Non-systematic | ||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||
Dictionary version |
12.1
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Reporting groups
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Reporting group title |
diuretics group
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Reporting group description |
- | ||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||
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Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No non-serious adverse events were recorded for the participating patients. |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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27 May 2010 |
Reasons for the substantial amendment: changes in interpretation of scientific documents/value of the trial, changes in conduct or management of the trial.
Reasons for substantial amendment: Amendment of an inclusion criterion
Brief description of the changes: Change of one inclusion criterion: age minimum 18 years instead of patients between 18 and 75 years |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
Given the poor inclusion, the study was discontinued. |