Clinical Trial Results:
GDT in Urgent Abdominal Surgery - A Clinical Randomized Trial
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Summary
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EudraCT number |
2015-000563-14 |
Trial protocol |
DK |
Global end of trial date |
05 Nov 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
23 May 2020
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First version publication date |
23 May 2020
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Other versions |
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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 |
2014-734
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Holbaek Sygehus, Department of Surgery
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Sponsor organisation address |
Smedelundsgade 60, Holbaek, Denmark, 4300
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Public contact |
Surgical department, att. GAS-ART, Holbaek Sygehus, Research unit, +45 594840004344, bbrn@regionsjaelland.dk
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Scientific contact |
Surgical department, att. GAS-ART, Holbaek Sygehus, Research unit, +45 594840004344, bbrn@regionsjaelland.dk
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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 |
04 Dec 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
05 Nov 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
05 Nov 2018
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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 |
We hypothesized that IV-fluid therapy to near maximum stroke volume followed by zero fluid balance could improve the outcome of patients undergoing major emergency surgery compared to IV-fluid therapy guided by blood pressure.
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Protection of trial subjects |
Treated in routine care.
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Background therapy |
Standard surgical and medical care of obstructive bowel disease or gastrointestinal perforation. | ||
Evidence for comparator |
Best known standard of peroperative fluid care in patients undergoing emergency surgery for bowel obstruction or gastrointestinal perforation (according to PULP-trial and River´s study in patients with sepsis). | ||
Actual start date of recruitment |
01 Aug 2015
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Scientific research | ||
Long term follow-up duration |
3 Months | ||
Independent data monitoring committee (IDMC) involvement? |
Yes
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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 |
Denmark: 304
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Worldwide total number of subjects |
304
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EEA total number of subjects |
304
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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) |
113
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From 65 to 84 years |
151
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85 years and over |
40
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Recruitment
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Recruitment details |
Recruitment from 5 centres. August 2015 to august 2018. | |||||||||
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Pre-assignment
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Screening details |
We screened patients with radiologically verified obstructive bowel disease or gastrointestinal perforation. Exclusion criteria was ASA 5, intraabdominal surgery within the last 30 days, dialysis on a regular basis, patients unable to give informed consent, children, pregnant women. | |||||||||
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Period 1
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Period 1 title |
Intervention (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
Blinding implementation details |
Assessor blinding
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Flow controlled group | |||||||||
Arm description |
Fluid therapy controlled by stroke volume. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Saline solution
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Investigational medicinal product code |
PR2
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Other name |
Sodium chloride solution 0.9%
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Per day up to 4000 ml (adjusted individually) administered intravenously
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Investigational medicinal product name |
Human Albumin 5%
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Investigational medicinal product code |
PR1
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Other name |
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Pharmaceutical forms |
Infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Per day up to 4000 ml (adjusted individually) administered intravenously.
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Investigational medicinal product name |
Ringer's solution
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Investigational medicinal product code |
PR3
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Other name |
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Pharmaceutical forms |
Infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Per day up to 4000 ml (adjusted individually) administered intravenously
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Arm title
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Pressure controlled group | |||||||||
Arm description |
Standard fluid therapy | |||||||||
Arm type |
No intervention | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Baseline characteristics reporting groups
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Reporting group title |
Flow controlled group
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Reporting group description |
Fluid therapy controlled by stroke volume. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Pressure controlled group
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Reporting group description |
Standard fluid therapy | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Flow controlled group
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Reporting group description |
Fluid therapy controlled by stroke volume. | ||
Reporting group title |
Pressure controlled group
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Reporting group description |
Standard fluid therapy | ||
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End point title |
Primary end point | |||||||||
End point description |
Major complications defined by Clavien-Dindo grade IIIb to grade V.
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End point type |
Primary
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End point timeframe |
Follow up 30 days and 90 days.
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Statistical analysis title |
Primary endpoint | |||||||||
Comparison groups |
Pressure controlled group v Flow controlled group
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Number of subjects included in analysis |
304
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
< 0.05 | |||||||||
Method |
Fisher exact | |||||||||
Parameter type |
Log hazard ratio | |||||||||
Confidence interval |
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End point title |
Secondary end points | |||||||||
End point description |
Clavien-Dindo grade I to grade IIIa.
Length of stay, time with mechanical respiratory support, time on dialysis, time in the intensive care unit.
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End point type |
Secondary
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End point timeframe |
From time of surgery and until 30 days postoperative.
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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 |
Peri- and postoperative until hospital discharge.
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Adverse event reporting additional description |
Event suspected directly related to the infusion of saline, albumin or Ringer's solution: acute anaphylactic reaction, hypernatremia (s-Na>155mmol/L), central pontine myelinolysis or seizures.
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Assessment type |
Systematic | ||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||
Dictionary version |
18
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Reporting groups
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Reporting group title |
Flow
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Reporting group description |
GDT | ||||||||||||||||||||
| 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: Not relevant |
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
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. | |||
| None reported | |||
