Clinical Trial Results:
Perioperative fluid management in patients receiving major abdominal surgery – Effects of normal saline versus an acetate buffered balanced infusion solution on the necessity of catecholamines for cardiocirculatory support
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Summary
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EudraCT number |
2014-004867-19 |
Trial protocol |
AT |
Global end of trial date |
28 Apr 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
26 Oct 2017
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First version publication date |
26 Oct 2017
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Other versions |
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Summary report(s) |
Summary |
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 |
v1330032015
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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 |
Medical University of Vienna
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Sponsor organisation address |
Waehringerguertel 18-22, Vienna, Austria,
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Public contact |
Head of Department, Clinic for General Anesthesiology, Intensive Care and Pain Management, 0041 140100, anesthesie@meduniwien.ac.at
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Scientific contact |
Head of Department, Clinic for General Anesthesiology, Intensive Care and Pain Management, 0041 140100, anesthesie@meduniwien.ac.at
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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 |
28 Aug 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
28 Apr 2016
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Global end of trial reached? |
Yes
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Global end of trial date |
28 Apr 2016
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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 |
In this study we want to clarify whether a balanced type fluid solution for perioperative fluid management of patients receiving major abdominal surgery is associated with a lower incidence of need for catecholamines for hemodynamic stability than use of isotonic saline.
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Protection of trial subjects |
Patients were monitored closely during and after operation.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Mar 2015
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Long term follow-up planned |
No
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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 |
Austria: 60
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Worldwide total number of subjects |
60
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EEA total number of subjects |
60
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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) |
45
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From 65 to 84 years |
15
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85 years and over |
0
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Recruitment
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Recruitment details |
All patients scheduled for open elective major abdominal surgery and expected to last a minimum of 2 hours were included in the study. | |||||||||
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Pre-assignment
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Screening details |
Major general surgery includes complex visceral resection, partial or total colectomy, stomach surgery, small bowel resection, open gall-bladder resection, splenektomie, adrenalektomie and regional lymphnode dissection, major urological or gynecological surgery. | |||||||||
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Period 1
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Period 1 title |
periooperative (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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0.9% NaCl | |||||||||
Arm description |
- | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
0.9% NaCl
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Investigational medicinal product code |
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Other name |
normal saline
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Pharmaceutical forms |
Infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
During the perioperative periode patients received a baseline infusion and fluid resuscitation with the study fluid.
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Arm title
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acetate-buffered | |||||||||
Arm description |
- | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Elomel isoton
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Investigational medicinal product code |
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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 |
During the perioperative period patients received a continous infusion and fluid resuscitation with the study fluid.
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End points reporting groups
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Reporting group title |
0.9% NaCl
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Reporting group description |
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Reporting group title |
acetate-buffered
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Reporting group description |
- | ||
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End point title |
need for vasocative agents | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
during the perioperative period
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Statistical analysis title |
Wilcoxon | |||||||||
Comparison groups |
0.9% NaCl v acetate-buffered
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Number of subjects included in analysis |
60
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | |||||||||
P-value |
< 0.05 | |||||||||
Method |
Wilcoxon (Mann-Whitney) | |||||||||
Confidence interval |
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End point title |
cumulative dose of vasoactive agents | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
perioperative period
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| No statistical analyses for this end point | |||||||||||||
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End point title |
changes in electrolyte and acid base status | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
perioperative periode
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| No statistical analyses for this end point | |||||||||||||
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End point title |
unexpected ICU transfers | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
perioperative period
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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 |
From the start of anesthesia to the end of anesthesia.
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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 |
1
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| Frequency threshold for reporting non-serious adverse events: 5% | |||
| 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 serious adverse events were recorded: In this trial, the following events were considered to be efficacy and safety outcomes and are not considered an SAE: hypotension, shock, need for intropes, need for kolloid fluids, need for blood transfusion, need for expected and unexpected intensive care unit transfer. |
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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 | |||
