CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 150 enrolled
Drug / intervention
Voluven to near maximal stroke volume of the heartdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03677622
NCT03677622N/ACompleted

Which Goal for Fluid Therapy During Colorectal Surgery is Followed by the Best Outcome: Near Maximal Stroke Volume or Restricted Fluid Therapy

Holbaek Sygehus·interventional·Posted Sep 19, 2018·Updated Oct 5, 2018

In Brief

A clinical study evaluating Voluven to near maximal stroke volume of the heart for Fluid Overload. Completed, enrolled 150 participants.

Detailed Summary

This is a clinical randomised double blinded multicentre trial of two different fluid treatments during colorectal surgery in an enhanced recovery programme A restricted fluid regimen aiming at zero fluid balance and less than two kilograms bodyweight change was compared with another fluid regimen where intravenous fluids were given to reach near maximal stroke volume of the heart, guided by a Doppler in the oesophagus. The primary outcome was a composite outcome of postoperative complications and death. Included was 150 patients undergoing elective colorectal surgery. No difference was found between the two groups. Both fluid therapies resulted in low complication rates. The difference in fluid volume between the groups was only 600 ml on the day of operation. The results are published, see reference section.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFluid Overload
Countries--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 19, 2018
Enrollment StartMar 1, 2008
Primary CompletionJul 31, 2009
Study CompletionAug 31, 2009
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 7.8 years ago

Interventions

Voluven to near maximal stroke volume of the heartdrug

Stroke volume guided fluid treatment with Voluven on the basis of restricted fluid therapy