drugset / Trial / NCT03677622

Restrictive or Doppler-guided Fluid Treatment in Colorectal Surgery

NCT03677622 ↗

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2008-03-01
Primary completion
2009-07-31
Completion
2009-08-31

Outcome

Missed primary endpoint

paper No significant differences between the groups were found for overall, major, minor, cardiopulmonary, or tissue-healing complications (P-values: 0.79; 0.62; 0.97; 0.48; and 0.48, respectively). PMID 22710266 ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Voluven Unknown 200 ml —

Indications

No indication recorded.