CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 58 enrolled
Drug / intervention
Goal-directed fluid optimization +1 moreprocedure
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/NCT01175317
NCT01175317Phase 4Completed

Does Hemodynamic Optimization During and After Colorectal Surgery Result in Improved Intestinal Perfusion, Sustained Intestinal Barrier and Improved Postoperative Recovery?

Maastricht University Medical Center·interventional·Posted Aug 4, 2010·Updated Jun 19, 2014

In Brief

A Phase 4 clinical trial evaluating Goal-directed fluid optimization and Regimen based on expertise anaesthesist for Colorectal Carcinoma. Completed, enrolled 58 participants across 1 site.

Detailed Summary

58 patients undergoing surgery of the large bowel are divided into two groups. The control group will receive standard care. The intervention group will receive standard care plus optimization of the blood circulation based on in- or decrease of the output of the heart. Between group differences are measured primarily by markers of intestinal damage in plasma and urine. Also CO2 pressure in the stomach lumen is measured (reflecting blood supply to the gut). The investigators hypothesize that the intervention group will have less intestinal damage, improved blood supply to the bowel and improved recovery of the operation compared to the control group.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNetherlands
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 4, 2010
Enrollment StartApr 1, 2010
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 15.9 years ago

Interventions

Goal-directed fluid optimizationprocedure

Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.

Regimen based on expertise anaesthesistother

Fluid regimen based on expertise anaesthesist