Improvement of Fluid Balance in Patients Undergoing Surgery of the Colon and Rectum (HOC)

May 19, 2014 updated by: Maastricht University Medical Center

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229 HX
        • University Hospital Maastricht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients undergoing elective colorectal surgery with anastomosis;
  • Minimum age 18 years;
  • Giving informed consent.

Exclusion Criteria:

  • Other causes of intestinal damage: eg. IBD, occlusive disease;
  • Steroid use;
  • Esophageal varices and other esophageal disease;
  • Aortic valve disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Goal-directed fluid optimization
Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.
Procedure: Goal-directed fluid optimization
Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.
Other: Regimen based on expertise anaesthesist
Fluid regimen based on expertise anaesthesist
Other: Regimen based on expertise anaesthesist
Fluid regimen based on expertise anaesthesist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak Value of I-FABP
Time Frame: 1 hour postoperatively

Intestinal-Fatty Acid Binding Protein (a marker of intestinal damage) is measured in plasma.

The primary outcome measure is the difference in peak values of I-FABP between the control group and the intervention group.
1 hour postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Intraoperative CO2 Gap
Time Frame: Average intraoperative CO2 gap

The CO2 gap (difference arterial pCO2 and pCO2 of the stomach lumen) reflects global intestinal perfusion status and is measured every 15 minutes intraoperatively and every 60 minutes during the first 8 hours postoperatively.

Intraoperative measurements were averaged per individual patient, producing the average intraoperative CO2 gap.
Average intraoperative CO2 gap

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Study Director: Maarten F Von Meyenfeldt, MD, PhD, Maastricht University Medical Center
  • Study Director: Martijn Poeze, MD, PhD, Maastricht University Medical Center
  • Study Director: Geerard L Beets, MD, PhD, Maastricht University Hospital
  • Study Director: Wim A Buurman, PhD, Maastricht University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

July 29, 2010

First Submitted That Met QC Criteria

August 3, 2010

First Posted (Estimate)

August 4, 2010

Study Record Updates

Last Update Posted (Estimate)

June 19, 2014

Last Update Submitted That Met QC Criteria

May 19, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC 09-2-089

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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