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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01175317
First Posted: August 4, 2010
Last Update Posted: June 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Maastricht University Medical Center
July 29, 2010
August 4, 2010
November 5, 2013
June 19, 2014
June 19, 2014
April 2010
October 2013   (Final data collection date for primary outcome measure)
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.

Difference in 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.

Complete list of historical versions of study NCT01175317 on ClinicalTrials.gov Archive Site
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.

  • L-FABP [ Time Frame: Every 30 minutes intraoperatively; every 60 minutes during the first 10 hours postoperatively; daily during 5 days postoperatively. ]
    Liver-Fatty Acid Binding Protein (another, but less specific marker of intestinal damage) is measured in plasma.
  • CO2 gap [ Time Frame: Every 15 minutes intraoperatively; every 60 minutes in the first 10 hours postoperatively. ]
    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 10 hours postoperatively.
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Improvement of Fluid Balance in Patients Undergoing Surgery of the Colon and Rectum
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Colorectal Carcinoma
  • 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
  • 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.
    Intervention: Procedure: Goal-directed fluid optimization
  • Regimen based on expertise anaesthesist
    Fluid regimen based on expertise anaesthesist
    Intervention: Other: Regimen based on expertise anaesthesist
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
October 2013
October 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT01175317
MEC 09-2-089
Yes
Not Provided
Not Provided
Maastricht University Medical Center
Maastricht University Medical Center
Not Provided
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
Maastricht University Medical Center
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP