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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01175317
First received: July 29, 2010
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Colorectal Carcinoma
Procedure: Goal-directed fluid optimization
Other: Regimen based on expertise anaesthesist
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Does Hemodynamic Optimization During and After Colorectal Surgery Result in Improved Intestinal Perfusion, Sustained Intestinal Barrier and Improved Postoperative Recovery?

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Peak Value of I-FABP [ Time Frame: 1 hour postoperatively ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Average Intraoperative CO2 Gap [ Time Frame: Average intraoperative CO2 gap ] [ Designated as safety issue: No ]

    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.



Enrollment: 58
Study Start Date: April 2010
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Regimen based on expertise anaesthesist
Fluid regimen based on expertise anaesthesist
Other: Regimen based on expertise anaesthesist
Fluid regimen based on expertise anaesthesist

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01175317

Locations
Netherlands
University Hospital Maastricht
Maastricht, Limburg, Netherlands, 6229 HX
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01175317     History of Changes
Other Study ID Numbers: MEC 09-2-089
Study First Received: July 29, 2010
Results First Received: November 5, 2013
Last Updated: May 19, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Hemodynamic optimization
Enhanced recovery after surgery
Goal-directed fluid

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on October 19, 2014