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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Maastricht University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01175317
First received: July 29, 2010
Last updated: September 21, 2011
Last verified: September 2011
  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 Surgery
Procedure: Goal-directed fluid optimization
Other: Control group.
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:
  • Difference in 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:
  • L-FABP [ Time Frame: Every 30 minutes intraoperatively; every 60 minutes during the first 10 hours postoperatively; daily during 5 days postoperatively. ] [ Designated as safety issue: No ]
    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. ] [ 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 10 hours postoperatively.


Estimated Enrollment: 58
Study Start Date: April 2010
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 2
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.
Group 1
Fluid regimen based on expertise anaesthesist.
Other: Control group.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01175317

Contacts
Contact: Kostan W Reisinger, MD +31433882125 k.reisinger@maastrichtuniversity.nl

Locations
Netherlands
University Hospital Maastricht Recruiting
Maastricht, Limburg, Netherlands, 6229 HX
Contact: Kostan W Reisinger, MD    +31433882125    k.reisinger@maastrichtuniversity.nl   
Principal Investigator: Kostan W Reisinger, MD         
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
Last Updated: September 21, 2011
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

ClinicalTrials.gov processed this record on April 22, 2014