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

July 29, 2010
September 21, 2011
April 2010
July 2012   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01175317 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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 Blind (Subject)
Primary Purpose: Treatment
Colorectal Surgery
  • 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: Control group.
    Fluid regimen based on expertise anaesthesist.
  • Experimental: Group 2
    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
  • Group 1
    Fluid regimen based on expertise anaesthesist.
    Intervention: Other: Control group.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
58
Not Provided
July 2012   (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.
Both
18 Years and older
No
Contact: Kostan W Reisinger, MD +31433882125 k.reisinger@maastrichtuniversity.nl
Netherlands
 
NCT01175317
MEC 09-2-089
Yes
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
September 2011

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