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

Primary Purpose

Colorectal Carcinoma

Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Goal-directed fluid optimization
Regimen based on expertise anaesthesist
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Carcinoma focused on measuring Hemodynamic optimization, Enhanced recovery after surgery, Goal-directed fluid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital Maastricht

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Goal-directed fluid optimization

Regimen based on expertise anaesthesist

Arm Description

Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.

Fluid regimen based on expertise anaesthesist

Outcomes

Primary Outcome Measures

Peak Value of I-FABP
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
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.

Full Information

First Posted
July 29, 2010
Last Updated
May 19, 2014
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01175317
Brief Title
Improvement of Fluid Balance in Patients Undergoing Surgery of the Colon and Rectum
Acronym
HOC
Official Title
Does Hemodynamic Optimization During and After Colorectal Surgery Result in Improved Intestinal Perfusion, Sustained Intestinal Barrier and Improved Postoperative Recovery?
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Carcinoma
Keywords
Hemodynamic optimization, Enhanced recovery after surgery, Goal-directed fluid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Goal-directed fluid optimization
Arm Type
Experimental
Arm Description
Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.
Arm Title
Regimen based on expertise anaesthesist
Arm Type
Other
Arm Description
Fluid regimen based on expertise anaesthesist
Intervention Type
Procedure
Intervention Name(s)
Goal-directed fluid optimization
Intervention Description
Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.
Intervention Type
Other
Intervention Name(s)
Regimen based on expertise anaesthesist
Intervention Description
Fluid regimen based on expertise anaesthesist
Primary Outcome Measure Information:
Title
Peak Value of I-FABP
Description
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.
Time Frame
1 hour postoperatively
Secondary Outcome Measure Information:
Title
Average Intraoperative CO2 Gap
Description
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.
Time Frame
Average intraoperative CO2 gap

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maarten F Von Meyenfeldt, MD, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Martijn Poeze, MD, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Geerard L Beets, MD, PhD
Organizational Affiliation
Maastricht University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Wim A Buurman, PhD
Organizational Affiliation
Maastricht University
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Maastricht
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229 HX
Country
Netherlands

12. IPD Sharing Statement

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

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