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

Colorectal Carcinoma Clinical Trial

— HOC  

Official title:

Does Hemodynamic Optimization During and After Colorectal Surgery Result in Improved Intestinal Perfusion, Sustained Intestinal Barrier and Improved Postoperative Recovery?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01175317
• Other study ID #: MEC 09-2-089
• Status: Completed
• Phase: Phase 4
• First received: July 29, 2010
• Last updated: May 19, 2014
• Start date: April 2010
• Est. completion date: October 2013

Study information

• Verified date: May 2014
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Carcinoma

Intervention

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

Locations

Country	Name	City	State
Netherlands	University Hospital Maastricht	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 hour postoperatively	No
Secondary	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.	Average intraoperative CO2 gap	No