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

Phase 4

Completed

• Conditions: Colorectal Carcinoma
• Interventions: Procedure: Goal-directed fluid optimization; Other: Regimen based on expertise anaesthesist

• Registration Number: NCT01175317
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-07-29
• Study First Submitted QC: 2010-08-03
• Study First Posted: 2010-08-04
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Results First Submitted: 2013-11-05
• Status Verified: 2014-05
• Results First Submitted QC: 2014-05-19
• Last Update Submitted: 2014-05-19
• Results First Posted: 2014-06-19
• Last Update Posted: 2014-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Goal-directed fluid optimization	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	Regimen based on expertise anaesthesist	Fluid regimen based on expertise anaesthesist

Primary Outcome Measures

Name	Time	Method
Peak Value of I-FABP	1 hour postoperatively	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

Name	Time	Method
Average Intraoperative CO2 Gap	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.

Trial Locations

Locations (1)

University Hospital Maastricht; 🇳🇱 Maastricht, Limburg, Netherlands