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

NCT01175317 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2014-06-19

Study results available
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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.

Conditions

  • Colorectal Carcinoma

Interventions

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

Sponsors & Collaborators

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Maarten F Von Meyenfeldt, MD, PhD · Maastricht University Medical Center

  • Martijn Poeze, MD, PhD · Maastricht University Medical Center

  • Geerard L Beets, MD, PhD · Maastricht University Hospital

  • Wim A Buurman, PhD · Maastricht University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01175317 on ClinicalTrials.gov