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OpenTrials
Completed

NCT Number: NCT01175317

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

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.

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Key information

Conditions

Colorectal Carcinoma Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Maastricht

Maastricht, Limburg, 6229 HX, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Goal-directed fluid optimization

Procedure

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

Other

Fluid regimen based on expertise anaesthesist

Primary outcomes

  1. Peak Value of I-FABP

    Time frame: 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 outcomes

  1. Average Intraoperative CO2 Gap

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

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

Acronym: HOC

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Aug 4, 2010
Registry last updated
Jun 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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