Perioperative Colloid vs Crystalloid in Patients Undergoing Colorectal Surgery (KoKris)

December 17, 2015 updated by: University Hospital Muenster

Balanced 6 % HES 130/0.4 vs. Balanced Crystalloid-based Infusion in Patients Undergoing Colorectal Surgery

The primary purpose of this study is to determine the effect of a balanced 6%hydroxyethyl starch 130/0.4 vs. a balanced crystalloid in colorectal surgery. The intraoperative fluid management will be given to optimize the stroke volume variation <= 12%.

The investigators hypothesize that patients in the intervention group will need less fluid administration be optimal hemodynamic stabilized.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Muenster, Germany, D-48149
        • University Hospital Muenster

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients undergoing elective colorectal surgery
  • minimum age 18 years
  • informed consent

Exclusion Criteria:

  • patients with severe cardiomyopathy or severe heart failure
  • history of coagulation disorders
  • intracranial hemorrhage
  • patients with severe cardiovascular or respiratory disorders
  • renal insufficiency
  • severe liver diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group 1
A balanced hydroxyethyl starch 130/0.4 will be used
Drug: balanced 6% hydroxyethylstarch 130/0.4
Fluid administration and optimization based on cardiac output findings during surgery.
ACTIVE_COMPARATOR: Group 2
A balanced crystalloid will be used
Drug: balanced crystalloid
Fluid administration and optimization based on cardiac output findings during surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total amount of administered fluids
Time Frame: intraoperatively
Total amount of administered fluids intraoperatively that is necessary to keep patients optimal hemodynamic stabilized
intraoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of surgery related complications
Time Frame: day 28 and 90 postoperatively
day 28 and 90 postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Muenster

Collaborators

Fresenius Kabi

Investigators

  • Principal Investigator: Hugo Van Aken, Prof. MD, Department of Anesthesia and Intensive Care, University Hospital Muenster

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (ACTUAL)

April 1, 2015

Study Completion (ACTUAL)

April 1, 2015

Study Registration Dates

First Submitted

February 22, 2011

First Submitted That Met QC Criteria

February 22, 2011

First Posted (ESTIMATE)

February 24, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

December 18, 2015

Last Update Submitted That Met QC Criteria

December 17, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UKM09_0031
  • 2009-017595-25 (EUDRACT_NUMBER)
  • 04-AnIt-09 (OTHER: Department of Anesthesiology, University Hospital Muenster)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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