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

This study has suspended participant recruitment.
(The final decision of the review of HES-containing solution shall be awaited.)
Sponsor:
Collaborator:
Fresenius Kabi
Information provided by (Responsible Party):
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT01303250
First received: February 22, 2011
Last updated: September 11, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Surgery, Colorectal
Drug: balanced 6% hydroxyethylstarch 130/0.4
Drug: balanced crystalloid
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Balanced 6 % HES 130/0.4 vs. Balanced Crystalloid-based Infusion in Patients Undergoing Colorectal Surgery

Resource links provided by NLM:


Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • Total amount of administered fluids [ Time Frame: intraoperatively ] [ Designated as safety issue: No ]
    Total amount of administered fluids intraoperatively that is necessary to keep patients optimal hemodynamic stabilized


Secondary Outcome Measures:
  • Incidence of surgery related complications [ Time Frame: day 28 and 90 postoperatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 170
Study Start Date: April 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01303250

Locations
Germany
University Hospital Muenster
Muenster, Germany, D-48149
Sponsors and Collaborators
University Hospital Muenster
Fresenius Kabi
Investigators
Principal Investigator: Hugo Van Aken, Prof. MD Department of Anesthesia and Intensive Care, University Hospital Muenster
  More Information

No publications provided

Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT01303250     History of Changes
Other Study ID Numbers: UKM09_0031, 2009-017595-25, 04-AnIt-09
Study First Received: February 22, 2011
Last Updated: September 11, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Muenster:
goal-directed fluid optimization
hemodynamic optimization
crystalloid
colloid

Additional relevant MeSH terms:
Hetastarch
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014