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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Hydroxyethyl Starch Derivatives
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014