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

This study has been terminated.
(The final decision of the review of HES-containing solution shall be awaited.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01303250
First Posted: February 24, 2011
Last Update Posted: December 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fresenius Kabi
Information provided by (Responsible Party):
University Hospital Muenster
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]
    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 ]

Enrollment: 31
Study Start Date: April 2011
Study Completion Date: April 2015
Primary Completion Date: April 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT01303250     History of Changes
Other Study ID Numbers: UKM09_0031
2009-017595-25 ( EudraCT Number )
04-AnIt-09 ( Other Identifier: Department of Anesthesiology, University Hospital Muenster )
First Submitted: February 22, 2011
First Posted: February 24, 2011
Last Update Posted: December 18, 2015
Last Verified: December 2015

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