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Organ Protection With Sevoflurane Postconditioning

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ClinicalTrials.gov Identifier: NCT00518908
Recruitment Status : Completed
First Posted : August 21, 2007
Last Update Posted : July 19, 2011
Sponsor:
Information provided by:
University of Zurich

Brief Summary:
Organ protection, volatile anesthetics, postconditioning, hepatic surgery

Condition or disease Intervention/treatment Phase
Hepatectomy Drug: Sevoflurane Not Applicable

Detailed Description:
This study aims at the evaluation of a potential attenuation of ischemic-reperfusion injury in the liver with sevoflurane postconditioning upon reperfusion.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Role of Volatile Anesthetics for Hepatic Protection in Ischemia-reperfusion: Postconditioning
Study Start Date : January 2008
Actual Primary Completion Date : August 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Sevoflurane
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Sevoflurane
Sevoflurane for pharmacological postconditioning
Drug: Sevoflurane
3.2 Vol % for postconditioning
Experimental: Propofol
Anesthesia maintenance with propofol instead of Sevoflurane postconditioning
Drug: Sevoflurane
3.2 Vol % for postconditioning



Primary Outcome Measures :
  1. Liver transaminase AST [ Time Frame: Postoperative phase until discharge ]
    Peak value


Secondary Outcome Measures :
  1. ALT peak value [ Time Frame: Postoperative phase until discharge ]
  2. Course of transaminases [ Time Frame: From the day before surgery, to 6 hours after surgery, up to postoperative day 7 ]
  3. Postoperative complications [ Time Frame: Postoperative phase until discharge ]
  4. Length of hospital stay [ Time Frame: Postoperative phase until discharge ]
  5. Need for prolonged intensive care unit stay (>24 hours) [ Time Frame: Postoperative phase until discharge ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • older than 18 years
  • patients undergoing liver resection (benign or malignant tumors)

Exclusion criteria:

  • non-german speakers
  • laparoscopic liver resection
  • coagulopathy (platelets < 50'000/ml, Quick < 50%)
  • liver cirrhosis

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): NCT00518908


Locations
Switzerland
University Hospital of Zurich
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich

Responsible Party: BECK SCHIMMER Beatrice, Professor, University Hospital Zurich, Department of Anesthesiology
ClinicalTrials.gov Identifier: NCT00518908     History of Changes
Other Study ID Numbers: StV 34-2007
First Posted: August 21, 2007    Key Record Dates
Last Update Posted: July 19, 2011
Last Verified: July 2011

Keywords provided by University of Zurich:
Ischemia reperfusion injury
Organ protection

Additional relevant MeSH terms:
Sevoflurane
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs