Role of Volatile Anesthetics for Hepatic Protection
Primary Purpose
Reperfusion Injury
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Sevoflurane
Sponsored by
About this trial
This is an interventional prevention trial for Reperfusion Injury focused on measuring Surgery with Pringle maneuver needed for liver resection
Eligibility Criteria
Inclusion Criteria:
- Older than 18 years of age
- Patients undergoing liver resection (benign or malignant tumors)
Exclusion Criteria:
- Laparoscopic liver resection coagulopathy (platelets < 50,000/ml, Quick < 50%)
- Liver cirrhosis
Sites / Locations
- University Hospital of Zurich
Outcomes
Primary Outcome Measures
Blood levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT)
Secondary Outcome Measures
Full Information
NCT ID
NCT00516711
First Posted
August 14, 2007
Last Updated
September 14, 2010
Sponsor
University of Zurich
1. Study Identification
Unique Protocol Identification Number
NCT00516711
Brief Title
Role of Volatile Anesthetics for Hepatic Protection
Official Title
Role of Volatile Anesthetics for Hepatic Protection in Ischemia-reperfusion
Study Type
Interventional
2. Study Status
Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Zurich
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to evaluate the attenuation of ischemic-reperfusion injury in the liver after sevoflurane preconditioning. In the presence of sevoflurane, an attenuation of liver injury is hypothesized (diminished increase of liver enzymes, reduced production of inflammatory mediators).
Detailed Description
Organ protection; preconditioning; volatile anesthetics; ischemia reperfusion
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reperfusion Injury
Keywords
Surgery with Pringle maneuver needed for liver resection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Primary Outcome Measure Information:
Title
Blood levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Older than 18 years of age
Patients undergoing liver resection (benign or malignant tumors)
Exclusion Criteria:
Laparoscopic liver resection coagulopathy (platelets < 50,000/ml, Quick < 50%)
Liver cirrhosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
01 Studienregister MasterAdmins
Organizational Affiliation
UniversitaetsSpital Zuerich
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital of Zurich
City
Zurich
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
19092335
Citation
Beck-Schimmer B, Breitenstein S, Urech S, De Conno E, Wittlinger M, Puhan M, Jochum W, Spahn DR, Graf R, Clavien PA. A randomized controlled trial on pharmacological preconditioning in liver surgery using a volatile anesthetic. Ann Surg. 2008 Dec;248(6):909-18. doi: 10.1097/SLA.0b013e31818f3dda.
Results Reference
derived
Learn more about this trial
Role of Volatile Anesthetics for Hepatic Protection
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