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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
University of Zurich
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
August 14, 2007
Last Updated
September 14, 2010
Sponsor
University of Zurich
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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

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Role of Volatile Anesthetics for Hepatic Protection

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