Organ Protection With Sevoflurane Postconditioning

July 18, 2011 updated by: University of Zurich

Role of Volatile Anesthetics for Hepatic Protection in Ischemia-reperfusion: Postconditioning

Organ protection, volatile anesthetics, postconditioning, hepatic surgery

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland
        • University Hospital of Zürich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver transaminase AST
Time Frame: Postoperative phase until discharge
Peak value
Postoperative phase until discharge

Secondary Outcome Measures

Outcome Measure
Time Frame
ALT peak value
Time Frame: Postoperative phase until discharge
Postoperative phase until discharge
Course of transaminases
Time Frame: From the day before surgery, to 6 hours after surgery, up to postoperative day 7
From the day before surgery, to 6 hours after surgery, up to postoperative day 7
Postoperative complications
Time Frame: Postoperative phase until discharge
Postoperative phase until discharge
Length of hospital stay
Time Frame: Postoperative phase until discharge
Postoperative phase until discharge
Need for prolonged intensive care unit stay (>24 hours)
Time Frame: Postoperative phase until discharge
Postoperative phase until discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

August 20, 2007

First Submitted That Met QC Criteria

August 20, 2007

First Posted (Estimate)

August 21, 2007

Study Record Updates

Last Update Posted (Estimate)

July 19, 2011

Last Update Submitted That Met QC Criteria

July 18, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • StV 34-2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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