NCT00516711

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 15, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

September 15, 2010

Status Verified

August 1, 2007

Enrollment Period

1.8 years

First QC Date

August 14, 2007

Last Update Submit

September 14, 2010

Conditions

Reperfusion Injury

Keywords

Surgery with Pringle maneuver needed for liver resection

Outcome Measures

Primary Outcomes (1)

  • Blood levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT)

Interventions

SevofluraneDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Older than 18 years of age
  • Patients undergoing liver resection (benign or malignant tumors)

You may not qualify if:

  • Laparoscopic liver resection coagulopathy (platelets \< 50,000/ml, Quick \< 50%)
  • Liver cirrhosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Zurich

Zurich, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 19092335DERIVED

MeSH Terms

Conditions

Reperfusion Injury

Interventions

Sevoflurane

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • 01 Studienregister MasterAdmins

    UniversitaetsSpital Zuerich

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 14, 2007

First Posted

August 15, 2007

Study Start

March 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

September 15, 2010

Record last verified: 2007-08

Locations

CH(1)