NCT00518908

Brief Summary

Organ protection, volatile anesthetics, postconditioning, hepatic surgery

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2008

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

August 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 21, 2007

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

July 19, 2011

Status Verified

July 1, 2011

Enrollment Period

2.6 years

First QC Date

August 20, 2007

Last Update Submit

July 18, 2011

Conditions

Hepatectomy

Keywords

Ischemia reperfusion injuryOrgan protection

Outcome Measures

Primary Outcomes (1)

  • Liver transaminase AST

    Peak value

    Postoperative phase until discharge

Secondary Outcomes (5)

  • ALT peak value

    Postoperative phase until discharge

  • Course of transaminases

    From the day before surgery, to 6 hours after surgery, up to postoperative day 7

  • Postoperative complications

    Postoperative phase until discharge

  • Length of hospital stay

    Postoperative phase until discharge

  • Need for prolonged intensive care unit stay (>24 hours)

    Postoperative phase until discharge

Study Arms (2)

Sevoflurane

EXPERIMENTAL

Sevoflurane for pharmacological postconditioning

Drug: Sevoflurane

Propofol

EXPERIMENTAL

Anesthesia maintenance with propofol instead of Sevoflurane postconditioning

Drug: Sevoflurane

Interventions

SevofluraneDRUG

3.2 Vol % for postconditioning

PropofolSevoflurane

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • non-german speakers
  • 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

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
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 20, 2007

First Posted

August 21, 2007

Study Start

January 1, 2008

Primary Completion

August 1, 2010

Study Completion

September 1, 2010

Last Updated

July 19, 2011

Record last verified: 2011-07

Locations

CH(1)