Organ Protection With Sevoflurane Postconditioning | NCT00518908

Studies
Organ Protection With Sevoflurane Postconditioning

NCT00518908

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Jul 19, 2011Estimated

Enrollment

125Actual

Phase

Not Applicable

Conditions

Hepatectomy

Interventions

Sevoflurane

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Aug 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Aug 20, 2007

First Submission Date that Met QC Criteria

Aug 20, 2007

First Posted Date

Aug 21, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2011

Last Update Posted Date

Jul 19, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Organ protection, volatile anesthetics, postconditioning, hepatic surgery

Detailed Description

This study aims at the evaluation of a potential attenuation of ischemic-reperfusion injury in the liver with sevoflurane postconditioning upon reperfusion.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

125Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sevoflurane	Experimental	Sevoflurane for pharmacological postconditioning	Drug: Sevoflurane
Propofol	Experimental	Anesthesia maintenance with propofol instead of Sevoflurane postconditioning	Drug: Sevoflurane

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sevoflurane	Drug	3.2 Vol % for postconditioning	Propofol Sevoflurane

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
01 Studienregister MasterAdmins	UniversitaetsSpital Zuerich	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Zurich		Zurich			Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D015427	Reperfusion Injury

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D011183	Postoperative Complications
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077149	Sevoflurane

Ancestor Terms

ID	Term
D008738	Methyl Ethers
D004987	Ethers
D009930	Organic Chemicals
D006845	Hydrocarbons, Fluorinated

Browse Leaves

Not provided

Browse Branches

Not provided