Organ Protection With Sevoflurane Postconditioning After... | NCT00924222

Studies
Organ Protection With Sevoflurane Postconditioning After Cardiac Surgery With Cardiopulmonary Bypass

NCT00924222

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Oct 12, 2011Estimated

Enrollment

120Actual

Phase

Not Applicable

Conditions

Cardiac On-pump Surgery

Interventions

Sevoflurane
Propofol

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

Oct 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

Oct 2007

Primary Completion Date

Nov 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Jun 17, 2009

First Submission Date that Met QC Criteria

Jun 17, 2009

First Posted Date

Jun 18, 2009Estimated

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

Oct 11, 2011

Last Update Posted Date

Oct 12, 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.

Sedation of patients on ICU after cardiac surgery with cardiopulmonary bypass with either propofol or sevoflurane. Evaluation of organ function and inflammatory mediators in the blood.

Detailed Description

Not provided

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

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sevoflurane	Experimental		Drug: Sevoflurane Drug: Propofol
Propofol	Experimental		Drug: Sevoflurane Drug: Propofol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sevoflurane	Drug	Sedation with sevoflurane	Propofol Sevoflurane

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Myocardial injury markers (myoglobin, creatine kinase, myocard specific creatine kinase, and troponin T)		Start and end of ICU stay

Secondary Outcomes

Measure	Description	Time Frame
Oxygenation index, postoperative pulmonary complications, ICU stay (days), length of hospitalisation		Start with surgery until end of hospitalisation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

CABG and/or heart valve surgery with CPB
Ejection fraction (EF) = 30%
Canadian Cardiovascular Society (CCS) classification = 3
Ages 18 to 90 years old

Exclusion criteria:

Pulmonary disease: forced expiratory volume in one second (FEV1) < 80%; FEV1/forced vital capacity (FVC) < 70%
Renal disease and/ or creatinine-clearance < 60 ml/min
Previous cardiac surgery
Emergency procedures
Postoperative intra aortic balloon pump (IABP) requirement
Myocardial infarction < 7d
Steroid treatment
Insulin-dependent diabetes
Pregnancy

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
		Zurich			Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23062276	Derived	Steurer MP, Steurer MA, Baulig W, Piegeler T, Schlapfer M, Spahn DR, Falk V, Dreessen P, Theusinger OM, Schmid ER, Schwartz D, Neff TA, Beck-Schimmer B. Late pharmacologic conditioning with volatile anesthetics after cardiac surgery. Crit Care. 2012 Oct 14;16(5):R191. doi: 10.1186/cc11676.

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