Organ Protection With Sevoflurane Postconditioning After Cardiac Surgery With Cardiopulmonary Bypass

NCT ID: NCT00924222

Last Updated: 2011-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-12-31

Brief Summary

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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

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Conditions

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Cardiac On-pump Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sevoflurane

Group Type EXPERIMENTAL

Sevoflurane

Intervention Type DRUG

Sedation with sevoflurane

Propofol

Intervention Type DRUG

Sedation on intensive care unit with propofol

Propofol

Group Type EXPERIMENTAL

Sevoflurane

Intervention Type DRUG

Sedation with sevoflurane

Propofol

Intervention Type DRUG

Sedation on intensive care unit with propofol

Interventions

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Sevoflurane

Sedation with sevoflurane

Intervention Type DRUG

Propofol

Sedation on intensive care unit with propofol

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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01 Studienregister MasterAdmins

Role: STUDY_DIRECTOR

UniversitaetsSpital Zuerich

Locations

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Zurich, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 23062276 (View on PubMed)

Other Identifiers

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IFA-5-2007

Identifier Type: -

Identifier Source: org_study_id