Text Size

Organ Protection With Sevoflurane Postconditioning After Cardiac Surgery With Cardiopulmonary Bypass

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT00924222
First received: June 17, 2009
Last updated: October 11, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition Intervention
Cardiac On-pump Surgery
 Drug: Sevoflurane
Drug: Propofol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Myocardial injury markers (myoglobin, creatine kinase, myocard specific creatine kinase, and troponin T) [ Time Frame: Start and end of ICU stay ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Oxygenation index, postoperative pulmonary complications, ICU stay (days), length of hospitalisation [ Time Frame: Start with surgery until end of hospitalisation ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: October 2007
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sevoflurane Drug: Sevoflurane
Sedation with sevoflurane
Drug: Propofol
Sedation on intensive care unit with propofol
Experimental: Propofol Drug: Sevoflurane
Sedation with sevoflurane
Drug: Propofol
Sedation on intensive care unit with propofol

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00924222

Locations
Switzerland
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT00924222     History of Changes
Other Study ID Numbers: IFA-5-2007
Study First Received: June 17, 2009
Last Updated: October 11, 2011
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Propofol
Sevoflurane
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation

ClinicalTrials.gov processed this record on May 22, 2013