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Propofol Cardioprotection for Type II Diabetics

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00734383
First received: August 12, 2008
Last updated: July 11, 2012
Last verified: July 2012
History of Changes
  Purpose

The purpose of this study is to determine if an intravenous anesthetic with antioxidant properties will protect the heart of diabetic patients from injury while undergoing coronary bypass surgery.


Condition Intervention Phase
Myocardial Injury
 Drug: Propofol
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: PRO-TECT II: Propofol Cardioprotection for Type II Diabetics

Resource links provided by NLM:

Drug Information available for: Propofol
U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Perioperative Plasma 15 f2t isoprostane, a biologically active marker of oxidative stress [ Time Frame: 24 hours post operation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Perioperative (includes coronary sinus levels) plasma antioxidant concentration; ET-1, TNF alpha, Troponin I, peroxynitrite; gene and protein expression of eNOS and iNOS; hemodynamics [ Time Frame: 24 hours post operation ] [ Designated as safety issue: Yes ]

Enrollment: 137
Study Start Date: April 2005
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Propofol Cardioprotection
 Drug: Propofol
Propofol cardioprotection : Ten minutes prior to initiation of CPB, we will stop delivery of isoflurane, inject 1 mg/kg iv and then continuously infuse propofol at 120µg/kg/min IV until 15 min after release of the aortic cross clamp (reperfusion).
Experimental: 2
Volatile Anesthesia Preconditioning
 Drug: Propofol
Volatile Anesthetic preconditioning : Anesthesia will be maintained using an inspired concentration of isoflurane between 0.5-2% before, during, and after CPB, without administration of propofol. For ten minutes prior to the initiation of CPB we will deliver Isoflurane 2.5% end tidal then resume maintenance anesthesia as described.

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  Eligibility

Ages Eligible for Study:   19 Years to 29 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with and without Type II Diabetes Mellitus
  2. Hemodynamically Stable
  3. Non urgent Coronary Bypass Grafting utilizing Cardiopulmonary Bypass

Exclusion Criteria:

  1. Age less than 18 or greater than 80 years of age
  2. refuse informed consent
  3. Co-existing valvular heart disease
  4. Acute or evolving myocardial infarction
  5. hypersensitivity to propofol or formulation component
  6. Use of NSAIDs, Vitamins C or E within 5 to 7 days of surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00734383

Locations
Canada, British Columbia
UBC Dept of Anesthesiology, Pharmacology & Therapeutics, Vancouver Acute Hospital
Vancouver, British Columbia, Canada, V5Z 4E3
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: David M. Ansley, MD University of British Columbia
Study Director: Peter T. Choi, MD University of British Columbia
Study Director: David DY Chen, Ph.D University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00734383     History of Changes
Other Study ID Numbers: H04-70456
Study First Received: August 12, 2008
Last Updated: July 11, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
coronary artery bypass surgery
coronary artery bypass grafting
cardiopulmonary bypass
diabetes
 myocardial injury markers,
sex differences
cardiac anesthesia
inhalational anesthetics

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

ClinicalTrials.gov processed this record on May 19, 2013