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Propofol Cardioprotection for Type II Diabetics

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00734383
First Posted: August 14, 2008
Last Update Posted: July 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of British Columbia
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: PRO-TECT II: Propofol Cardioprotection for Type II Diabetics

Resource links provided by NLM:


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 ]

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 ]

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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00734383     History of Changes
Other Study ID Numbers: H04-70456
First Submitted: August 12, 2008
First Posted: August 14, 2008
Last Update Posted: July 13, 2012
Last Verified: July 2012

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:
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics