Propofol Cardioprotection for Type II Diabetics
PRO-TECT II: Propofol Cardioprotection for Type II Diabetics
1 other identifier
interventional
137
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2005
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 12, 2008
CompletedFirst Posted
Study publicly available on registry
August 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedJuly 13, 2012
July 1, 2012
7.1 years
August 12, 2008
July 11, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Perioperative Plasma 15 f2t isoprostane, a biologically active marker of oxidative stress
24 hours post operation
Secondary Outcomes (1)
Perioperative (includes coronary sinus levels) plasma antioxidant concentration; ET-1, TNF alpha, Troponin I, peroxynitrite; gene and protein expression of eNOS and iNOS; hemodynamics
24 hours post operation
Study Arms (2)
1
EXPERIMENTALPropofol Cardioprotection
2
EXPERIMENTALVolatile Anesthesia Preconditioning
Interventions
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).
Eligibility Criteria
You may qualify if:
- Patients with and without Type II Diabetes Mellitus
- Hemodynamically Stable
- Non urgent Coronary Bypass Grafting utilizing Cardiopulmonary Bypass
You may not qualify if:
- Age less than 18 or greater than 80 years of age
- refuse informed consent
- Co-existing valvular heart disease
- Acute or evolving myocardial infarction
- hypersensitivity to propofol or formulation component
- Use of NSAIDs, Vitamins C or E within 5 to 7 days of surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UBC Dept of Anesthesiology, Pharmacology & Therapeutics, Vancouver Acute Hospital
Vancouver, British Columbia, V5Z 4E3, Canada
Related Publications (1)
Ansley DM, Raedschelders K, Choi PT, Wang B, Cook RC, Chen DD. Propofol cardioprotection for on-pump aortocoronary bypass surgery in patients with type 2 diabetes mellitus (PRO-TECT II): a phase 2 randomized-controlled trial. Can J Anaesth. 2016 Apr;63(4):442-53. doi: 10.1007/s12630-015-0580-z. Epub 2015 Dec 31.
PMID: 26721648DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2008
First Posted
August 14, 2008
Study Start
April 1, 2005
Primary Completion
May 1, 2012
Study Completion
June 1, 2012
Last Updated
July 13, 2012
Record last verified: 2012-07