PRO-TECT II: Propofol cardioprotection for type II diabetics

Not Applicable

Completed

Conditions: Cardioprotection for type II diabetics
Nutritional, Metabolic, Endocrine
Non-insulin-dependent diabetes mellitus

Registration Number: ISRCTN70879185

Lead Sponsor: niversity of British Columbia (Canada)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 144

Inclusion Criteria

1. Adult patients aged 18 - 80 years, either sex
2. Undergoing primary coronary artery bypass graft (CABG) surgery requiring cardiopulmonary bypass (CPB) at the Vancouver General Hospital
3. Require revascularisation of three or more coronary arteries with an anticipated aortic cross-clamp time of at least 60 minutes
4. Have a pre-operative systolic blood pressure above 90 mmHg in the absence of inotropic or mechanical support

Exclusion Criteria

1. Type I diabetes mellitus (defined as an established history and diagnosis of diabetes mellitus requiring insulin therapy from the time of diagnosis)
2. Co-existing valvular heart disease (moderate to severe aortic stenosis or mitral regurgitation)
3. Acute or evolving myocardial infarction
4. History of hypersensitivity to propofol or any of its formulation components
5. Taking non-steroidal anti-inflammatory drugs, vitamin C, or vitamin E within five days of surgery

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peri-operative plasma 15 f2t isoprostane, a biologically active marker of oxidative stress. Timeframe: 24 hours post-operation.

Secondary Outcome Measures

Name	Time	Method
Biochemical outcomes:<br>1. Plasma total antioxidant concentration<br>2. Systemic and coronary sinus levels of troponin I, ET-1, TNF-a, and peroxynitrite formation in blood<br>3. Gene and protein expression of inducible NOS (iNOS) and eNOS<br>4. Protein expression of Akt and its activation<br>5. Evidence of superoxide formation in atrial tissue<br><br>Clinical outcomes:<br>6. Incidence rate of low cardiac output syndrome during the first 6 hours after surgery<br>7. Incidence rate of inotropic support or intra-aortic balloon counterpulsation required for greater than 30 minutes duration to treat low cardiac output syndrome<br>8. Intensive care unit and hospital lengths of stay