The BETTER Surgery Pilot Trial
- Conditions
- Perioperative outcomes
- Registration Number
- PACTR201609001780323
- Lead Sponsor
- Clinical Research Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 50
1. Age ¿ 45 years of age.
2. Undergoing intermediate or major non-cardiac surgery requiring an overnight stay in hospital.
3. With at least one of the following 4 criteria:
a. History of ischaemic heart disease
b. History of peripheral vascular disease
c. History of stroke; OR
d. Any 3 of the following 9 criteria:History of congestive cardiac failure, transient ischaemic attack, diabetes and currently on an oral hypoglycaemic agent or insulin, age¿70yrs, hypertension, serum creatinine >175 µmol/L (>2.0mg/dl), history of smoking within 2 years of surgery.
1. Patient refusal to participate.
2. Where clinical opinion suggests that surgery cannot be postponed for at least 2 weeks to allow for clinical response to a change in medical therapy.
3. Percutaneous coronary intervention within the last two weeks.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determine feasibility of recruiting patients undergoing noncardiac surgery to RCT of NP directed medical therapy prior to noncardiac surgery as compared to standard of care (defined as recruitment of 50 patients in one year).;Determine resources required to achieve recruitment, pre-operative randomization, and to conduct a full scale trial.;Assess compliance with trial protocol (defined as >90% complete follow up at 30 days postoperatively)
- Secondary Outcome Measures
Name Time Method Incidence of 30 day mortality, nonfatal myocardial infarction, nonfatal cardiac arrest, congestive cardiac failure and myocardial injury after noncardiac surgery