Status:
UNKNOWN
EPIC (Evaluating Perioperative Ischemia Reduction by Clonidine)
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Canadian Anesthesiologists' Society
Conditions:
Heart Disease
Eligibility:
All Genders
45+ years
Phase:
PHASE4
Brief Summary
In Canada 1 patient in 200 dies within 30 days of an operation. More than half of these deaths are the direct result of a heart related complication. This cause of death happens 4 times more often tha...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Age ≥ 45 years
- Current use of b-blocker therapy\>=30 days prior to surgery
- Undergoing non-cardiac surgery with an expected length of stay ≥ 48 hours for medical reasons
- Informed consent
- Undergoing major vascular surgery (excluding carotid endarterectomy, dialysis shunt, and vein stripping) OR
- Meet \>= 2of the following criteria:
- Coronary artery disease
- Congestive heart failure
- Stroke or transient ischemic attack
- Diabetes mellitus requiring oral hypoglycemic or insulin therapy
- Preoperative renal insufficiency (creatinine clearance below 60 mL/min)
- Peripheral vascular disease, as defined by any of the following: history of ischemic intermittent claudication or rest pain, history of revascularization procedure to legs, peripheral arterial obstruction of \>= 50% luminal diameter
- Age \>=70 years
- Intermediate-risk surgical procedure: intra-peritoneal, intra-thoracic, carotid endarterectomy, major orthopedic (hip, knee, spine) surgery, radical prostatectomy, or head-and-neck surgery
- Exclusion criteria: - if meets any of the following
- Prior adverse reaction to clonidine or a-2 agonists
- Current use of Clonidine or a-2 agonists
- Current congestive heart failure
- Only b-blocker taken by patient is sotalol
- Left ventricular ejection fraction \<=40%
- Systolic blood pressure \< = 90 mmHg
- Concomitant life-threatening disease likely to limit life expectancy to \<=30 days.
- Clinically significant aortic stenosis, defined as an aortic valve area \<=1.0 cm2 and/or peak trans-valvular pressure gradient \>= 25 mmHg
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT00335582
Start Date
June 1 2006
End Date
December 1 2009
Last Update
October 9 2009
Active Locations (1)
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1
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4