COMParison of Angiotensin Converting Enzyme Inhibitor managemenT Strategies Prior to Coronary Artery Bypass Surgery (the COMPACT Trial): a Pilot Randomized Controlled Registry Study
Overview
- Phase
- Phase 2
- Intervention
- ACE/ARB continuation
- Conditions
- Coronary Artery Disease
- Sponsor
- University of Alberta
- Enrollment
- 126
- Locations
- 1
- Primary Endpoint
- Adherence to the study protocol
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
Coronary artery disease is a leading cause of death, hospitalization, and health care costs in developed nations. Coronary revascularization with coronary artery bypass graft (CABG) surgery improves the long term survival in patients with diabetes and multi-vessel disease. Angiotensin converting enzyme inhibitors (ACE) and angiotensin receptor blockers (ARB) reduce mortality and subsequent cardiac events in patients with coronary artery disease undergoing CABG surgery when initiated at least 4 weeks pre-operatively. Observational data have suggested that pre-operative ACE administration is associated with an increased risk of post-operative vasoplegic shock, acute kidney injury, and mortality; however, other studies have failed to confirm these findings and further suggested ACE are associated with a reduced risk of peri-operative myocardial infarction. A single trial of 40 CABG patients randomized to pre-operative ACE withdrawal or continuation reported that the withdrawal group required significantly fewer vasopressors during cardiopulmonary bypass but more intravenous vasodilators post-operatively to control hypertension. Hence, it remains unclear whether ACEs should be held or continued immediately prior to CABG surgery and a survey of cardiac surgeons suggests that current clinical practice is divided. This pilot study aims to establish the feasibility of the study design and to determine the frequency of clinical endpoints among patients who continue and discontinue ACE prior to cardiac surgery.
Investigators
Sean van Diepen
Assistant Professor of Critical Care Medicine and Cardiology
University of Alberta
Eligibility Criteria
Inclusion Criteria
- •Patients undergoing elective or urgent isolated CABG and/or valvular repari or replacement surgery
- •On an ACE or ARB for a minimum of 7 days
Exclusion Criteria
- •Emergency surgery
- •Pre-operative shock (defined as systolic blood pressure \< 90 mmHg, the need for any vasopressor or inotropic support, or a mechanical cardiac support device)
- •Severe uncontrolled pre-operative hypertension (defined as blood pressure ≥ 200 mmHg systolic or ≥120mmHg diastolic mmHG or the pre-operative need for intravenous anti-hypertensive agents)
- •ACE or ARB therapy \< 7 days
- •Any mineralocorticoid receptor antagonist therapy.
Arms & Interventions
ACE/ARB Continuation
ACE/ARB will be continued up to and including the morning of surgery.
Intervention: ACE/ARB continuation
ACE/ARB withdrawal
ACE/ARB will be discontinued medication 48 hours prior to surgery
Intervention: ACE/ARB withdrawal
Outcomes
Primary Outcomes
Adherence to the study protocol
Time Frame: From randomization to surgery
Proportion of patients who adhere to ACE/ARB continuation or withdrawal as randomized
Feasibility of study enrollment
Time Frame: 30 dasys
\>50% of eligible patients are successfully enrolled in the trial
Feasibility of Study
Time Frame: 60 days
\>=95% completeness of outcomes
Secondary Outcomes
- Vasodilator use(7 days)
- Incidence of post operative Shock(3 hours)
- Duration of Shock(7 days)
- Post operative intravenous anti-hypertensive use(7 days)
- Feasibility of the Study(30 days)
- Change in renal function(7 days)
- Stroke(30 days)
- Post-operative acute kidney injury(7 days)
- Vasopressors use(7 days)
- Duration of intravenous vasodilator use(7 days)
- Incidence of vasoplegic shock(4 hours)
- Pre-operative heart failure deterioration(48 hours)
- Initiation of renal replacement therapy(7 days)
- Peak post-operative troponin(72 hours)
- In hospital Mortality(Participants will be followed for the duration of hospital stay, an expected average of 7 days)