COMParison of Angiotensin Converting Enzyme Inhibitor managemenT Strategies Prior to Coronary Artery Bypass Surgery (the COMPACT Trial): a Pilot Randomized Controlled Registry Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Adherence to the study protocol
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
ACE/ARB Continuation
ACE/ARB will be continued up to and including the morning of surgery.
干预措施: ACE/ARB continuation (Drug)
ACE/ARB withdrawal
ACE/ARB will be discontinued medication 48 hours prior to surgery
干预措施: ACE/ARB withdrawal (Drug)
结局指标
主要结局
Adherence to the study protocol
时间窗: From randomization to surgery
Proportion of patients who adhere to ACE/ARB continuation or withdrawal as randomized
Feasibility of study enrollment
时间窗: 30 dasys
\>50% of eligible patients are successfully enrolled in the trial
Feasibility of Study
时间窗: 60 days
\>=95% completeness of outcomes
次要结局
- 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)
研究者
Sean van Diepen
Assistant Professor of Critical Care Medicine and Cardiology
University of Alberta
