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临床试验/NCT02096406
NCT02096406已完成2 期

COMParison of Angiotensin Converting Enzyme Inhibitor managemenT Strategies Prior to Coronary Artery Bypass Surgery (the COMPACT Trial): a Pilot Randomized Controlled Registry Study

University of Alberta1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2014年4月最近更新:
适应症
干预措施
相关药物

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

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

Other

ACE/ARB will be continued up to and including the morning of surgery.

干预措施: ACE/ARB continuation (Drug)

ACE/ARB withdrawal

Other

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sean van Diepen

Assistant Professor of Critical Care Medicine and Cardiology

University of Alberta

研究点 (1)

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