Use of Prophylactic Beta Blockade to Prevent Peri-extubation Cardiac Ischemia and Congestive Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- The rate of ischemia as judged by ST segment analysis in the 4h following extubation
研究概览
简要总结
Silent myocardial ischemia is known to occur in the general medical intensive care unit population immediately following tracheal extubation. We believe these patients are at risk for primary cardiac events in the 4 hours immediately following extubation. Metoprolol is a selective beta-1 antagonist, with little to no beta-2 activity at low and moderate doses. The cardioprotective effects of beta blockade have been well documented in randomized controlled trials. In patients undergoing extubation, prophylactic use of intravenous metoprolol may reduce post-extubation ischemia events as well as precursors of cardiogenic pulmonary edema (atrial and ventricular wall tension). Our primary hypothesis is that prophylactic metoprolol (titrated to reduce resting heart rate by at least 10%) prior to tracheal extubation will reduce the rate of ischemia as judged by ST segment analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult medical or cardiac intensive care unit patients on mechanical ventilation who have known coronary artery disease or have at least 2 of the following risk factors for coronary artery disease:
- •Cigarette smoking
- •Hypertension (BP 140/90 or antihypertensive medication)
- •Low HDL-cholesterol (HDL-C) (<40 mg/dL [1.03 mmol/L])
- •Family history of premature CHD (in male first degree relatives <55 years, in female first degree relative <65 years)
- •Age (men 45 years, women 55 years)
- •Diabetes mellitus
- •Symptomatic carotid artery disease
- •Peripheral arterial disease
- •Abdominal aortic aneurysm
排除标准
- •Arterial hypotension, defined as mean arterial pressure < 60 mmHg or requiring any intravenous vasoactive medication.
- •The presence of known reactive airway disease.
- •Resting heart rate of <60 in the period prior to tracheal extubation..
- •The presence of decompensated congestive heart failure, defined as requiring continuous infusion of an inotropic agent.
- •Known hypersensitivity to beta-blockers or any other contraindication to their use.
- •Subjects younger than 18 years of age.
- •Inability to obtain consent from the subject or the subjects authorized representative.
- •Pregnancy
- •Digoxin therapy
- •Current therapy with a beta-blocker
研究组 & 干预措施
Metoprolol
干预措施: Metoprolol (Drug)
结局指标
主要结局
The rate of ischemia as judged by ST segment analysis in the 4h following extubation
时间窗: 4 hours
次要结局
- Rate-pressure product following extubation(30min, 2h, 4h)
- Troponin T elevations, the incidence of cardiogenic edema, and the rate of reintubation(48h)
- Pro-BNP levels(30min)
研究者
Gregory A. Schmidt
Professor
University of Iowa