Beta-blocker Before Extubation

Study Overview
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Brief Summary
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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.

Official Title
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Use of Prophylactic Beta Blockade to Prevent Peri-extubation Cardiac Ischemia and Congestive Heart Failure

Conditions
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Myocardial Ischemia

Intervention / Treatment
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* Drug: Metoprolol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Active Comparator: Metoprolol<br> | Drug: Metoprolol<br>* Metoprolol administered intravenously in 2.5mg boluses until the resting heart rate falls by 10% from baseline to a maximum dose of 10mg, or until there is any apparent adverse reaction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of ischemia as judged by ST segment analysis in the 4h following extubation |  | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extubation