Beta-Blocker Before Extubation | RxWiki

Beta-Blocker Before Extubation

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Myocardial Ischemia
Intervention	Drug: Metoprolol
Phase	N/A
Sponsor	University of Iowa
Responsible Party	University of Iowa
ClinicalTrials.gov Identifier	NCT00563238
First Received	November 21, 2007
Last Updated	July 22, 2008
Last verified	July 2008

Tracking Information[ + expand ][ + ]

First Received Date	November 21, 2007
Last Updated Date	July 22, 2008
Start Date	November 2007
Estimated Primary Completion Date	December 2009
Current Primary Outcome Measures	The rate of ischemia as judged by ST segment analysis in the 4h following extubation [Time Frame: 4 hours] [Designated as safety issue: No]
Current Secondary Outcome Measures	Rate-pressure product following extubation [Time Frame: 30min, 2h, 4h] [Designated as safety issue: No] Troponin T elevations, the incidence of cardiogenic edema, and the rate of reintubation [Time Frame: 48h] [Designated as safety issue: No] Pro-BNP levels [Time Frame: 30min] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	Beta-Blocker Before Extubation
Official Title	Use of Prophylactic Beta Blockade to Prevent Peri-Extubation Cardiac Ischemia and Congestive Heart Failure
Brief Summary	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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	N/A
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Condition	Myocardial Ischemia
Intervention	Drug: Metoprolol 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.
Study Arm (s)	No Intervention: Control Active Comparator: Metoprolol

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	50
Estimated Completion Date	December 2009
Estimated Primary Completion Date	December 2009
Eligibility Criteria	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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Gregory A Schmidt, MD 3193846746 gregory-a-schmidt@uiowa.edu
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00563238
Other Study ID Numbers	200708711
Has Data Monitoring Committee	No
Information Provided By	University of Iowa
Study Sponsor	University of Iowa
Collaborators	Not Provided
Investigators	Principal Investigator: Gregory A Schmidt, MD University of Iowa
Verification Date	July 2008

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