Beta-Blocker Before Extubation
Information source: University of Iowa
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Myocardial Ischemia
Intervention: Metoprolol (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of Iowa Official(s) and/or principal investigator(s):
Gregory A Schmidt, MD, Principal Investigator, Affiliation: University of Iowa
Overall contact:
Gregory A Schmidt, MD, Phone: 3193846746, Email: gregory-a-schmidt@uiowa.edu
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.
Clinical Details
Official title: Use of Prophylactic Beta Blockade to Prevent Peri-Extubation Cardiac Ischemia and Congestive Heart Failure
Study design: Prevention, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
Primary outcome: The rate of ischemia as judged by ST segment analysis in the 4h following extubation
Secondary outcome: Rate-pressure product following extubationTroponin T elevations, the incidence of cardiogenic edema, and the rate of reintubation Pro-BNP levels
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Gregory A Schmidt, MD, Phone: 3193846746, Email: gregory-a-schmidt@uiowa.edu
University of Iowa Hospitals and Clinics, Iowa City, Iowa 52242, United States; Recruiting
Gregory A Schmidt, MD, Principal Investigator
Additional Information
Starting date: November 2007
Ending date: December 2009
Last updated: July 22, 2008
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