Beta-blocker Before Extubation

Myocardial Ischemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00563238
• Other study ID #: 200708711
• Status: Withdrawn
• Phase: N/A
• First received: November 21, 2007
• Last updated: February 24, 2017
• Start date: November 2007
• Est. completion date: December 2009

Study information

• Verified date: February 2017
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Ischemia
• 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.

Locations

Country	Name	City	State
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Gregory A. Schmidt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of ischemia as judged by ST segment analysis in the 4h following extubation		4 hours
Secondary	Rate-pressure product following extubation		30min, 2h, 4h
Secondary	Troponin T elevations, the incidence of cardiogenic edema, and the rate of reintubation		48h
Secondary	Pro-BNP levels		30min