Beta-blocker Before Extubation

NCT ID: NCT00563238

Last Updated: 2017-02-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2009-12-31

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.

Conditions

Myocardial Ischemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Metoprolol

Group Type: ACTIVE_COMPARATOR

Metoprolol

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gregory A. Schmidt

OTHER

Sponsor Role: lead

Responsible Party

Gregory A. Schmidt

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gregory A Schmidt, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Countries

United States

Other Identifiers

200708711

Identifier Type: -

Identifier Source: org_study_id