Beta-blocker Before Extubation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00563238
Recruitment Status : Withdrawn
First Posted : November 26, 2007
Last Update Posted : February 28, 2017
Information provided by (Responsible Party):
Gregory A. Schmidt, University of Iowa

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.

Condition or disease Intervention/treatment Phase
Myocardial Ischemia Drug: Metoprolol Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Use of Prophylactic Beta Blockade to Prevent Peri-extubation Cardiac Ischemia and Congestive Heart Failure
Study Start Date : November 2007
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Control
Active Comparator: Metoprolol 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.

Primary Outcome Measures :
  1. The rate of ischemia as judged by ST segment analysis in the 4h following extubation [ Time Frame: 4 hours ]

Secondary Outcome Measures :
  1. Rate-pressure product following extubation [ Time Frame: 30min, 2h, 4h ]
  2. Troponin T elevations, the incidence of cardiogenic edema, and the rate of reintubation [ Time Frame: 48h ]
  3. Pro-BNP levels [ Time Frame: 30min ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00563238

United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Gregory A. Schmidt
Principal Investigator: Gregory A Schmidt, MD University of Iowa

Responsible Party: Gregory A. Schmidt, Professor, University of Iowa Identifier: NCT00563238     History of Changes
Other Study ID Numbers: 200708711
First Posted: November 26, 2007    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2017

Keywords provided by Gregory A. Schmidt, University of Iowa:

Additional relevant MeSH terms:
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases
Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action