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Beta-Blocker Before Extubation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by University of Iowa.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT00563238
First received: November 21, 2007
Last updated: July 22, 2008
Last verified: July 2008
History of Changes
  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 Intervention
Myocardial Ischemia
 Drug: Metoprolol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Use of Prophylactic Beta Blockade to Prevent Peri-Extubation Cardiac Ischemia and Congestive Heart Failure

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Iowa:

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 ]

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 ]

Estimated Enrollment: 50
Study Start Date: November 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00563238

Contacts
Contact: Gregory A Schmidt, MD 3193846746 gregory-a-schmidt@uiowa.edu

Locations
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Principal Investigator: Gregory A Schmidt, MD            
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Gregory A Schmidt, MD University of Iowa
  More Information

No publications provided

Responsible Party: Gregory A. Schmidt, University of Iowa
ClinicalTrials.gov Identifier: NCT00563238     History of Changes
Other Study ID Numbers: 200708711
Study First Received: November 21, 2007
Last Updated: July 22, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
Extubation

Additional relevant MeSH terms:
Myocardial Ischemia
Coronary Artery Disease
Heart Failure
Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes
Metoprolol
Metoprolol succinate
Anti-Arrhythmia Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Sympatholytics
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

ClinicalTrials.gov processed this record on May 22, 2013