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

November 21, 2007
July 22, 2008
November 2007
December 2009   (final data collection date for primary outcome measure)
The rate of ischemia as judged by ST segment analysis in the 4h following extubation [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
The rate of ischemia as judged by ST segment analysis in the 4h following extubation [ Time Frame: 4 hours ]
Complete list of historical versions of study NCT00563238 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Rate-pressure product following extubation [ Time Frame: 30min, 2h, 4h ]
  • Troponin T elevations, the incidence of cardiogenic edema, and the rate of reintubation [ Time Frame: 48h ]
  • Pro-BNP levels [ Time Frame: 30min ]
Not Provided
Not Provided
 
Beta-Blocker Before Extubation
Use of Prophylactic Beta Blockade to Prevent Peri-Extubation Cardiac Ischemia and Congestive Heart Failure

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Myocardial Ischemia
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.
  • No Intervention: Control
  • Active Comparator: Metoprolol
    Intervention: Drug: Metoprolol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Gregory A Schmidt, MD 3193846746 gregory-a-schmidt@uiowa.edu
United States
 
NCT00563238
200708711
No
Gregory A. Schmidt, University of Iowa
University of Iowa
Not Provided
Principal Investigator: Gregory A Schmidt, MD University of Iowa
University of Iowa
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP