Clinical trial NCT00563238: Beta-blocker Before Extubation
Official title: Use of Prophylactic Beta Blockade to Prevent Peri-extubation Cardiac Ischemia and Congestive Heart Failure
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Myocardial Ischemia
Keywords: Extubation
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2007-11-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: The rate of ischemia as judged by ST segment analysis in the 4h following extubation
timeFrame: 4 hours
Secondary outcomes:
measure: Rate-pressure product following extubation
timeFrame: 30min, 2h, 4h
measure: Troponin T elevations, the incidence of cardiogenic edema, and the rate of reintubation
timeFrame: 48h
measure: Pro-BNP levels
timeFrame: 30min
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: Gregory A Schmidt, MD
role: PRINCIPAL_INVESTIGATOR
References: