NCT00563238

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

February 28, 2017

Status Verified

February 1, 2017

Enrollment Period

2.1 years

First QC Date

November 21, 2007

Last Update Submit

February 24, 2017

Conditions

Myocardial Ischemia

Keywords

Extubation

Outcome Measures

Primary Outcomes (1)

  • The rate of ischemia as judged by ST segment analysis in the 4h following extubation

    4 hours

Secondary Outcomes (3)

  • Rate-pressure product following extubation

    30min, 2h, 4h

  • Troponin T elevations, the incidence of cardiogenic edema, and the rate of reintubation

    48h

  • Pro-BNP levels

    30min

Study Arms (2)

Control

NO INTERVENTION

Metoprolol

ACTIVE COMPARATOR
Drug: Metoprolol

Interventions

MetoprololDRUG

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.

Metoprolol

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Metoprolol

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAmines

Study Officials

  • Gregory A Schmidt, MD

    University of Iowa

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 21, 2007

First Posted

November 26, 2007

Study Start

November 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

February 28, 2017

Record last verified: 2017-02

Locations

US(1)