Back to resultsBeta-blocker Before Extubation
Primary Purpose
Myocardial Ischemia
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Metoprolol
Sponsored by
About this trial
This is an interventional prevention trial for Myocardial Ischemia focused on measuring Extubation
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
Sites / Locations
- University of Iowa Hospitals and Clinics
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Control
Metoprolol
Arm Description
Outcomes
Primary Outcome Measures
The rate of ischemia as judged by ST segment analysis in the 4h following extubation
Secondary Outcome Measures
Rate-pressure product following extubation
Troponin T elevations, the incidence of cardiogenic edema, and the rate of reintubation
Pro-BNP levels
Full Information
NCT ID
NCT00563238
First Posted
November 21, 2007
Last Updated
February 24, 2017
Sponsor
Gregory A. Schmidt
1. Study Identification
Unique Protocol Identification Number
NCT00563238
Brief Title
Beta-blocker Before Extubation
Official Title
Use of Prophylactic Beta Blockade to Prevent Peri-extubation Cardiac Ischemia and Congestive Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Withdrawn
Study Start Date
November 2007 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gregory A. Schmidt
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemia
Keywords
Extubation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Title
Metoprolol
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Metoprolol
Intervention Description
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 Measure Information:
Title
The rate of ischemia as judged by ST segment analysis in the 4h following extubation
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Rate-pressure product following extubation
Time Frame
30min, 2h, 4h
Title
Troponin T elevations, the incidence of cardiogenic edema, and the rate of reintubation
Time Frame
48h
Title
Pro-BNP levels
Time Frame
30min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory A Schmidt, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
12. IPD Sharing Statement
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Beta-blocker Before Extubation
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