Pilot - Peri-operative Beta Blockade
Primary Purpose
Adrenergic Beta-Receptor Blockader, Troponin Levels, Cardiomyopathy, Post-surgical
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
metoprolol
Sponsored by
About this trial
This is an interventional prevention trial for Adrenergic Beta-Receptor Blockader
Eligibility Criteria
Inclusion Criteria:
- Age >50 years
- American Society of Anesthesiologists (ASA) risk status III-IV
- Revised Cardiac Risk Index ≥2
- β-blocker naïve (not having received β-blocker within 30 days prior to surgery)
- Previously diagnosed coronary artery disease (CAD) or at high risk for CAD:
- History of peripheral vascular disease, or
- Diabetes and currently on oral anti-diabetic drug or insulin therapy, or
- Chronic renal failure (eGFR <30 m/min)
- Major non-cardiac surgery under general anesthesia
Exclusion Criteria:
- History of stroke
- Heart rate <55bpm
- Heart failure
- Second or third degree AV block without pacemaker
- Active asthma or COPD
- Anemia [Hb<9g/dL]
- Allergy to beta-blockade drugs
- Hemodynamic instability
- Uncontrolled hemorrhage
- Unwilling or unable to give consent for participation
Sites / Locations
- Barnes-Jewish Hospital/Washington University in St. Louis School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
treatment
Arm Description
Postsurgical: 5mg metoprolol, IV, prior to extubation, every 5 minutes to achieve target heart rate of 65/min, up to 15mg; then 25mg metoprolol, oral, every 8 hours for 72 hours.
Outcomes
Primary Outcome Measures
Difference in hscTnI Values
Difference in hscTnI concentrations between preoperative clinic visit and day of surgery
Secondary Outcome Measures
Full Information
NCT ID
NCT02746575
First Posted
April 14, 2016
Last Updated
January 23, 2020
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02746575
Brief Title
Pilot - Peri-operative Beta Blockade
Official Title
Novel Strategy For Perioperative Beta-Blocker Therapy - Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Perioperative cardiac adverse events [heart injuries caused by general anesthesia and surgical procedures] are a significant public health issue, with more than 60,000 deaths per annum in patients having surgery for non-heart related issues. There are virtually no evidence-based medical strategies for effective prevention of these events. Preoperative drug treatment with beta blockade drugs used for high blood pressure, perioperative therapy with lipid lowering drugs such as statins, alpha-receptor agonists such as clonidine used for high blood pressure, and aspirin have all been investigated as potential mitigating treatments, but without positive clinical outcomes and, in some cases, creating more hemodynamic instabilities that result in heart injury. In light of this, investigators propose to evaluate the safety and efficacy of using increasing doses of beta blockade drugs immediately after surgery and to assess the value of high-sensitivity cardiac troponin level testing of the blood in predicting those patients who would benefit most from perioperative beta blocker therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adrenergic Beta-Receptor Blockader, Troponin Levels, Cardiomyopathy, Post-surgical
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
treatment
Arm Type
Experimental
Arm Description
Postsurgical: 5mg metoprolol, IV, prior to extubation, every 5 minutes to achieve target heart rate of 65/min, up to 15mg; then 25mg metoprolol, oral, every 8 hours for 72 hours.
Intervention Type
Drug
Intervention Name(s)
metoprolol
Other Intervention Name(s)
Lopressor
Primary Outcome Measure Information:
Title
Difference in hscTnI Values
Description
Difference in hscTnI concentrations between preoperative clinic visit and day of surgery
Time Frame
Before surgery and Immediately after surgery (on the day of surgery)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
51 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age >50 years
American Society of Anesthesiologists (ASA) risk status III-IV
Revised Cardiac Risk Index ≥2
β-blocker naïve (not having received β-blocker within 30 days prior to surgery)
Previously diagnosed coronary artery disease (CAD) or at high risk for CAD:
History of peripheral vascular disease, or
Diabetes and currently on oral anti-diabetic drug or insulin therapy, or
Chronic renal failure (eGFR <30 m/min)
Major non-cardiac surgery under general anesthesia
Exclusion Criteria:
History of stroke
Heart rate <55bpm
Heart failure
Second or third degree AV block without pacemaker
Active asthma or COPD
Anemia [Hb<9g/dL]
Allergy to beta-blockade drugs
Hemodynamic instability
Uncontrolled hemorrhage
Unwilling or unable to give consent for participation
Facility Information:
Facility Name
Barnes-Jewish Hospital/Washington University in St. Louis School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pilot - Peri-operative Beta Blockade
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