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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
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Adrenergic Beta-Receptor Blockader

Eligibility Criteria

51 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
April 14, 2016
Last Updated
January 23, 2020
Sponsor
Washington University School of Medicine
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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

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Pilot - Peri-operative Beta Blockade

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