Pilot - Peri-operative Beta Blockade

January 23, 2020 updated by: Washington University School of Medicine

Novel Strategy For Perioperative Beta-Blocker Therapy - Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Barnes-Jewish Hospital/Washington University in St. Louis School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

51 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment
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.
Drug: metoprolol
Other Names:
  • Lopressor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in hscTnI Values
Time Frame: Before surgery and Immediately after surgery (on the day of surgery)
Difference in hscTnI concentrations between preoperative clinic visit and day of surgery
Before surgery and Immediately after surgery (on the day of surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

April 14, 2016

First Submitted That Met QC Criteria

April 18, 2016

First Posted (Estimate)

April 21, 2016

Study Record Updates

Last Update Posted (Actual)

January 30, 2020

Last Update Submitted That Met QC Criteria

January 23, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201507010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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