Pilot - Peri-operative Beta Blockade

NCT02746575 | Completed Phase 4 Results

• 1 other identifier: 201507010
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Adrenergic Beta-Receptor Blockader; Troponin Levels; Cardiomyopathy, Post-surgical

Outcome Measures

Primary Outcomes (1)

• Difference in hscTnI Values

  Difference in hscTnI concentrations between preoperative clinic visit and day of surgery

  Before surgery and Immediately after surgery (on the day of surgery)

Study Arms (1)

treatment

EXPERIMENTAL

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

Interventions

metoprolol DRUG

Also known as: Lopressor

treatment

Eligibility Criteria

• Age: 51 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Barnes-Jewish Hospital/Washington University in St. Louis School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Cardiomyopathies

Interventions

Metoprolol

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Results Point of Contact

• Title: Principal Investigator
• Organization: Washington University

7737022544

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2016
• First Posted: April 21, 2016
• Study Start: November 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2017
• Last Updated: January 30, 2020
• Results First Posted: January 30, 2020

Record last verified: 2020-01

Locations

US (1)