Pilot - Peri-operative Beta Blockade

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Adrenergic Beta-Receptor Blockader Cardiomyopathies Cardiomyopathy, Post-surgical Cardiovascular Diseases Heart Diseases Troponin Levels

Age range

51 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metoprolol

Drug

Other names: Lopressor

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Novel Strategy For Perioperative Beta-Blocker Therapy - Pilot Study

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2017
First posted: Apr 21, 2016
Registry last updated: Jan 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed