Pilot - Peri-operative Beta Blockade
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 51 - Any |
| Updated: | 6/18/2016 |
| Start Date: | November 2015 |
| End Date: | April 2017 |
| Contact: | Peter Nagele, MD |
| Email: | nagelep@anest.wustl.edu |
| Phone: | 314-362-5129 |
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.
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.
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
We found this trial at
1
site
St. Louis, Missouri 63108
Principal Investigator: Peter Nagele, MD, MSc
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