Esmolol for Treatment of Perioperative Tachycardia
Information source: Duke University
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: High-risk, Non-cardiovascular Surgeries
Intervention: Esmolol (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Duke University Official(s) and/or principal investigator(s):
Solomon Aronson, MD, Principal Investigator, Affiliation: Duke University
Overall contact:
Naraida G. Balajonda, MD, MHSc, Phone: 919-681-4377, Email: narai.balajonda@duke.edu
Summary
The purpose of this study is to find out if Esmolol is a safe and effective alternative
treatment compared to standard treatment using a long acting beta blocker drug, in
controlling abnormal heart rate before, during and immediately after surgery.
Clinical Details
Official title: Safety and Efficacy of Esmolol for the Treatment of Peri-operative Tachycardia in Patients at Risk for Post Operative Adverse Ischemic Outcomes
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: Efficacy of continuous perioperative infusion of esmolol
Secondary outcome: Safety of continuous perioperative infusion of esmolol
Detailed description:
The benefit versus risk of perioperative beta blockade therapy for adverse ischemic event
risk reduction in high risk patients undergoing non-cardiac surgery has been recently
challenged. In particular the PeriOperative Ischemia Study Evaluation (POISE trial) showed a
cardio-protective effect only at the expense of a higher incidence of stroke and all-cause
mortality . In that study death and stroke were significantly associated with an increase in
hypotension and bradycardia. Long acting agents - aggressively administered to achieve heart rate (HR) control - appear to be associated with significant adverse outcomes (death,
stroke) despite myocardial ischemia and infarction reduction.
It is estimated that 20 percent of high risk patients come to surgery with chronic beta
blocker oral therapy. The American Heart Association recommends continuation of beta
blockers in this situation as beta-blocker withdrawal is associated with increased rate of
perioperative myocardial infarction . Protocols optimizing the perioperative administration
of beta-blockers in high-risk patients are therefore needed.
Esmolol is a cardioselective beta-blocker with a short elimination half-life (t1/2 = 9. 2
min) and no intrinsic sympathomimetic activity. Evidence has revealed that Esmolol, with
its unique short half life can be quickly titrated to both achieve a target hemodynamic
effect as well as reduce (or loose) its effect quickly in unstable situations thereby
mitigates undesired hypotension and / or bradycardia.
This study proposes to assess the Safety and Efficacy of dosing to target endpoints with
Esmolol - an ultra short acting beta blocker - the day of surgery compared to standard long
acting oral Metoprolol the day of surgery.
Eligibility
Minimum age: 41 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Males or Females
2. Age > 40y/o
3. Scheduled high risk (ASA II-IV) non-cardiac surgery with anticipated 12 hour
post-operative ICU care
4. Written informed consent
5. Patients on a stable chronic oral beta-blocker therapy
6. Revised Cardiac Risk Index 1(below) Cardiac Risk Index 1 or greater (below)
- a history of coronary disease
- a history of congestive heart failure
- a history of treated diabetes
- a history of cerebrovascular disease
- a history of chronic renal failure
Exclusion Criteria:
1. Active bleeding
2. Untreated left main disease
3. Active cardiac condition (eg unstable angina pectoris, acute exacerbation of CHF,
serious arrhythmias, symptomatic valve disease)
4. Preoperative positive troponin T
5. Contraindication for esmolol use
6. Previous allergy or intolerance to esmolol
7. Cancer with an expected life expectancy < 6 months
8. Pregnancy or lactating or planning to become pregnant
9. Failure to provide informed consent, unable to understand or follow instructions.
10. History of drug allergy or idiosyncrasy to beta-adrenergic drugs
11. Recent history (within 1 year) of drug or alcohol abuse
12. Patients with a Pacemaker
13. Abnormal liver function Child-Pugh - B
14. Body Mass Index > 45
15. Reactive airway disease (defined as a history of hospitalization with status
asthmaticus within the past one year)
16. Surgery scheduled to begin after 2pm
Locations and Contacts
Naraida G. Balajonda, MD, MHSc, Phone: 919-681-4377, Email: narai.balajonda@duke.edu
Duke University Medical Center, Durham, North Carolina 27710, United States; Recruiting
Mike Elgasim, Phone: 919-681-2217, Email: elgas001@mc.duke.edu
Naraida Balajonda, MD MHSc, Phone: 919-681-4377, Email: narai.balajonda@duke.edu
Christopher Young, MD, Sub-Investigator
Durham VA Medical Center, Durham, North Carolina 27705, United States; Active, not recruiting
Ohio State University, Columbus, Ohio 43210, United States; Recruiting
Nicolas Kong, MD, Phone: 614-366-1945, Email: nicolas.kong@osumc.edu
Demicha Rankin, MD, Principal Investigator
Additional Information
Starting date: September 2010
Last updated: June 5, 2012
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