Status:
TERMINATED
Esmolol for Treatment of Perioperative Tachycardia
Lead Sponsor:
Duke University
Collaborating Sponsors:
Baxter Healthcare Corporation
Conditions:
High-risk, Non-cardiovascular Surgeries
Eligibility:
All Genders
41+ years
Phase:
PHASE3
Brief 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 ra...
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 particula...
Eligibility Criteria
Inclusion
- Males or Females
- Age \> 40y/o
- Scheduled high risk (ASA II-IV) non-cardiac surgery with anticipated 12 hour post-operative ICU care
- Written informed consent
- Patients on a stable chronic oral beta-blocker therapy
- 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
- Active bleeding
- Untreated left main disease
- Active cardiac condition (eg unstable angina pectoris, acute exacerbation of CHF, serious arrhythmias, symptomatic valve disease)
- Preoperative positive troponin T
- Contraindication for esmolol use
- Previous allergy or intolerance to esmolol
- Cancer with an expected life expectancy \< 6 months
- Pregnancy or lactating or planning to become pregnant
- Failure to provide informed consent, unable to understand or follow instructions.
- History of drug allergy or idiosyncrasy to beta-adrenergic drugs
- Recent history (within 1 year) of drug or alcohol abuse
- Patients with a Pacemaker
- Abnormal liver function Child-Pugh - B
- Body Mass Index \> 45
- Reactive airway disease (defined as a history of hospitalization with status asthmaticus within the past one year)
- Surgery scheduled to begin after 2pm
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT01208402
Start Date
September 1 2010
End Date
July 1 2013
Last Update
December 12 2014
Active Locations (3)
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1
Durham VA Medical Center
Durham, North Carolina, United States, 27705
2
Duke University Medical Center
Durham, North Carolina, United States, 27710
3
Ohio State University
Columbus, Ohio, United States, 43210