Esmolol for Treatment of Perioperative Tachycardia

NCT01208402 | Terminated Phase 3 Results

• 1 other identifier: Pro00024224
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 3

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 rate before, during and immediately after surgery.

Conditions

High-risk, Non-cardiovascular Surgeries

Outcome Measures

Primary Outcomes (3)

• Percentage of Intraoperative Case Time With Heart Rate (HR) <60 or >80 Bpm

  Duration of intraoperative excursion (ie, time spent) outside Target HR range defined as 60 to 80 bpm during surgery, expressed as percent of case minutes. Vital signs are measured from start of surgery to end of surgery at 5 minute intervals or less.

  Start of surgery to end of surgery, an average duration of 245 minutes

• Percentage of Postoperative First Three Hours With Heart Rate (HR) <60 or >80 Bpm

  Duration of postoperative first three hours spent outside Target HR range defined as 60 to 80 bpm, expressed as percent of the total 3 hours. Vital signs are measured from end of surgery to 3 hours postoperatively at 5 minute intervals for the first hour and every 15 minutes thereafter.

  End of surgery to 3 hours

• Percentage of Postoperative Hours 4 to 12 With Heart Rate (HR) <60 or >80 Bpm.

  Duration of postoperative hours 4 to 12 spent outside Target HR range defined as 60 to 80 bpm, expressed as percent of the total 9 hours. Vital signs are measured during hours four and five at 30 minute intervals and once every hour for the next 7 hours, through 12 hours postoperatively.

  Postoperative hours 4-12

Secondary Outcomes (3)

• Percentage of Intraoperative Case Time With Systolic Blood Pressure <95 mmHg

  Start of surgery to end of surgery, an average duration of 245 minutes

• Percentage of Postoperative First Three Hours With Systolic Blood Pressure <95 mmHg

  end of surgery to 3 hours

• Percentage of Postoperative Hours 4 to 12 With Systolic Blood Pressure <95 mmHg

  Postoperative hours 4-12

Study Arms (2)

oral long acting beta blocker

ACTIVE COMPARATOR

oral administration of long acting beta blocker as standard of care on the day of surgery

Drug: Esmolol

Esmolol infusion

EXPERIMENTAL

given 30 minutes prior to induction up to 12 hours post-op

Drug: Esmolol

Interventions

Esmolol DRUG

Infusion will be started at 50 mcg/kg/min for 4 minutes and titrated in increments of 50 mcg/kg/min up to a maximum of 300mcg/kg/min (maintenance dose) to maintain a heart rate between 60 and 80 beats per minute (bpm) while maintaining a minimum systolic blood pressure (SBP) of 95 mmHg during the length of surgery and up to 12 hours post-operatively.

Also known as: Brevibloc

Esmolol infusion; oral long acting beta blocker

Eligibility Criteria

• Age: 41 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Duke University: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (3)

Durham VA Medical Center

Durham, North Carolina, 27705, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Interventions

esmolol

Results Point of Contact

• Title: William White / Statistician
• Organization: Duke University Medical Center - Department of Anesthesiology

white013@mc.duke.edu

919-684-4081

Study Officials

• Solomon Aronson, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2010
• First Posted: September 24, 2010
• Study Start: September 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: December 12, 2014
• Results First Posted: November 19, 2014

Record last verified: 2014-11

Locations

US (3)