A Phase 3 interventional study of Esmolol in High-risk, Non-cardiovascular Surgeries, sponsored by Duke University. Terminated at 3 sites in United States. Open to participants aged 41 Years and older. Per ClinicalTrials.gov, last updated 2014-12-12.
Sponsored by Duke University · Phase 3, Interventional, and Treatment
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.
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.
623 studies on the registry are indexed under Tachycardia; 81 are open to participants now.
This study's enrollment of 76 is above the median of 64 across 379 interventional studies indexed under Tachycardia.
Browse Tachycardia studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Revised Cardiac Risk Index 1(below) Cardiac Risk Index 1 or greater (below)
Exclusion Criteria:
oral administration of long acting beta blocker as standard of care on the day of surgery
Drug: Esmolol
given 30 minutes prior to induction up to 12 hours post-op
Drug: Esmolol
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
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.
Time frame: 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.
Time frame: 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.
Time frame: Postoperative hours 4-12
Percentage of Intraoperative Case Time With Systolic Blood Pressure <95 mmHg
Duration of intraoperative case time patient was not in the target window of SBP \> 95 mmHg, expressed as percent of total case minutes. SBP is measured from start of surgery to end of surgery at 5 minute intervals or less.
Time frame: 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
Duration of postoperative first three hours patient was not in the target window of SBP \> 95 mmHg, expressed as percent of the total 3 hours. SBP is measured from end of surgery to 3 hours postoperatively at 5 minute intervals for first hour and every 15 minutes thereafter.
Time frame: end of surgery to 3 hours
Percentage of Postoperative Hours 4 to 12 With Systolic Blood Pressure <95 mmHg
Duration of postoperative hours 4 to 12 patient was not in the target window of SBP \> 95 mmHg, expressed as percent of the total 9 hours. SBP was measured during hours four and five at 30 minute intervals and once every hour for the next 7 hours, through 12 hours postoperatively.
Time frame: Postoperative hours 4-12
76 subject signed consent. 58 subjects met all inclusion/exclusion criteria and were randomized into the study.
| Milestone | Long-Acting Beta Blocker | Esmolol |
|---|---|---|
| Started | 31 | 28 |
| Completed | 30 | 28 |
| Not completed | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
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.
| percentage of case minutes | Long-Acting Beta Blocker | Esmolol |
|---|---|---|
| Percentage of Intraoperative Case Time With Heart Rate (HR) <60 or >80 Bpm | 39.2 (13.6 to 83) | 37.3 (14.4 to 64.6) |
Duration of intraoperative case time patient was not in the target window of SBP \> 95 mmHg, expressed as percent of total case minutes. SBP is measured from start of surgery to end of surgery at 5 minute intervals or less.
| percentage of surgery minutes | Long-Acting Beta Blocker | Esmolol |
|---|---|---|
| Percentage of Intraoperative Case Time With Systolic Blood Pressure <95 mmHg | 3.3 (0 to 9.1) | 3.1 (0 to 9.0) |
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.
| percentage of 3 hour interval | Long-Acting Beta Blocker | Esmolol |
|---|---|---|
| Percentage of Postoperative First Three Hours With Heart Rate (HR) <60 or >80 Bpm | 56.5 (8.0 to 93.8) | 39.2 (8.3 to 79.6) |
Duration of postoperative first three hours patient was not in the target window of SBP \> 95 mmHg, expressed as percent of the total 3 hours. SBP is measured from end of surgery to 3 hours postoperatively at 5 minute intervals for first hour and every 15 minutes thereafter.
| percentage of 3 hour interval | Long-Acting Beta Blocker | Esmolol |
|---|---|---|
| Percentage of Postoperative First Three Hours With Systolic Blood Pressure <95 mmHg | 0 (0 to 1.4) | 0 (0 to 6.4) |
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.
| percentage of 8 hour interval | Long-Acting Beta Blocker | Esmolol |
|---|---|---|
| Percentage of Postoperative Hours 4 to 12 With Heart Rate (HR) <60 or >80 Bpm. | 39.5 (14.2 to 69.8) | 37 (8.2 to 56.9) |
Duration of postoperative hours 4 to 12 patient was not in the target window of SBP \> 95 mmHg, expressed as percent of the total 9 hours. SBP was measured during hours four and five at 30 minute intervals and once every hour for the next 7 hours, through 12 hours postoperatively.
| percentage of 8 hour interval | Long-Acting Beta Blocker | Esmolol |
|---|---|---|
| Percentage of Postoperative Hours 4 to 12 With Systolic Blood Pressure <95 mmHg | 0 (0 to 12.2) | 6.8 (0 to 15.2) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Long-Acting Beta Blocker | — | 2/31 (6.5%) | 16/31 (51.6%) |
| Esmolol | — | 2/28 (7.1%) | 19/28 (67.9%) |
| Event | Long-Acting Beta Blocker | Esmolol |
|---|---|---|
| HemorrhageBlood and lymphatic system disorders | 0/31 | 1/28 |
| myocardial infarctionCardiac disorders | 0/31 | 1/28 |
| Intra-abdominal retroperitoneal abscessGastrointestinal disorders | 1/31 | 0/28 |
| Change in Mental StatusPsychiatric disorders | 1/31 | 0/28 |
| Event | Long-Acting Beta Blocker | Esmolol |
|---|---|---|
| TACHYCARDIACardiac disorders | 4/31 | 4/28 |
| HYPOTENSIONCardiac disorders | 4/31 | 4/28 |
| ILEUSGastrointestinal disorders | 0/31 | 3/28 |
| Elevated troponinCardiac disorders | 0/31 | 3/28 |
| Urinary tract infectionRenal and urinary disorders | 2/31 | 0/28 |
| NAUSEAGastrointestinal disorders | 2/31 | 0/28 |
| DIARRHIAGastrointestinal disorders | 2/31 | 0/28 |
| HYERTENSIONCardiac disorders | 0/31 | 1/28 |
| VOMITINGGastrointestinal disorders | 0/31 | 1/28 |
| CONSTIPATIONGastrointestinal disorders | 0/31 | 1/28 |
| Age, Customized(participants) | Long-Acting Beta Blocker | Esmolol | Total |
|---|---|---|---|
| 18 years and older | 31 | 28 | 59 |
| Sex: Female, Male(Participants) | Long-Acting Beta Blocker | Esmolol | Total |
|---|---|---|---|
| Female | 9 | 7 | 16 |
| Male | 22 | 21 | 43 |
| Region of Enrollment(participants) | Long-Acting Beta Blocker | Esmolol | Total |
|---|---|---|---|
| United States | 31 | 28 | 59 |
This study is terminated, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Duke University