Trial Outcomes & Findings for Esmolol for Treatment of Perioperative Tachycardia (NCT NCT01208402)
NCT ID: NCT01208402
Last Updated: 2014-12-12
Results Overview
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.
TERMINATED
PHASE3
76 participants
Start of surgery to end of surgery, an average duration of 245 minutes
2014-12-12
Participant Flow
76 subject signed consent. 58 subjects met all inclusion/exclusion criteria and were randomized into the study.
Participant milestones
| Measure |
Long-Acting Beta Blocker
Administer patient's routine oral long acting beta blocker on day of surgery (standard of care).
|
Esmolol
Replace patient's routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
28
|
|
Overall Study
COMPLETED
|
30
|
28
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Long-Acting Beta Blocker
Administer patient's routine oral long acting beta blocker on day of surgery (standard of care).
|
Esmolol
Replace patient's routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Esmolol for Treatment of Perioperative Tachycardia
Baseline characteristics by cohort
| Measure |
Long-Acting Beta Blocker
n=31 Participants
Administer patient's routine oral long acting beta blocker on day of surgery (standard of care).
|
Esmolol
n=28 Participants
Replace patient's routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18 years and older
|
31 participants
n=5 Participants
|
28 participants
n=7 Participants
|
59 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
28 participants
n=7 Participants
|
59 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Start of surgery to end of surgery, an average duration of 245 minutesPopulation: Three enrolled cases (1 in the oral long acting beta blocker group and 2 in the Esmolol infusion group) were excluded from calculations a priori because they received diltiazem, a calcium channel blocker which lowers heart rate, before the operation.
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.
Outcome measures
| Measure |
Long-Acting Beta Blocker
n=30 Participants
Administer patient's routine oral long acting beta blocker on day of surgery (standard of care).
|
Esmolol
n=26 Participants
Replace patient's routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
|
|---|---|---|
|
Percentage of Intraoperative Case Time With Heart Rate (HR) <60 or >80 Bpm
|
39.2 percentage of case minutes
Interval 13.6 to 83.0
|
37.3 percentage of case minutes
Interval 14.4 to 64.6
|
PRIMARY outcome
Timeframe: End of surgery to 3 hoursPopulation: Ten cases (7 in the oral long acting beta blocker group and 3 in the Esmolol infusion group) were missing some of the postoperative vital sign measurements, resulting in gaps too long for valid calculation of the postoperative outcomes only.
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.
Outcome measures
| Measure |
Long-Acting Beta Blocker
n=23 Participants
Administer patient's routine oral long acting beta blocker on day of surgery (standard of care).
|
Esmolol
n=23 Participants
Replace patient's routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
|
|---|---|---|
|
Percentage of Postoperative First Three Hours With Heart Rate (HR) <60 or >80 Bpm
|
56.5 percentage of 3 hour interval
Interval 8.0 to 93.8
|
39.2 percentage of 3 hour interval
Interval 8.3 to 79.6
|
PRIMARY outcome
Timeframe: Postoperative hours 4-12Population: Specific vital sign measurements were available for calculation of outcomes during the final 9 hours postoperatively in 18 cases in the Long-Acting beta blocker group and in 16 cases in the Esmolol group.
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.
Outcome measures
| Measure |
Long-Acting Beta Blocker
n=18 Participants
Administer patient's routine oral long acting beta blocker on day of surgery (standard of care).
|
Esmolol
n=16 Participants
Replace patient's routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
|
|---|---|---|
|
Percentage of Postoperative Hours 4 to 12 With Heart Rate (HR) <60 or >80 Bpm.
|
39.5 percentage of 8 hour interval
Interval 14.2 to 69.8
|
37 percentage of 8 hour interval
Interval 8.2 to 56.9
|
SECONDARY outcome
Timeframe: Start of surgery to end of surgery, an average duration of 245 minutesPopulation: Three enrolled cases (1 in the oral long acting beta blocker group and 2 in the Esmolol infusion group) were excluded from calculations a priori because they received diltiazem, a calcium channel blocker which lowers heart rate, before the operation.
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.
Outcome measures
| Measure |
Long-Acting Beta Blocker
n=30 Participants
Administer patient's routine oral long acting beta blocker on day of surgery (standard of care).
|
Esmolol
n=26 Participants
Replace patient's routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
|
|---|---|---|
|
Percentage of Intraoperative Case Time With Systolic Blood Pressure <95 mmHg
|
3.3 percentage of surgery minutes
Interval 0.0 to 9.1
|
3.1 percentage of surgery minutes
Interval 0.0 to 9.0
|
SECONDARY outcome
Timeframe: end of surgery to 3 hoursPopulation: Ten cases (7 in the oral long acting beta blocker group and 3 in the Esmolol infusion group) were missing some of the postoperative vital sign measurements, resulting in gaps too long for valid calculation of the postoperative outcomes only.
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.
Outcome measures
| Measure |
Long-Acting Beta Blocker
n=23 Participants
Administer patient's routine oral long acting beta blocker on day of surgery (standard of care).
|
Esmolol
n=23 Participants
Replace patient's routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
|
|---|---|---|
|
Percentage of Postoperative First Three Hours With Systolic Blood Pressure <95 mmHg
|
0 percentage of 3 hour interval
Interval 0.0 to 1.4
|
0 percentage of 3 hour interval
Interval 0.0 to 6.4
|
SECONDARY outcome
Timeframe: Postoperative hours 4-12Population: Specific vital sign measurements were available for calculation of outcomes during the final 9 hours postoperatively in 18 cases in the Long-Acting BB group and in 16 cases in the Esmolol group.
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.
Outcome measures
| Measure |
Long-Acting Beta Blocker
n=18 Participants
Administer patient's routine oral long acting beta blocker on day of surgery (standard of care).
|
Esmolol
n=16 Participants
Replace patient's routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
|
|---|---|---|
|
Percentage of Postoperative Hours 4 to 12 With Systolic Blood Pressure <95 mmHg
|
0 percentage of 8 hour interval
Interval 0.0 to 12.2
|
6.8 percentage of 8 hour interval
Interval 0.0 to 15.2
|
Adverse Events
Long-Acting Beta Blocker
Esmolol
Serious adverse events
| Measure |
Long-Acting Beta Blocker
n=31 participants at risk
Administer patient's routine oral long acting beta blocker on day of surgery (standard of care).
|
Esmolol
n=28 participants at risk
Replace patient's routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
|
|---|---|---|
|
Gastrointestinal disorders
Intra-abdominal retroperitoneal abscess
|
3.2%
1/31
|
0.00%
0/28
|
|
Psychiatric disorders
Change in Mental Status
|
3.2%
1/31
|
0.00%
0/28
|
|
Blood and lymphatic system disorders
Hemorrhage
|
0.00%
0/31
|
3.6%
1/28
|
|
Cardiac disorders
myocardial infarction
|
0.00%
0/31
|
3.6%
1/28
|
Other adverse events
| Measure |
Long-Acting Beta Blocker
n=31 participants at risk
Administer patient's routine oral long acting beta blocker on day of surgery (standard of care).
|
Esmolol
n=28 participants at risk
Replace patient's routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
|
|---|---|---|
|
Cardiac disorders
HYERTENSION
|
0.00%
0/31
|
3.6%
1/28
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/31
|
3.6%
1/28
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/31
|
3.6%
1/28
|
|
Gastrointestinal disorders
HEARTBURN
|
0.00%
0/31
|
3.6%
1/28
|
|
Blood and lymphatic system disorders
HYPOMAGNESEAMIA
|
0.00%
0/31
|
3.6%
1/28
|
|
Renal and urinary disorders
Low urine output
|
3.2%
1/31
|
0.00%
0/28
|
|
Renal and urinary disorders
Urinary tract infection
|
6.5%
2/31
|
0.00%
0/28
|
|
Gastrointestinal disorders
NAUSEA
|
6.5%
2/31
|
0.00%
0/28
|
|
Gastrointestinal disorders
DIARRHIA
|
6.5%
2/31
|
0.00%
0/28
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
3.2%
1/31
|
0.00%
0/28
|
|
Nervous system disorders
CONFUSION
|
3.2%
1/31
|
0.00%
0/28
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
3.2%
1/31
|
0.00%
0/28
|
|
Respiratory, thoracic and mediastinal disorders
DIFFICULTY OF BREATHING
|
0.00%
0/31
|
3.6%
1/28
|
|
Respiratory, thoracic and mediastinal disorders
ATELECTASIS
|
0.00%
0/31
|
3.6%
1/28
|
|
Cardiac disorders
DIAPHORESIS
|
0.00%
0/31
|
3.6%
1/28
|
|
Gastrointestinal disorders
ILEUS
|
0.00%
0/31
|
10.7%
3/28
|
|
Infections and infestations
WOUND INFECTION
|
0.00%
0/31
|
3.6%
1/28
|
|
Cardiac disorders
CHEST PAIN
|
3.2%
1/31
|
3.6%
1/28
|
|
Cardiac disorders
TACHYCARDIA
|
12.9%
4/31
|
14.3%
4/28
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
3.2%
1/31
|
3.6%
1/28
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/31
|
3.6%
1/28
|
|
Renal and urinary disorders
Decrease urine output
|
3.2%
1/31
|
0.00%
0/28
|
|
Infections and infestations
Intra-abdominal retroperitoneal abscess
|
3.2%
1/31
|
0.00%
0/28
|
|
Renal and urinary disorders
Mildly elevated serum creatinine
|
3.2%
1/31
|
0.00%
0/28
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
3.2%
1/31
|
0.00%
0/28
|
|
General disorders
Fever
|
3.2%
1/31
|
0.00%
0/28
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EDEMA
|
3.2%
1/31
|
0.00%
0/28
|
|
Blood and lymphatic system disorders
HYPERNATREMIA
|
3.2%
1/31
|
0.00%
0/28
|
|
Nervous system disorders
CHANGED MENTAL STATUS
|
3.2%
1/31
|
0.00%
0/28
|
|
Cardiac disorders
HYPOTENSION
|
12.9%
4/31
|
14.3%
4/28
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA
|
3.2%
1/31
|
0.00%
0/28
|
|
Blood and lymphatic system disorders
HYPONATREMIA
|
3.2%
1/31
|
0.00%
0/28
|
|
Blood and lymphatic system disorders
HYPOKALEMIA
|
3.2%
1/31
|
0.00%
0/28
|
|
Nervous system disorders
DIFUSE BRAIN DISFUNCTION
|
3.2%
1/31
|
0.00%
0/28
|
|
Surgical and medical procedures
POST-SURGICAL BLEEDING
|
0.00%
0/31
|
3.6%
1/28
|
|
Surgical and medical procedures
POST-SURGICAL HEMATOMA
|
0.00%
0/31
|
3.6%
1/28
|
|
Blood and lymphatic system disorders
ANEMIA
|
0.00%
0/31
|
3.6%
1/28
|
|
Cardiac disorders
None reversible ischemia in the inferior right heart
|
3.2%
1/31
|
0.00%
0/28
|
|
Nervous system disorders
Agitation
|
3.2%
1/31
|
0.00%
0/28
|
|
Nervous system disorders
DELIRIUM TREMENS
|
0.00%
0/31
|
3.6%
1/28
|
|
Renal and urinary disorders
Mild right hydronephrosis
|
0.00%
0/31
|
3.6%
1/28
|
|
Surgical and medical procedures
INTRA-OPERATIVE BLEEDING
|
3.2%
1/31
|
0.00%
0/28
|
|
Cardiac disorders
BRADYCARDIA
|
0.00%
0/31
|
3.6%
1/28
|
|
Cardiac disorders
Elevated troponin
|
0.00%
0/31
|
10.7%
3/28
|
|
Musculoskeletal and connective tissue disorders
Heavy feeling bilateral arm
|
3.2%
1/31
|
0.00%
0/28
|
|
Musculoskeletal and connective tissue disorders
Clumsiness left arm
|
3.2%
1/31
|
0.00%
0/28
|
|
General disorders
Apresthesia
|
3.2%
1/31
|
0.00%
0/28
|
|
Respiratory, thoracic and mediastinal disorders
Significant SQ air with SOB
|
3.2%
1/31
|
0.00%
0/28
|
|
Surgical and medical procedures
POST DISCHAGE PAIN
|
3.2%
1/31
|
0.00%
0/28
|
Additional Information
William White / Statistician
Duke University Medical Center - Department of Anesthesiology
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place