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Esmolol for Treatment of Perioperative Tachycardia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01208402
Recruitment Status : Terminated (Baxter has terminated the study for inadequate enrollment rate accrual.)
First Posted : September 24, 2010
Results First Posted : November 19, 2014
Last Update Posted : December 12, 2014
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition High-risk, Non-cardiovascular Surgeries
Intervention Drug: Esmolol
Enrollment 76
Recruitment Details 76 subject signed consent. 58 subjects met all inclusion/exclusion criteria and were randomized into the study.
Pre-assignment Details  
Arm/Group Title Long-Acting Beta Blocker Esmolol
Hide Arm/Group Description Administer patient's routine oral long acting beta blocker on day of surgery (standard of care). 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.
Period Title: Overall Study
Started 31 28
Completed 30 28
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title Long-Acting Beta Blocker Esmolol Total
Hide Arm/Group Description Administer patient's routine oral long acting beta blocker on day of surgery (standard of care). 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 of all reporting groups
Overall Number of Baseline Participants 31 28 59
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
18 years and older Number Analyzed 31 participants 28 participants 59 participants
31 28 59
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 28 participants 59 participants
Female
9
  29.0%
7
  25.0%
16
  27.1%
Male
22
  71.0%
21
  75.0%
43
  72.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants 28 participants 59 participants
31 28 59
1.Primary Outcome
Title Percentage of Intraoperative Case Time With Heart Rate (HR) <60 or >80 Bpm
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Long-Acting Beta Blocker Esmolol
Hide Arm/Group Description:
Administer patient's routine oral long acting beta blocker on day of surgery (standard of care).
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 Number of Participants Analyzed 30 26
Median (Inter-Quartile Range)
Unit of Measure: percentage of case minutes
39.2
(13.6 to 83)
37.3
(14.4 to 64.6)
2.Primary Outcome
Title Percentage of Postoperative First Three Hours With Heart Rate (HR) <60 or >80 Bpm
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Long-Acting Beta Blocker Esmolol
Hide Arm/Group Description:
Administer patient's routine oral long acting beta blocker on day of surgery (standard of care).
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 Number of Participants Analyzed 23 23
Median (Inter-Quartile Range)
Unit of Measure: percentage of 3 hour interval
56.5
(8.0 to 93.8)
39.2
(8.3 to 79.6)
3.Primary Outcome
Title Percentage of Postoperative Hours 4 to 12 With Heart Rate (HR) <60 or >80 Bpm.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Long-Acting Beta Blocker Esmolol
Hide Arm/Group Description:
Administer patient's routine oral long acting beta blocker on day of surgery (standard of care).
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 Number of Participants Analyzed 18 16
Median (Inter-Quartile Range)
Unit of Measure: percentage of 8 hour interval
39.5
(14.2 to 69.8)
37
(8.2 to 56.9)
4.Secondary Outcome
Title Percentage of Intraoperative Case Time With Systolic Blood Pressure <95 mmHg
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Long-Acting Beta Blocker Esmolol
Hide Arm/Group Description:
Administer patient's routine oral long acting beta blocker on day of surgery (standard of care).
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 Number of Participants Analyzed 30 26
Median (Inter-Quartile Range)
Unit of Measure: percentage of surgery minutes
3.3
(0 to 9.1)
3.1
(0 to 9.0)
5.Secondary Outcome
Title Percentage of Postoperative First Three Hours With Systolic Blood Pressure <95 mmHg
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Long-Acting Beta Blocker Esmolol
Hide Arm/Group Description:
Administer patient's routine oral long acting beta blocker on day of surgery (standard of care).
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 Number of Participants Analyzed 23 23
Median (Inter-Quartile Range)
Unit of Measure: percentage of 3 hour interval
0
(0 to 1.4)
0
(0 to 6.4)
6.Secondary Outcome
Title Percentage of Postoperative Hours 4 to 12 With Systolic Blood Pressure <95 mmHg
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Long-Acting Beta Blocker Esmolol
Hide Arm/Group Description:
Administer patient's routine oral long acting beta blocker on day of surgery (standard of care).
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 Number of Participants Analyzed 18 16
Median (Inter-Quartile Range)
Unit of Measure: percentage of 8 hour interval
0
(0 to 12.2)
6.8
(0 to 15.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Long-Acting Beta Blocker Esmolol
Hide Arm/Group Description Administer patient's routine oral long acting beta blocker on day of surgery (standard of care). 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.
All-Cause Mortality
Long-Acting Beta Blocker Esmolol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Long-Acting Beta Blocker Esmolol
Affected / at Risk (%) Affected / at Risk (%)
Total   2/31 (6.45%)   2/28 (7.14%) 
Blood and lymphatic system disorders     
Hemorrhage [1]  0/31 (0.00%)  1/28 (3.57%) 
Cardiac disorders     
myocardial infarction  0/31 (0.00%)  1/28 (3.57%) 
Gastrointestinal disorders     
Intra-abdominal retroperitoneal abscess  1/31 (3.23%)  0/28 (0.00%) 
Psychiatric disorders     
Change in Mental Status  1/31 (3.23%)  0/28 (0.00%) 
[1]
Hemorrhage status post aortobifemoral bypass
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Long-Acting Beta Blocker Esmolol
Affected / at Risk (%) Affected / at Risk (%)
Total   16/31 (51.61%)   19/28 (67.86%) 
Blood and lymphatic system disorders     
HYPOMAGNESEAMIA  0/31 (0.00%)  1/28 (3.57%) 
HYPERNATREMIA  1/31 (3.23%)  0/28 (0.00%) 
HYPONATREMIA  1/31 (3.23%)  0/28 (0.00%) 
HYPOKALEMIA  1/31 (3.23%)  0/28 (0.00%) 
ANEMIA  0/31 (0.00%)  1/28 (3.57%) 
Cardiac disorders     
HYERTENSION  0/31 (0.00%)  1/28 (3.57%) 
DIAPHORESIS  0/31 (0.00%)  1/28 (3.57%) 
CHEST PAIN  1/31 (3.23%)  1/28 (3.57%) 
TACHYCARDIA  4/31 (12.90%)  4/28 (14.29%) 
ATRIAL FIBRILLATION  1/31 (3.23%)  0/28 (0.00%) 
HYPOTENSION  4/31 (12.90%)  4/28 (14.29%) 
None reversible ischemia in the inferior right heart  1/31 (3.23%)  0/28 (0.00%) 
BRADYCARDIA  0/31 (0.00%)  1/28 (3.57%) 
Elevated troponin  0/31 (0.00%)  3/28 (10.71%) 
Gastrointestinal disorders     
VOMITING  0/31 (0.00%)  1/28 (3.57%) 
CONSTIPATION  0/31 (0.00%)  1/28 (3.57%) 
HEARTBURN  0/31 (0.00%)  1/28 (3.57%) 
NAUSEA  2/31 (6.45%)  0/28 (0.00%) 
DIARRHIA  2/31 (6.45%)  0/28 (0.00%) 
ABDOMINAL PAIN  1/31 (3.23%)  0/28 (0.00%) 
ILEUS  0/31 (0.00%)  3/28 (10.71%) 
General disorders     
Fever  1/31 (3.23%)  0/28 (0.00%) 
Apresthesia  1/31 (3.23%)  0/28 (0.00%) 
Infections and infestations     
WOUND INFECTION  0/31 (0.00%)  1/28 (3.57%) 
Intra-abdominal retroperitoneal abscess  1/31 (3.23%)  0/28 (0.00%) 
Metabolism and nutrition disorders     
HYPERGLYCEMIA  1/31 (3.23%)  0/28 (0.00%) 
Musculoskeletal and connective tissue disorders     
Heavy feeling bilateral arm  1/31 (3.23%)  0/28 (0.00%) 
Clumsiness left arm  1/31 (3.23%)  0/28 (0.00%) 
Nervous system disorders     
CONFUSION  1/31 (3.23%)  0/28 (0.00%) 
CHANGED MENTAL STATUS  1/31 (3.23%)  0/28 (0.00%) 
DIFUSE BRAIN DISFUNCTION  1/31 (3.23%)  0/28 (0.00%) 
Agitation  1/31 (3.23%)  0/28 (0.00%) 
DELIRIUM TREMENS  0/31 (0.00%)  1/28 (3.57%) 
Renal and urinary disorders     
Low urine output  1/31 (3.23%)  0/28 (0.00%) 
Urinary tract infection  2/31 (6.45%)  0/28 (0.00%) 
Decrease urine output  1/31 (3.23%)  0/28 (0.00%) 
Mildly elevated serum creatinine  1/31 (3.23%)  0/28 (0.00%) 
Mild right hydronephrosis  0/31 (0.00%)  1/28 (3.57%) 
Respiratory, thoracic and mediastinal disorders     
DIFFICULTY OF BREATHING  0/31 (0.00%)  1/28 (3.57%) 
ATELECTASIS  0/31 (0.00%)  1/28 (3.57%) 
HYPOXIA  1/31 (3.23%)  1/28 (3.57%) 
Productive cough  0/31 (0.00%)  1/28 (3.57%) 
PULMONARY EDEMA  1/31 (3.23%)  0/28 (0.00%) 
PNEUMONIA  1/31 (3.23%)  0/28 (0.00%) 
Significant SQ air with SOB  1/31 (3.23%)  0/28 (0.00%) 
Surgical and medical procedures     
POST-SURGICAL BLEEDING  0/31 (0.00%)  1/28 (3.57%) 
POST-SURGICAL HEMATOMA  0/31 (0.00%)  1/28 (3.57%) 
INTRA-OPERATIVE BLEEDING  1/31 (3.23%)  0/28 (0.00%) 
POST DISCHAGE PAIN  1/31 (3.23%)  0/28 (0.00%) 
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: William White / Statistician
Organization: Duke University Medical Center - Department of Anesthesiology
Phone: 919-684-4081
EMail: white013@mc.duke.edu
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01208402    
Other Study ID Numbers: Pro00024224
First Submitted: September 10, 2010
First Posted: September 24, 2010
Results First Submitted: November 13, 2014
Results First Posted: November 19, 2014
Last Update Posted: December 12, 2014