Trial Outcomes & Findings for Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery (NCT NCT02004613)
NCT ID: NCT02004613
Last Updated: 2021-04-06
Results Overview
The occurrence of postoperative atrial arrhythmias
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
798 participants
Primary outcome timeframe
From the end of surgery to postoperative day 5
Results posted on
2021-04-06
Participant Flow
Participant milestones
| Measure |
Dexmedetomidine
Dexmedetomidine infusion, without a bolus dose, (or a comparable volume of placebo) will be initiated before the surgical incision at a rate of 0.1 mcg/kg/hr at the end of bypass, the dose will be increased to 0.2 mcg/kg/hr. Postoperatively patients will continue to receive the study medication at a rate of 0.4mcg/kg/hr. The study medication infusion will be continued for a total of 24 hours from the initial administration time intra-operatively.
Dexmedetomidine: Dexmedetomidine
|
Placebo
normal saline administration matching dexmedetomidine rate of infusion.
Placebo: Normal saline administration matching dexmedetomidine rate of infusion
|
|---|---|---|
|
Overall Study
STARTED
|
400
|
398
|
|
Overall Study
COMPLETED
|
398
|
396
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Only reported the mean and standard deviation for each group. Age is not available for 4 patients.
Baseline characteristics by cohort
| Measure |
Dexmedetomidine
n=398 Participants
Dexmedetomidine infusion, without a bolus dose, (or a comparable volume of placebo) will be initiated before the surgical incision at a rate of 0.1 mcg/kg/hr at the end of bypass, the dose will be increased to 0.2 mcg/kg/hr. Postoperatively patients will continue to receive the study medication at a rate of 0.4mcg/kg/hr. The study medication infusion will be continued for a total of 24 hours from the initial administration time intra-operatively.
Dexmedetomidine: Dexmedetomidine
|
Placebo
n=396 Participants
normal saline administration matching dexmedetomidine rate of infusion.
Placebo: Normal saline administration matching dexmedetomidine rate of infusion
|
Total
n=794 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 11 • n=396 Participants • Only reported the mean and standard deviation for each group. Age is not available for 4 patients.
|
62 years
STANDARD_DEVIATION 12 • n=394 Participants • Only reported the mean and standard deviation for each group. Age is not available for 4 patients.
|
63 years
STANDARD_DEVIATION 12 • n=790 Participants • Only reported the mean and standard deviation for each group. Age is not available for 4 patients.
|
|
Sex: Female, Male
Female
|
132 Participants
n=396 Participants • 4 patients sex data were not availiable.
|
111 Participants
n=394 Participants • 4 patients sex data were not availiable.
|
243 Participants
n=790 Participants • 4 patients sex data were not availiable.
|
|
Sex: Female, Male
Male
|
264 Participants
n=396 Participants • 4 patients sex data were not availiable.
|
283 Participants
n=394 Participants • 4 patients sex data were not availiable.
|
547 Participants
n=790 Participants • 4 patients sex data were not availiable.
|
|
Race/Ethnicity, Customized
Race · white
|
365 Participants
n=395 Participants • 5 patients didn't had availiable race data.
|
363 Participants
n=394 Participants • 5 patients didn't had availiable race data.
|
728 Participants
n=789 Participants • 5 patients didn't had availiable race data.
|
|
Race/Ethnicity, Customized
Race · not white
|
30 Participants
n=395 Participants • 5 patients didn't had availiable race data.
|
31 Participants
n=394 Participants • 5 patients didn't had availiable race data.
|
61 Participants
n=789 Participants • 5 patients didn't had availiable race data.
|
|
Region of Enrollment
United States
|
398 participants
n=398 Participants
|
396 participants
n=396 Participants
|
794 participants
n=794 Participants
|
|
Modified Brief Pain Inventory
Overall Severity (any)
|
95 Participants
n=374 Participants • 44 patients' baseline MBPI information was not available. Any overall severity means any pain in the last 24 hours. Any pain inference means any pain that interfering with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life in the last 24 hours.
|
89 Participants
n=376 Participants • 44 patients' baseline MBPI information was not available. Any overall severity means any pain in the last 24 hours. Any pain inference means any pain that interfering with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life in the last 24 hours.
|
184 Participants
n=750 Participants • 44 patients' baseline MBPI information was not available. Any overall severity means any pain in the last 24 hours. Any pain inference means any pain that interfering with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life in the last 24 hours.
|
|
Modified Brief Pain Inventory
Pain interference (any)
|
85 Participants
n=398 Participants • 44 patients' baseline MBPI information was not available. Any overall severity means any pain in the last 24 hours. Any pain inference means any pain that interfering with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life in the last 24 hours.
|
83 Participants
n=396 Participants • 44 patients' baseline MBPI information was not available. Any overall severity means any pain in the last 24 hours. Any pain inference means any pain that interfering with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life in the last 24 hours.
|
168 Participants
n=794 Participants • 44 patients' baseline MBPI information was not available. Any overall severity means any pain in the last 24 hours. Any pain inference means any pain that interfering with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life in the last 24 hours.
|
PRIMARY outcome
Timeframe: From the end of surgery to postoperative day 5Population: 2 patients had no Atrial Arrhythmia data.
The occurrence of postoperative atrial arrhythmias
Outcome measures
| Measure |
Dexmedetomidine
n=397 Participants
Dexmedetomidine infusion, without a bolus dose, (or a comparable volume of placebo) will be initiated before the surgical incision at a rate of 0.1 mcg/kg/hr at the end of bypass, the dose will be increased to 0.2 mcg/kg/hr. Postoperatively patients will continue to receive the study medication at a rate of 0.4mcg/kg/hr. The study medication infusion will be continued for a total of 24 hours from the initial administration time intra-operatively.
Dexmedetomidine: Dexmedetomidine
|
Placebo
n=395 Participants
normal saline administration matching dexmedetomidine rate of infusion.
Placebo: Normal saline administration matching dexmedetomidine rate of infusion
|
|---|---|---|
|
Number of Patients With Atrial Arrhythmia
|
121 Participants
|
134 Participants
|
PRIMARY outcome
Timeframe: From the end of surgery to postoperative day 5Population: Delirium data is not available in 18 patients.
The occurrence of postoperative delirium
Outcome measures
| Measure |
Dexmedetomidine
n=389 Participants
Dexmedetomidine infusion, without a bolus dose, (or a comparable volume of placebo) will be initiated before the surgical incision at a rate of 0.1 mcg/kg/hr at the end of bypass, the dose will be increased to 0.2 mcg/kg/hr. Postoperatively patients will continue to receive the study medication at a rate of 0.4mcg/kg/hr. The study medication infusion will be continued for a total of 24 hours from the initial administration time intra-operatively.
Dexmedetomidine: Dexmedetomidine
|
Placebo
n=387 Participants
normal saline administration matching dexmedetomidine rate of infusion.
Placebo: Normal saline administration matching dexmedetomidine rate of infusion
|
|---|---|---|
|
Number of Patients With Delirium
|
67 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: From the end of surgery to postoperative day 5Population: Acute kidney injury data is not available in 16 patients.
Acute kidney injury is defined according to Acute Kidney Injury Network (AKIN) classifications. No risk means no risk of acute kidney injury, while a higher stage means worse kidney function.
Outcome measures
| Measure |
Dexmedetomidine
n=389 Participants
Dexmedetomidine infusion, without a bolus dose, (or a comparable volume of placebo) will be initiated before the surgical incision at a rate of 0.1 mcg/kg/hr at the end of bypass, the dose will be increased to 0.2 mcg/kg/hr. Postoperatively patients will continue to receive the study medication at a rate of 0.4mcg/kg/hr. The study medication infusion will be continued for a total of 24 hours from the initial administration time intra-operatively.
Dexmedetomidine: Dexmedetomidine
|
Placebo
n=389 Participants
normal saline administration matching dexmedetomidine rate of infusion.
Placebo: Normal saline administration matching dexmedetomidine rate of infusion
|
|---|---|---|
|
Number of Patients With Acute Kidney Injury
No risk
|
348 Participants
|
359 Participants
|
|
Number of Patients With Acute Kidney Injury
stage1
|
33 Participants
|
29 Participants
|
|
Number of Patients With Acute Kidney Injury
Stage2
|
4 Participants
|
0 Participants
|
|
Number of Patients With Acute Kidney Injury
Stage3
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 90 days after surgeryPopulation: Incisional pain at 90 days is not available in 205 patients.
Patients were evaluated at 90 days by modified Brief Pain Inventory.
Outcome measures
| Measure |
Dexmedetomidine
n=289 Participants
Dexmedetomidine infusion, without a bolus dose, (or a comparable volume of placebo) will be initiated before the surgical incision at a rate of 0.1 mcg/kg/hr at the end of bypass, the dose will be increased to 0.2 mcg/kg/hr. Postoperatively patients will continue to receive the study medication at a rate of 0.4mcg/kg/hr. The study medication infusion will be continued for a total of 24 hours from the initial administration time intra-operatively.
Dexmedetomidine: Dexmedetomidine
|
Placebo
n=300 Participants
normal saline administration matching dexmedetomidine rate of infusion.
Placebo: Normal saline administration matching dexmedetomidine rate of infusion
|
|---|---|---|
|
Number of Patients With Incisional Pain
|
79 Participants
|
93 Participants
|
Adverse Events
Dexmedetomidine
Serious events: 21 serious events
Other events: 234 other events
Deaths: 1 deaths
Placebo
Serious events: 8 serious events
Other events: 154 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Dexmedetomidine
n=394 participants at risk
Dexmedetomidine infusion, without a bolus dose, (or a comparable volume of placebo) will be initiated before the surgical incision at a rate of 0.1 mcg/kg/hr at the end of bypass, the dose will be increased to 0.2 mcg/kg/hr. Postoperatively patients will continue to receive the study medication at a rate of 0.4mcg/kg/hr. The study medication infusion will be continued for a total of 24 hours from the initial administration time intra-operatively.
Dexmedetomidine: Dexmedetomidine
|
Placebo
n=390 participants at risk
normal saline administration matching dexmedetomidine rate of infusion.
Placebo: Normal saline administration matching dexmedetomidine rate of infusion
|
|---|---|---|
|
Blood and lymphatic system disorders
Hemorrhage
|
1.0%
4/394 • 5 days
|
0.77%
3/390 • 5 days
|
|
Cardiac disorders
asystol
|
0.25%
1/394 • 5 days
|
0.26%
1/390 • 5 days
|
|
Cardiac disorders
heart failure
|
0.25%
1/394 • 5 days
|
0.00%
0/390 • 5 days
|
|
Cardiac disorders
re-intervention
|
0.00%
0/394 • 5 days
|
0.26%
1/390 • 5 days
|
|
Infections and infestations
infection
|
0.51%
2/394 • 5 days
|
0.00%
0/390 • 5 days
|
|
Nervous system disorders
seizure
|
0.00%
0/394 • 5 days
|
0.26%
1/390 • 5 days
|
|
Nervous system disorders
stroke
|
0.76%
3/394 • 5 days
|
0.26%
1/390 • 5 days
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.51%
2/394 • 5 days
|
0.00%
0/390 • 5 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxemia
|
0.25%
1/394 • 5 days
|
0.00%
0/390 • 5 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.25%
1/394 • 5 days
|
0.26%
1/390 • 5 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.25%
1/394 • 5 days
|
0.00%
0/390 • 5 days
|
|
Vascular disorders
hypotension
|
0.25%
1/394 • 5 days
|
0.00%
0/390 • 5 days
|
|
Cardiac disorders
Cardiogenic shock
|
0.25%
1/394 • 5 days
|
0.00%
0/390 • 5 days
|
|
Cardiac disorders
Myocardial infarction
|
0.25%
1/394 • 5 days
|
0.00%
0/390 • 5 days
|
|
Cardiac disorders
Pericardial effusion
|
0.25%
1/394 • 5 days
|
0.00%
0/390 • 5 days
|
|
Nervous system disorders
Transient Ischemic attack
|
0.25%
1/394 • 5 days
|
0.00%
0/390 • 5 days
|
Other adverse events
| Measure |
Dexmedetomidine
n=394 participants at risk
Dexmedetomidine infusion, without a bolus dose, (or a comparable volume of placebo) will be initiated before the surgical incision at a rate of 0.1 mcg/kg/hr at the end of bypass, the dose will be increased to 0.2 mcg/kg/hr. Postoperatively patients will continue to receive the study medication at a rate of 0.4mcg/kg/hr. The study medication infusion will be continued for a total of 24 hours from the initial administration time intra-operatively.
Dexmedetomidine: Dexmedetomidine
|
Placebo
n=390 participants at risk
normal saline administration matching dexmedetomidine rate of infusion.
Placebo: Normal saline administration matching dexmedetomidine rate of infusion
|
|---|---|---|
|
Cardiac disorders
Clinically important bradycardia
|
9.1%
36/394 • 5 days
|
11.5%
45/390 • 5 days
|
|
Blood and lymphatic system disorders
Clinically important hypotension
|
56.9%
224/394 • 5 days
|
35.9%
140/390 • 5 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place