Trial Outcomes & Findings for Delayed Rewarming for Neuroprotection in Infants Following Cardiopulmonary Bypass Surgery (NCT NCT03036072)
NCT ID: NCT03036072
Last Updated: 2020-07-13
Results Overview
In a population of infants with congenital heart disease undergoing cardiopulmonary bypass surgery, does delayed rewarming administered during the 12 hours after surgery, compared to standard care, decrease brain injury as measured by levels of serum biomarkers of brain injury, s100b and neuron specific enolase during the four days after surgery?
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
4 days
Results posted on
2020-07-13
Participant Flow
Participant milestones
| Measure |
Strict Normothermia
Patients will be rewarmed to 36.5 degrees centigrade in the operating room and maintained here by conventional means in the PICU.
Strict normothermia
|
Delayed Rewarming
Patient will be rewarmed to 35.0 degrees centigrade in the operating room, then slowly rewarmed to normal physiologic temperature (36.5) over 12 hours by using a servo-controlled cooling blanket. Normothermia will be maintained by the cooling blanket for an additional 12 hours.
Delayed Rewarming: Use of the servo-controlled cooling blanket for delayed rewarming to target temperature.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
13
|
|
Overall Study
COMPLETED
|
12
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Strict Normothermia
Patients will be rewarmed to 36.5 degrees centigrade in the operating room and maintained here by conventional means in the PICU.
Strict normothermia
|
Delayed Rewarming
Patient will be rewarmed to 35.0 degrees centigrade in the operating room, then slowly rewarmed to normal physiologic temperature (36.5) over 12 hours by using a servo-controlled cooling blanket. Normothermia will be maintained by the cooling blanket for an additional 12 hours.
Delayed Rewarming: Use of the servo-controlled cooling blanket for delayed rewarming to target temperature.
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Delayed Rewarming for Neuroprotection in Infants Following Cardiopulmonary Bypass Surgery
Baseline characteristics by cohort
| Measure |
Strict Normothermia
n=12 Participants
Patients will be rewarmed to 36.5 degrees centigrade in the operating room and maintained here by conventional means in the PICU.
Strict normothermia
|
Delayed Rewarming
n=10 Participants
Patient will be rewarmed to 35.0 degrees centigrade in the operating room, then slowly rewarmed to normal physiologic temperature (36.5) over 12 hours by using a servo-controlled cooling blanket. Normothermia will be maintained by the cooling blanket for an additional 12 hours.
Delayed Rewarming: Use of the servo-controlled cooling blanket for delayed rewarming to target temperature.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Less than 2 weeks at surgery
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Customized
More than 2 weeks at surgery
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
10 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Trisomy 21
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 daysPopulation: Laboratory storage and transportation issues resulted in less than expected number of viable specimens that could be analyzed at all 5 time points.
In a population of infants with congenital heart disease undergoing cardiopulmonary bypass surgery, does delayed rewarming administered during the 12 hours after surgery, compared to standard care, decrease brain injury as measured by levels of serum biomarkers of brain injury, s100b and neuron specific enolase during the four days after surgery?
Outcome measures
| Measure |
Strict Normothermia
n=12 Participants
Patients will be rewarmed to 36.5 degrees centigrade in the operating room and maintained here by conventional means in the PICU.
Strict normothermia
|
Delayed Rewarming
n=10 Participants
Patient will be rewarmed to 35.0 degrees centigrade in the operating room, then slowly rewarmed to normal physiologic temperature (36.5) over 12 hours by using a servo-controlled cooling blanket. Normothermia will be maintained by the cooling blanket for an additional 12 hours.
Delayed Rewarming: Use of the servo-controlled cooling blanket for delayed rewarming to target temperature.
|
|---|---|---|
|
Infants With Elevated s100b and NSE
|
11 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 4 daysIn a population of infants with congenital heart disease undergoing cardiopulmonary bypass surgery, is there evidence for increased frequency of severe, moderate or other adverse events in the delayed rewarming group compared to the standard of care group?
Outcome measures
| Measure |
Strict Normothermia
n=12 Participants
Patients will be rewarmed to 36.5 degrees centigrade in the operating room and maintained here by conventional means in the PICU.
Strict normothermia
|
Delayed Rewarming
n=10 Participants
Patient will be rewarmed to 35.0 degrees centigrade in the operating room, then slowly rewarmed to normal physiologic temperature (36.5) over 12 hours by using a servo-controlled cooling blanket. Normothermia will be maintained by the cooling blanket for an additional 12 hours.
Delayed Rewarming: Use of the servo-controlled cooling blanket for delayed rewarming to target temperature.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
3 Participants
|
3 Participants
|
Adverse Events
Strict Normothermia
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Delayed Rewarming
Serious events: 2 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Strict Normothermia
n=12 participants at risk
Patients will be rewarmed to 36.5 degrees centigrade in the operating room and maintained here by conventional means in the PICU.
Strict normothermia
|
Delayed Rewarming
n=10 participants at risk
Patient will be rewarmed to 35.0 degrees centigrade in the operating room, then slowly rewarmed to normal physiologic temperature (36.5) over 12 hours by using a servo-controlled cooling blanket. Normothermia will be maintained by the cooling blanket for an additional 12 hours.
Delayed Rewarming: Use of the servo-controlled cooling blanket for delayed rewarming to target temperature.
|
|---|---|---|
|
Cardiac disorders
ECMO after surgery
|
8.3%
1/12 • Number of events 1 • Until 48 hours post surgery.
|
10.0%
1/10 • Number of events 1 • Until 48 hours post surgery.
|
|
Cardiac disorders
CPR after surgery
|
8.3%
1/12 • Number of events 1 • Until 48 hours post surgery.
|
0.00%
0/10 • Until 48 hours post surgery.
|
|
Cardiac disorders
Return to Operating Room
|
25.0%
3/12 • Number of events 3 • Until 48 hours post surgery.
|
10.0%
1/10 • Number of events 1 • Until 48 hours post surgery.
|
|
Nervous system disorders
Stroke or Seizure
|
0.00%
0/12 • Until 48 hours post surgery.
|
0.00%
0/10 • Until 48 hours post surgery.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place