Post-Op Complication
Conditions
Keywords
Therapeutic Hypothermia
Brief summary
This is an unblinded, single center, randomized study of infants with congenital heart disease undergoing cardiopulmonary bypass surgery, randomized to either the delayed rewarming intervention or to the standard of care (strict normothermia).
Detailed description
Control Group: The congenital heart surgery will be performed according to usual practice with the degree of intra-operative hypothermia determined by the cardiothoracic surgeon based on the anticipated complexity of the case. Following completion of the surgical procedure, the infant will be rapidly rewarmed on CPB at a rate of 0.2 to 0.3°C per minute to a normothermic temperature of 36.5°C. Infants in this group will be given a single weight-based 15 mg/kg dose of intravenous Tylenol in the operating room (OR) by the anesthesiologist as the chest is being closed. The infant will be transported to the Pediatric Intensive Care Unit (PICU) for routine post-operative monitoring. If the infant develops a fever, ice packs will be applied to the axilla and groin per usual routine and removed once the fever has abated. Experimental group: Partial rewarming will occur on CPB to 35°C. During the last hour of surgery, the infant's temperature will be maintained at 35°C while the chest is closed by using a BairHugger and lowering the room temperature. Transfusions of packed red blood cells, fresh frozen plasma and cryoprecipitate will not be automatically warmed. Infants will be given a single 15 mg/kg dose of IV Tylenol in the OR. The infant will be transported to the PICU at 35°C and placed on the temperature-regulating blanket. The infant will be incrementally rewarmed with increases in temperature of 0.3°C every 2 hours for 6 hours, then 0.2°C every 2 hours for 6 hours to the goal temperature of 36.5°C. Once the infant is stable, EEG will be performed for 48 hours to screen for seizures. The PI will interpret the EEG every 6-8 hours. The infant will remain on the blanket at 36.5°C for another 12 hours. The blanket and esophageal temperature probe will then be removed a total of 24 hours after surgery was completed.
Interventions
OTHERStrict normothermia
DEVICEDelayed Rewarming
Use of the servo-controlled cooling blanket for delayed rewarming to target temperature.
Sponsors
MaineHealth
Alexa Craig
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of congenital heart disease requiring congenital heart surgery on bypass 2. Age less than 6 months at the time of surgery 3. Intra-operative hypothermia less than or equal to 35°C
Exclusion criteria
1. Concern for underlying coagulation disorder such as hemophilia 2. Death in the operating room 3. Inability to wean of cardiopulmonary bypass at conclusion of surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infants With Elevated s100b and NSE | 4 days | 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? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 4 days | In 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? |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 12 |
| 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. | 10 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Strict Normothermia | Delayed Rewarming | Total |
|---|---|---|---|
| Age, Customized Less than 2 weeks at surgery | 4 Participants | 3 Participants | 7 Participants |
| Age, Customized More than 2 weeks at surgery | 8 Participants | 7 Participants | 15 Participants |
| Race/Ethnicity, Customized Unknown | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized White | 10 Participants | 8 Participants | 18 Participants |
| Region of Enrollment United States | 12 participants | 10 participants | 22 participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Male | 8 Participants | 6 Participants | 14 Participants |
| Trisomy 21 | 4 Participants | 2 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 1 / 10 |
| other Total, other adverse events | 0 / 12 | 0 / 10 |
| serious Total, serious adverse events | 3 / 12 | 2 / 10 |
Outcome results
Primary
Infants With Elevated s100b and NSE
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?
Time frame: 4 days
Population: Laboratory storage and transportation issues resulted in less than expected number of viable specimens that could be analyzed at all 5 time points.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Strict Normothermia | Infants With Elevated s100b and NSE | 11 Participants |
| Delayed Rewarming | Infants With Elevated s100b and NSE | 9 Participants |
Secondary
Number of Participants With Adverse Events
In 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?
Time frame: 4 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Strict Normothermia | Number of Participants With Adverse Events | 3 Participants |
| Delayed Rewarming | Number of Participants With Adverse Events | 3 Participants |