Delayed Rewarming for Neuroprotection in Infants Following Cardiopulmonary Bypass Surgery
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/17/2018 |
| Start Date: | May 2016 |
| End Date: | April 2018 |
| Contact: | Alexa K Craig, MD, MSc |
| Email: | craiga@mmc.org |
| Phone: | 207-396-6920 |
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).
disease undergoing cardiopulmonary bypass surgery, randomized to either the delayed rewarming
intervention or to the standard of care (strict normothermia).
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.
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.
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
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