Delayed Rewarming for Neuroprotection in Infants Following Cardiopulmonary Bypass Surgery

Post-Op Complication Clinical Trial

Official title:

Delayed Rewarming for Neuroprotection in Infants Following Cardiopulmonary Bypass Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03036072
• Other study ID #: IRB 4489
• Secondary ID: 4KL2TR001063-04
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: May 2019

Study information

• Verified date: April 2020
• Source: Maine Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 2019
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Post-Op Complication
• Postoperative Complications

Intervention

Other:
• Strict normothermia

Device:
• Delayed Rewarming
Use of the servo-controlled cooling blanket for delayed rewarming to target temperature.

Locations

Country	Name	City	State
United States	Maine Medical Center	Portland	Maine

Sponsors (2)

Lead Sponsor	Collaborator
Alexa Craig	Maine Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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?	4 days
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?	4 days