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Delayed Rewarming for Neuroprotection in Infants Following Cardiopulmonary Bypass Surgery

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ClinicalTrials.gov Identifier: NCT03036072
Recruitment Status : Completed
First Posted : January 30, 2017
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
Alexa Craig, Maine Medical Center

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).

Condition or disease Intervention/treatment Phase
Post-Op Complication Other: Strict normothermia Device: Delayed Rewarming Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Delayed Rewarming for Neuroprotection in Infants Following Cardiopulmonary Bypass Surgery
Actual Study Start Date : May 2016
Actual Primary Completion Date : April 2018
Actual Study Completion Date : May 2019

Arm Intervention/treatment
Active Comparator: Strict Normothermia
Patients will be rewarmed to 36.5 degrees centigrade in the operating room and maintained here by conventional means in the PICU.
Other: Strict normothermia
Experimental: Delayed Rewarming
Patient will be rewarmed to 35.0 degrees centigrade in the operating room, then slowly rewarmed to normal physiologic temperature over 12 hours by using a servo-controlled cooling blanket. Normothermia will be maintained by the cooling blanket for an additional 12 hours.
Device: Delayed Rewarming
Use of the servo-controlled cooling blanket for delayed rewarming to target temperature.




Primary Outcome Measures :
  1. Serum biomarkers for brain injury [ Time Frame: 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 Outcome Measures :
  1. Developmental Outcomes [ Time Frame: 12 months ]
    i. In a population of infants with congenital heart disease undergoing cardiopulmonary bypass surgery, is the delayed rewarming intervention compared to standard of care, associated with improved performance on the Bayley Scales of Infant Development performed at age 12 months?

  2. Adverse events [ Time Frame: 4 days ]
    ii. 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?



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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036072


Locations
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United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
Sponsors and Collaborators
Maine Medical Center
Investigators
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Principal Investigator: Alexa K Craig, MD, MSc Assistant Professor of Pediatrics

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Responsible Party: Alexa Craig, Assistant Professor of Pediatrics, Maine Medical Center
ClinicalTrials.gov Identifier: NCT03036072     History of Changes
Other Study ID Numbers: IRB 4489
4KL2TR001063-04 ( U.S. NIH Grant/Contract )
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Alexa Craig, Maine Medical Center:
Therapeutic Hypothermia

Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes