Delayed Rewarming for Neuroprotection in Infants Following Cardiopulmonary Bypass Surgery

NCT ID: NCT03036072

Last Updated: 2020-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2019-05-31

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.

Conditions

Post-Op Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Strict Normothermia

Patients will be rewarmed to 36.5 degrees centigrade in the operating room and maintained here by conventional means in the PICU.

Group Type: ACTIVE_COMPARATOR

Strict normothermia

Intervention Type: OTHER

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.

Group Type: EXPERIMENTAL

Delayed Rewarming

Intervention Type: DEVICE

Use of the servo-controlled cooling blanket for delayed rewarming to target temperature.

Interventions

Strict normothermia

Intervention Type: OTHER

Delayed Rewarming

Use of the servo-controlled cooling blanket for delayed rewarming to target temperature.

Intervention Type: DEVICE

Eligibility 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

• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MaineHealth

OTHER

Sponsor Role: collaborator

Alexa Craig

OTHER

Sponsor Role: lead

Responsible Party

Alexa Craig

Assistant Professor of Pediatrics

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Alexa K Craig, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor of Pediatrics

Locations

Maine Medical Center

Portland, Maine, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

4KL2TR001063-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB 4489

Identifier Type: -

Identifier Source: org_study_id