Cardiac Arrest and Hypothermia Therapy (THAPCA)

Protocol Description

The purpose of this multi-center research study is to determine whether body cooling improves survival and brain functioning in children after cardiac arrest. During cardiac arrest, decreased blood flow to the brain can result in death or damage to the brain. Previous research with animals, adults and newborns has shown that in some situations body cooling can improve survival and brain functioning. Researchers hope to determine whether this applies to children as well.

Eligibility Criteria

This study is enrolling children between the ages of 48 hours and 18 years who are in the pediatric/cardiac intensive care unit (PICU/CICU) of Children’s Hospital of Pittsburgh of UPMC because they experienced cardiac arrest, a condition in which the heart temporarily stopped beating.
Females: Ages 2 days to 18 years
Males: Ages 2 days to 18 years

Requirements

Patients will be randomly assigned to receive body cooling or be kept at normal body temperature for a period of 48 hours. Body temperature will be controlled in both groups by a temperature-control blanket placed under and over the body. In the body-cooling group, body temperature will be kept between 89-93ºF for 48 hours, followed by a 16-hour warming period to normal body temperature. For either group, 5 days after cardiac arrest temperature will be managed according to the routine practice in the PICU/CICU.
Visits: Occurs while patient is in the PICU/CICU
Duration: 12 months for follow-up

Status: Open for Enrollment

Source(s) of Support

National Heart Blood and Lung Institute

Additional Information

Study Description at National Institutes of Health

Primary Investigator

Frank W. Moler, MD, MS (University of Michigan)

Children’s Hospital of Pittsburgh of UPMC investigators:

• Joseph A. Carcillo, MD
• Ericka L. Fink, MD

Contact Information

For information, please contact:
Joseph A. Carcillo, MD
412-692-6737