Cardiac Arrest Clinical Trial
Official title:
Therapeutic Hypothermia After Pediatric Cardiac Arrest (Out of Hospital)
Cardiac arrest is a sudden, unexpected loss of heart function. Therapeutic hypothermia, in which the body's temperature is lowered and maintained several degrees below normal for a period of time, has been used to successfully treat adults who have experienced cardiac arrest. This study will evaluate the efficacy of therapeutic hypothermia at increasing survival rates and reducing the risk of brain injury in infants and children who experience a cardiac arrest while out of the hospital.
Cardiac arrest occurs when the heart suddenly stops beating and blood flow to the body is
halted. It can occur while people are in the hospital because of a medical condition, or
while people are out of the hospital as a result of an accident or other causes. Cardiac
arrest is a serious event that is associated with high rates of death and long-term
disability. When a person experiences cardiac arrest, insufficient amount of blood flow and
oxygen can result in brain injury.
Therapeutic hypothermia is a therapy that involves a controlled lowering of the body
temperature and then maintenance of this lower temperature for a period of time. The
treatment may result in reduced brain injury. Therapeutic hypothermia has been successfully
used in adults who experience cardiac arrest to improve survival rates and health outcomes,
and it has also been studied in newborn infants who have suffered from perinatal asphyxia.
The purpose of this study is to evaluate the efficacy of therapeutic hypothermia at improving
survival rates and reducing brain injury in infants and children who experience cardiac
arrest while out of the hospital.
Study researchers will conduct this study in collaboration with the following two pediatric
clinical research networks: the Pediatric Emergency Care Applied Research Network (PECARN),
funded by the Emergency Medical Services for Children (EMSC) program, and the National
Institute of Child Health and Human Development (NICHD) Collaborative Pediatric Critical Care
Research Network (CPCCRN).
The study will enroll infants and children who have suffered a cardiac arrest while out of
the hospital. Randomization must occur within 6 hours of return of spontaneous circulation.
Participants will be randomly assigned to receive either therapeutic hypothermia or
therapeutic normothermia. Participants receiving therapeutic hypothermia will have their body
temperature reduced to between 32 to 34° Celsius (C) and will remain at this temperature for
2 days. Their body temperature will then be slowly increased to the normal temperature of 36
to 37.5° C, which will be maintained until 5 days after the cardiac arrest. Participants
receiving therapeutic normothermia will have their normal temperature maintained between 36
to 37.5° C for 5 days after the cardiac arrest. Special temperature control blankets will be
placed to maintain body temperature in the assigned range. After 5 days, each participant's
temperature will be managed by their medical care team.
While participants are in the hospital, they will undergo frequent blood and urine
collections, chest x-rays, and temperature measurements; parents of participants will
complete questionnaires. When participants are ready to leave the hospital, study researchers
will perform a physical and functional assessment. Twenty-eight days after the cardiac
arrest, researchers will contact parents of participants to gather information on the
participants' health and medical condition. At Months 3 and 12, a child development expert
will contact parents to gather medical information. At Month 12, participants will attend a
study visit for a neurologic examination and testing with a psychologist trained in
rehabilitation.
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