Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-OH [Out of Hospital] Trial
Condition: Cardiac Arrest
MeSH terms: Heart Arrest; Hypothermia
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Therapeutic Hypothermia; Therapeutic Normothermia
Intervention type(s): Procedure; Other
Intervention description(s): Participants who are assigned to receive hypothermia will be cooled to a target temperature of 33º C plus or minus 1º C (32 to 34º C). This temperature will be maintained for 48 hours (2 days) and then participants will be warmed to a target temperature of 36.75º C plus or minus 0.75º C (36 to 37.5º C). This temperature will be maintained until 120 hours (5 days) after the cardiac arrest.; Participants who are assigned to receive therapeutic normothermia will have their temperature maintained at 36.75º C plus or minus 0.75º C (36° to 37.5º C) for 120 hours (5 days) after the cardiac arrest.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cardiac Arrest; Cardiopulmonary Arrest; Pediatric Cardiac Arrest; VABS; Vineland Adaptive Behavior Survey; POPC/PCPC; hypoxic-ichemic encephalopathy