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
Intervention: Therapeutic Hypothermia; Therapeutic Normothermia
Intervention description: 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.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 295.0
Sex: All
Minimum age: 48 Hours
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Cardiac Arrest; Cardiopulmonary Arrest; Pediatric Cardiac Arrest; VABS; Vineland Adaptive Behavior Survey; POPC/PCPC; hypoxic-ichemic encephalopathy

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient suffered cardiac arrest requiring chest compressions for at least 2 minutes
             (120 seconds) with ROSC/ROC; AND

          -  Age greater than 48 hours (with a corrected gestational age of at least 38 weeks) and
             less than 18 years; AND

          -  Patient requires continuous mechanical ventilation; AND

          -  The cardiac arrest was unplanned (i.e., not part of cardiac surgical procedure)

        Exclusion Criteria:

          -  The parent or legal guardian does not speak English or Spanish (the only two languages
             in which VABS II is standardized)

          -  Randomization is impossible within six hours of ROSC; OR

          -  Patient is on extracorporeal membrane oxygenation (ECMO) when arrest occurs; OR

          -  Continuous infusion of epinephrine or norepinephrine at very high doses (≥2
             ug/kg/minute) received immediately prior to randomization; OR Glasgow Coma Scale motor
             response of five (localizing pain or for infants less than two years, withdraws to
             touch) or six (obeys commands, or for infants, normal spontaneous movement) prior to
             randomization; OR

          -  History of a prior cardiac arrest with chest compressions for at least two minutes
             during the current hospitalization but outside the 6 hour window for randomization; OR

          -  Pre-existing terminal illness with life expectancy < 12 months; OR

          -  Lack of commitment to aggressive intensive care therapies including do not resuscitate
             orders and other limitations to care; OR

          -  Cardiac arrest was associated with severe brain, thoracic, or abdominal trauma; OR

          -  Active and refractory severe bleeding prior to randomization; OR

          -  Near drowning in ice water with patient core temperature ≤32 °C on presentation; OR

          -  Patient is pregnant; OR

          -  Patient participation in a concurrent interventional trial whose protocol, in the
             judgment of the THAPCA investigators, prevents effective application of one or both
             THAPCA therapeutic treatment arms, or otherwise significantly interferes with carrying
             out the THAPCA protocol; OR

          -  Patient is newborn with acute birth asphyxia; OR

             _ Patient cared for in a neonatal intensive care unit (NICU) after arrest (ie, would
             not be admitted to PICU); OR

          -  Patient has sickle cell anemia; OR

          -  Patient known to have pre-existing cryoglobulinemia; OR

          -  Central nervous system tumor with ongoing chemotherapy or radiation therapy; OR

          -  Chronic hypothermia secondary to hypovolemic, pituitary, or related condition for
             which body temperature is consistently below 37 °C ; OR progressive degenerative
             encephalopathy; OR

          -  Any condition in which direct skin surface cooling would be contraindicated, such as
             large burns, decubitus ulcers, cellulitis, or other conditions with disrupted skin
             integrity (NOTE: patients with open chest CPR should be included but placement of
             cooling mattresses will be modified as needed); OR

          -  Previous enrollment in the THAPCA Trials.