Duration of Hypothermia for Neuroprotection After Pediatric Cardiac Arrest
Condition: Cardiac Arrest; Brain Injury
MeSH terms: Brain Injuries; Heart Arrest; Hypothermia
Study type: Interventional
Phase: Phase 2

Summary: 
      In this study, children who survive cardiac arrest will be evaluated whether 24 or 72 hours
      of whole body hypothermia (cooling) during recovery is better to help prevent brain injury
      and improve outcome. The investigators will also test the safety of cooling patients for 24
      and 72 hours. The investigators hypothesize that 72 hours of cooling will be more beneficial
      than 24 hours without compromising safety.
    

Detailed description: 
      Cooling has been shown to decrease the amount of brain injury that can occur after heart
      attacks in adults and in newborn babies with birth asphyxia (a lack of blood flow and oxygen
      to the fetus). It is unknown if cooling is effective in children after cardiac arrest.
      However, cooling is recommended by the American Heart Association as a "consideration" for
      use in children after cardiac arrest to prevent brain injury and has been used by doctors in
      our intensive care unit since 2002.

      Children will be randomly assigned to receive either 24 or 72 hours of cooling and compare
      the results of 1) blood-and urine derived markers of brain injury, and 2) brain magnetic
      resonance imaging and spectroscopy (MRI and MRS), which measures the anatomy and chemical
      patterns in the brain without using ionizing radiation, between the two groups of patients
      with 24 or 72 hours of cooling. We will also evaluate if cooling has any effect on patient
      outcome and quality of life at 6 months and one year using telephone or mail questionnaires.

      A child may take part in this research study if he or she had a cardiac arrest, received help
      with breathing and chest compressions to get a spontaneous heart rate by a health care
      worker, and remains unconscious in the intensive care unit (ICU). The attending physician in
      the ICU has already decided to cool your child to provide protection for his or her brain
      function.

      Children invited to participate in this study also are between 1 week and 17 years of age,
      have access tubes already in place in an artery or vein for blood draws, a urine catheter,
      are able to undergo MRI and MRS brain scans, and, if female, cannot be pregnant.

      Patients can not have had an acute brain injury from other causes (ex., meningitis, trauma),
      hemorrhage (excess bleeding from any site), congenital heart disease, do not resuscitate
      status, are undergoing a brain death examination, or have a known coagulation defect that
      makes them bleed more easily. The study will be performed on a total of 40 children strictly
      in this hospital.
    

Intervention name(s): 72 hours hypothermia; 24 hours hypothermia
Intervention type(s): Other; Other
Intervention description(s): 72 hours mild hypothermia (33 +/1 1 degree Celsius); 24 hours mild hypothermia (33 +/1 1 degree Celsius)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric cardiac arrest