NCT00797680.
Trial name or title | Duration of Hypothermia for Neuroprotection After Paediatric Cardiac Arrest |
Methods | Randomized, open label, parallel assignment, safety and efficacy Phase II study |
Participants | 1 week ‐ 17 years Chest compressions by a healthcare worker In‐hospital and out‐of‐hospital arrest GCS ≤ 8 PICU physician decision to use therapeutic hypothermia Central venous or arterial catheter in situ |
Interventions | 1) Therapeutic hypothermia: 72 hours at 33 ± 1ºC 2) Therapeutic hypothermia: 24 hours at 33 ± 1ºC |
Outcomes | 1) Degree of brain injury as measured by serum and urine biomarkers and magnetic resonance spectroscopy at hospital discharge 2 ) Frequency of adverse events at 30 days |
Starting date | October 2008 |
Contact information | Dr Ericka Fink Children's Hospital of Pittsburgh, Pennsylvania, USA. finkel@ccm.upmc.edu |
Notes | Planned enrolment 40 Planned end date April 2014 |