Language: BG BG
← Back to results
Recruiting Not applicable NCT05376267

Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)

No applicable phase (e.g. observational)
Conditions: Cardiac Arrest, Out-Of-Hospital Hypothermia, Induced Hypoxia-Ischemia, Brain

Sponsor: University of Michigan

trial.available_in: БГ
Overview
This is a multicenter trial to establish the efficacy of cooling and the optimal duration of induced hypothermia for neuroprotection in pediatric comatose survivors of cardiac arrest. The study team hypothesizes that longer durations of cooling may improve either the proportion of children that attain a good neurobehavioral recovery or may result in better recovery among the proportion already categorized as having a good outcome.
Who can participate
Inclusion criteria: * Age 2 days to \< 18 years with corrected gestational age of at least 38 weeks * Chest compressions for at least 2 minutes * Coma or encephalopathy after resuscitation from Out-of-Hospital Cardiac Arrest (OHCA) * Requires continuous mechanical ventilation through endotracheal tube or tracheostomy * Definitive temperature control device initiated * Randomization within 6 hours of Return of Spontaneous Circulation (ROSC) * Informed consent from Legally Authorized Representative (LAR) including intent to maintain life support for 120 hours Exclusion criteria: * Glasgow Coma Motor Score (GCMS) = 6 * LAR does not speak English or Spanish * Duration of Cardiopulmonary Resuscitation (CPR) \> 60 minutes * Severe hemodynamic instability with continuous infusion of epinephrine or norepinephrine of 2 micrograms per kilogram per minute (μg/kg/minute) or initiation of Extracorporeal membrane oxygenation (ECMO) * Pre-existing severe neurodevelopmental deficits with Pediatric Cerebral Performance Category (PCPC) =5 or progressive degenerative encephalopathy * Pre-existing terminal illness, unlikely to survive to one year * Cardiac arrest associated with brain, thoracic, or abdominal trauma * Active and refractory severe bleeding prior to randomization * Extensive burns or skin lesions incompatible with surface cooling * Planned early withdrawal of life support before 120 hours * Sickle cell anemia * Pre-existing cryoglobulinemia * Non-fatal drowning in ice covered water * Central nervous system tumor with ongoing chemotherapy * Previous enrollment in P-ICECAP trial * Prisoner * Chronic hypothermia * New post-cardiac arrest diabetes insipidus * Pregnancy
Locations 5
Australia (1)
Queensland Children's Hospital
Brisbane , Queensland
Canada (1)
The Hospital for Sick Children
Toronto , Ontario
New Zealand (1)
Starship Children's Hospital
Grafton , Auckland
John S Beca, FRACP, FCICM
United Kingdom (1)
Birmingham Children's Hospital, United Kingdom
Birmingham
Hari Krishnan, MD
United States (1)
University of Alabama at Birmingham / Children's of Alabama
Birmingham , Alabama
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
2 Days
Maximum age
17 Years
Healthy volunteers
No
Start date
05.08.2022
Completion date
31.03.2028
Registry ID
NCT05376267
Source
anzctr
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.