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Tests treatment safety and results for Cardiac Arrest, Out-Of-Hospital
Official title Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)
ClinicalTrials.gov ID: NCT05376267
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 17
You may be able to join if
- 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
You likely can't join if
- 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...
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Long Beach, California, United States
- Los Angeles, California, United States
- Oakland, California, United States
- Orange, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- Santa Clara, California, United States
- Gainesville, Florida, United States
- Miami, Florida, United States
- St. Petersburg, Florida, United States
- Chicago, Illinois, United States
- Peoria, Illinois, United States
- Indianapolis, Indiana, United States
- Iowa City, Iowa, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
+ 38 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 days to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Long Beach, California, United States; Los Angeles, California, United States; Oakland, California, United States and 52 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.