Cooling Therapy for Pediatric Cardiac Arrest
(ICECAP Trial)
Recruiting in Palo Alto (17 mi)
+52 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Michigan
Must not be taking: Epinephrine, Norepinephrine, Chemotherapy, others
Disqualifiers: Severe neurodevelopmental deficits, Terminal illness, Trauma, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?This trial is testing if cooling the body can help protect the brains of children who are in a coma after a heart attack. The researchers believe that keeping the body cool might help more children recover well or improve the recovery of those already doing well.
Do I need to stop my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What data supports the effectiveness of the treatment Therapeutic Hypothermia for pediatric cardiac arrest?
Therapeutic hypothermia has been shown to improve neurological outcomes in adults after cardiac arrest and in newborns with oxygen deprivation at birth. It is being studied for its potential benefits in children after cardiac arrest, although the best methods and patient selection are still being researched.
12345Is cooling therapy safe for children after cardiac arrest?
Research on cooling therapy (also known as therapeutic hypothermia) for children after cardiac arrest has looked at its feasibility and side effects. While the studies focus on its use in emergencies, they do mention monitoring for adverse events, suggesting that safety is a key consideration in its application.
12456How is the treatment Therapeutic Hypothermia unique for pediatric cardiac arrest?
Therapeutic Hypothermia is unique because it involves cooling the body to a target temperature of 32-34 degrees Celsius (about 90-93 degrees Fahrenheit) using cooling blankets and intravenous iced saline, aiming to protect the brain after cardiac arrest. This approach is different from other treatments as it focuses on reducing brain injury by lowering body temperature for 24-72 hours, which is not a standard practice for this condition.
13456Eligibility Criteria
The P-ICECAP trial is for children aged 2 days to under 18 years who have survived a cardiac arrest but are in a coma. They must be on mechanical ventilation, have been resuscitated within the past 6 hours, and their legal guardians must agree to life support for at least 120 hours. Children with severe heart instability, certain pre-existing conditions, or those who do not speak English or Spanish are excluded.Inclusion Criteria
Definitive temperature control device initiated
I need a machine to help me breathe through a tube.
I am under 18 years old, born at or after 38 weeks of pregnancy.
+4 more
Exclusion Criteria
I have been diagnosed with cryoglobulinemia before.
I am currently experiencing severe, uncontrollable bleeding.
Prisoner
+16 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo induced hypothermia at varying durations for neuroprotection
5 days
In-hospital monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 months
Regular assessments
Participant Groups
This study tests how effective cooling the body (therapeutic hypothermia) is for protecting the brain after cardiac arrest in kids. It looks at whether cooling longer improves recovery. Kids will be randomly assigned different cooling durations to find out which works best.
10Treatment groups
Experimental Treatment
Group I: Cooling 96 hoursExperimental Treatment1 Intervention
The participant will be cooled to 33°C for 96 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
Group II: Cooling 84 hoursExperimental Treatment1 Intervention
The participant will be cooled to 33°C for 84 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
Group III: Cooling 72 hoursExperimental Treatment1 Intervention
The participant will be cooled to 33°C for 72 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
Group IV: Cooling 60 hoursExperimental Treatment1 Intervention
The participant will be cooled to 33°C for 60 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
Group V: Cooling 48 hoursExperimental Treatment1 Intervention
The participant will be cooled to 33°C for 48 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
Group VI: Cooling 36 hoursExperimental Treatment1 Intervention
The participant will be cooled to 33°C for 36 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
Group VII: Cooling 24 hoursExperimental Treatment1 Intervention
The participant will be cooled to 33°C for 24 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
Group VIII: Cooling 18 hoursExperimental Treatment1 Intervention
The participant will be cooled to 33°C for 18 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
Group IX: Cooling 12 hoursExperimental Treatment1 Intervention
The participant will be cooled to 33°Celsius (C) for 12 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
Group X: Cooling 0 hoursExperimental Treatment1 Intervention
Participants will be kept at a normal temperature for the whole 5 days.
Therapeutic Hypothermia is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Therapeutic Hypothermia for:
- Cardiac arrest in adults and children
- Birth asphyxia in newborns
🇪🇺 Approved in European Union as Therapeutic Hypothermia for:
- Cardiac arrest in adults and children
- Birth asphyxia in newborns
🇨🇦 Approved in Canada as Therapeutic Hypothermia for:
- Cardiac arrest in adults and children
- Birth asphyxia in newborns
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Children's Hospital of Los AngelesLos Angeles, CA
Children's Hospital of Pittsburgh (UPMC)Pittsburgh, PA
Dayton Children's HospitalDayton, OH
Loma Linda University Children's HospitalLoma Linda, CA
More Trial Locations
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Who Is Running the Clinical Trial?
University of MichiganLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
Kennedy Krieger Institute, Baltimore, MDCollaborator
References
A tertiary care center's experience with therapeutic hypothermia after pediatric cardiac arrest. [2021]To describe the use and feasibility of therapeutic hypothermia after pediatric cardiac arrest.
Rationale, timeline, study design, and protocol overview of the therapeutic hypothermia after pediatric cardiac arrest trials. [2022]To describe the rationale, timeline, study design, and protocol overview of the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials.
How I cool children in neurocritical care. [2021]Brain injury is the leading cause of death in our pediatric ICU [Au et al. Crit Care Med 36:A128, 2008]. Clinical care for brain injury remains largely supportive. Therapeutic hypothermia has been shown to be effective in improving neurological outcome after adult ventricular-arrhythmia-induced cardiac arrest and neonatal asphyxia, and is under investigation as a neuroprotectant after cardiac arrest and traumatic brain injury in children in our ICU and other centers. To induce hypothermia in children comatose after cardiac arrest we target 32-34 degrees C using cooling blankets and intravenous iced saline as primary methods for induction, for 24-72 h duration with vigilant re-warming. The objective of this article is to share our hypothermia protocol for cooling children with acute brain injury.
Can a Cold (4°C) IV Fluid Bolus to Induce Therapeutic Hypothermia Really Deliver 4°C to Children? [2016]Induced therapeutic hypothermia after pediatric cardiac arrest is under investigation. Animal and adult data suggest that rapid achievement of temperatures (T)
Hypothermia and pediatric cardiac arrest. [2021]The survival outcome following pediatric cardiac arrest still remains poor. Survival to hospital discharge ranges anywhere from 0 to 38% when considering both out-of-hospital and in-hospital arrests, with up to 50% of the survivors having neurologic injury. The use of mild induced hypothermia has not been definitively proven to improve outcomes following pediatric cardiac arrest. This may be due to the lack of consensus regarding target temperature, best method of cooling, optimal duration of cooling and identifying the patient population who will receive the greatest benefit. We review the current applications of induced hypothermia in pediatric patients following cardiac arrest after searching the current literature through Pubmed and Ovid journal databases. We put forth compiled recommendations/guidelines for initiating hypothermia therapy, its maintenance, associated monitoring and suggested adjunctive therapies to produce favorable neurologic and survival outcomes.
Induction and maintenance of therapeutic hypothermia after pediatric cardiac arrest: efficacy of a surface cooling protocol. [2021]To assess the feasibility, effectiveness, side effects, and adverse events associated with a standardized surface cooling protocol. Induced therapeutic hypothermia after pediatric cardiac arrest is an important intervention.