Clinical trial NCT00754481: Hypothermia for Cardiac Arrest in Paediatrics
Official title: Hypothermia for Cardiac Arrest in Paediatrics (HypCAP) - Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cardiac Arrest
Keywords: Paediatrics
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2008-09-18
Enrollment: 38
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesized that, following cardiac arrest in pediatric patients, hypothermia therapy will improve the proportion of patients with a good functional outcome compared to a normothermic control group.

Detailed description: Cardiac arrest is associated with a high morbidity and mortality in children and hypothermia therapy has the potential to be beneficial in children following cardiac arrest. We have a track record of both clinical and laboratory research of hypothermia therapy following cardiac arrest at the Hospital for Sick Children and have completed a 3-site randomized controlled pilot study of hypothermia therapy following cardiac arrest in children funded by The Hospital for Sick Children Research Institute and the Heart and Stroke Foundation of Ontario. This protocol was used to develop the protocol for the THAPCA trials (see 2 manuscripts published Moler et al NEJM 2015 and 2017 and multiple other manuscripts). Hypothermia therapy, compared to active maintenance of normothermia, had no beneficial effect on functional outcome or mortality in children with out-of-hospital or in-hospital cardiac arrest.

Eligibility criteria: Inclusion Criteria:

* Informed consent by parent or legal guardian
* Age ≥ 38 weeks gestation up to and including 17 years
* Patient admitted with a diagnosis of a cardiac arrest requiring compressions ≥3 minutes
* Remain comatose i.e. have Glasgow Coma Score less than or equal to 10 assessed at the tertiary level pediatric hospital at least 1 hour post- cardiac arrest
* Invasive mechanical ventilation

Exclusion Criteria:

* Cardiac arrest lasting ≥45 minutes, irregardless of commencement of ECMO
* Refractory hemorrhagic shock
* Dysrhythmia leading to cardiac arrest, where cooling would be part of standard therapy
* Suspected diagnosis of brain death as defined as fixed and dilated pupils, Glasgow Coma Score of 3 and no evidence of brain function on neurological examination
* Patients who have had a prolonged cardiac arrest at the scene of a trauma
* Decision to withhold (DNR) or withdraw life sustaining therapies
* Acute Birth asphyxia
* Terminal illness, not expected to survive 12 months
* Cardiac arrest caused by septic shock
* Severe neurodevelopmental disability or persistent vegetative state prior to cardiac arrest
* Near drowning in ice water and temperature \<32ºC on admission to study site
* It has been more than 6 hours following cardiac arrest (estimated by first responder)
* Previous enrolment in the HypCAP Pilot Study
* Pregnant
* Parent/Guardian refuse consent
* Responsible physician refuses to enrol patient

Primary outcomes:
measure: The percentage of children achieving a "good outcome", that is, a PCPC of 1-3 will be assessed using the Paediatric Cerebral Performance Category scores
timeFrame: Assessed at 12 months post cardiac arrest
Secondary outcomes:
measure: Cognitive and motor measures
timeFrame: Assessed at 12 months post-arrest
measure: Mortality
timeFrame: Assessed at 1, 3, 6, and 12 months post-arrest
measure: Cerebral edema
timeFrame: 12 months
measure: Adverse effects of hypothermia therapy
timeFrame: 12 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Montreal
country: Canada
facility: Sainte-Justine Hospital
state: Quebec
city: Auckland
country: New Zealand
facility: Starship Children's Hospital
city: London
country: United Kingdom
facility: Great Ormond Street Hospital
Study officials:
affiliation: The Hospital for Sick Children
name: Jamie Hutchison, MD
role: PRINCIPAL_INVESTIGATOR
References: