Status:
COMPLETED
Hypothermia for Cardiac Arrest in Paediatrics
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Cardiac Arrest
Eligibility:
All Genders
1-17 years
Phase:
PHASE2
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 normotherm...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00754481
Start Date
January 1 2005
End Date
September 1 2010
Last Update
July 14 2021
Active Locations (4)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada
2
Sainte-Justine Hospital
Montreal, Quebec, Canada
3
Starship Children's Hospital
Auckland, New Zealand
4
Great Ormond Street Hospital
London, United Kingdom