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Hypothermia for Cardiac Arrest in Paediatrics - NCT00754481-Toronto - 000(Clinical Trial 242325)



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City:  Toronto
Country:  
Canada
Conditions: Cardiac Arrest
Purpose: The investigators hypothesize 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.
Study summary: 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 begun 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. We are currently expanding the study to an 11 site pilot study with bridge funding from the American Heart Association. Recently two trials were published in the New England Journal of Medicine demonstrating the efficacy of 12 hours and 24 hours of hypothermia therapy following ventricular arrhythmia-induced cardiac arrest in adults. The results of these important studies suggest that hypothermia therapy will be beneficial in children following cardiac arrest. There are however important differences in the etiology, pathophysiology, neuropathology, therapy and outcome of cardiac arrest in children compared to adults. We need to conduct a pilot study of hypothermia therapy following cardiac arrest at 11 Children's Hospitals to test the feasibility of recruitment and to test the appropriateness of our inclusion/exclusion criteria prior to proceeding to a large multi-centre trial. We chose 11 large children's hospitals with large cardiac arrest populations with a track record of resuscitation research to improve the feasibility of patient recruitment into this pilot study. The pilot data will be used to do a sample size calculation for the larger randomized controlled study. It will also be important to demonstrate enrolment in an important sub-group of patients, those being placed on ECMO post-arrest. Patients randomized to cooling on ECMO will have rapid core cooling via the extracorporeal circuit and this rapid cooling may lead to a more pronounced therapeutic effect.
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
Study is available at: The Hospital for Sick Children
Toronto
Canada

Primary Contact:
Jamie Hutchison, MD
Email: jamie.hutchison@sickkids.ca
Phone: (416)813-7654
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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