A Phase 2 interventional study of Normothermia and Hypothermia in Cardiac Arrest, sponsored by The Hospital for Sick Children. Completed at 4 sites in 3 countries. Open to participants aged 1 Day to 17 Years. Per ClinicalTrials.gov, last updated 2021-07-14.
Sponsored by The Hospital for Sick Children · Phase 2, Interventional, and Treatment
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.
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.
966 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.
This study's enrollment of 38 is below the median of 100 across 557 interventional studies indexed under Heart Arrest.
Browse Heart Arrest studies →The Hospital for Sick Children is the lead sponsor of 568 studies on the registry; 81 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Other: Normothermia
Other: Hypothermia
Patients randomized to the Normothermia arm (esophageal temp 36.5-37.5 ºC) were maintained at an esophageal temperature of 36.5-37.5ºC for 48 hours. Patients who were hypothermic (temperature \< 35 ºC) when randomized to the normothermia group were rewarmed slowly using the servo-controlled mattress. Patients who were hyperthermic following randomization to the normothermia group were actively cooled to normothermia using the servo-controlled mattress. Neuromuscular blockers were administered as needed intravenously in both groups of patients to prevent shivering.
Patients randomized to the Hypothermia arm (esophageal temp 33º to 34 °C) were cooled rapidly using the cooling protocol developed for the Hypothermia Paediatric Head Injury Trial. A temperature probe was placed in the esophagus and its position confirmed using a chest radiograph. Patients were placed on a servo-controlled cooling blanket and covered in crushed ice (in sealed plastic bags covered by pillow cases) and a second cooling blanket. Once the esophageal temperature reached 34.0ºC, the ice and second cooling blanket was removed and esophageal temperature was maintained at 33º to 34 °C for 48 hours using the servo-controlled cooling mattress. Patients treated with ECMO were cooled using the extracorporeal circuit cooling-device. Rewarming was done at a rate of 0.5 ºC every 2 hours until an esophageal temperature of 36.5 ºC was reached. Thereafter temperature was recorded but not controlled by surface cooling.
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
Time frame: Assessed at 12 months post cardiac arrest
Cognitive and motor measures
Time frame: Assessed at 12 months post-arrest
Mortality
Time frame: Assessed at 1, 3, 6, and 12 months post-arrest
Cerebral edema
Time frame: 12 months
Adverse effects of hypothermia therapy
Time frame: 12 months
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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