Hypothermia for Cardiac Arrest in Paediatrics

PHASE2CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

January 31, 2005

Primary Completion Date

September 30, 2009

Study Completion Date

September 30, 2010

Conditions
Cardiac Arrest
Interventions
OTHER

Normothermia

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.

OTHER

Hypothermia

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.

Trial Locations (4)

Unknown

The Hospital for Sick Children, Toronto

Sainte-Justine Hospital, Montreal

Starship Children's Hospital, Auckland

Great Ormond Street Hospital, London

All Listed Sponsors
lead

The Hospital for Sick Children

OTHER

NCT00754481 - Hypothermia for Cardiac Arrest in Paediatrics | Biotech Hunter | Biotech Hunter