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Hypothermia for Cardiac Arrest in Paediatrics

NCT00754481 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2021-07-14

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Jamie Hutchison, MD · The Hospital for Sick Children

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2009-09-30
Completion
2010-09-30

Countries

  • Canada
  • New Zealand
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00754481 on ClinicalTrials.gov