Hypothermia for Cardiac Arrest in Paediatrics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00754481
Recruitment Status : Completed
First Posted : September 18, 2008
Last Update Posted : July 31, 2015
Information provided by (Responsible Party):
Jamie Hutchison, The Hospital for Sick Children

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cardiac Arrest Other: Normothermia Other: Hypothermia Phase 2

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 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hypothermia for Cardiac Arrest in Paediatrics (HypCAP) - Pilot Study
Study Start Date : January 2005
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1 Other: Normothermia
Patients randomized to the Normothermia arm (esophageal temp 36.5-37.5 ºC) will be maintained at an esophageal temperature of 36.5-37.5ºC for 48 hours. Patients who are hypothermic (temperature < 35 ºC) when randomized to the normothermia group will be rewarmed slowly using the servo-controlled mattress. Patients who are hyperthermic following randomization to the normothermia group will be actively cooled to normothermia using the servo-controlled mattress. Neuromuscular blockers will be administered as needed intravenously in both groups of patients to prevent shivering.
Experimental: 2 Other: Hypothermia
Patients randomized to the Hypothermia arm (esophageal temp 33º to 34 °C) will be cooled rapidly using the cooling protocol developed for the Hypothermia Paediatric Head Injury Trial. A temperature probe will be placed in the esophagus and its position confirmed using a chest radiograph. Patients will be 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 reaches 34.0ºC, the ice and second cooling blanket will be removed and esophageal temperature will be maintained at 33º to 34 °C for 48 hours using the servo-controlled cooling mattress. Patients treated with ECMO will be cooled using the extracorporeal circuit cooling-device. Rewarming will be done at a rate of 0.5 ºC every 2 hours until an esophageal temperature of 36.5 ºC is reached. Thereafter temperature will be recorded but not controlled by surface cooling.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Cognitive and motor measures [ Time Frame: Assessed at 12 months post-arrest ]
  2. Mortality [ Time Frame: Assessed at 1, 3, 6, and 12 months post-arrest ]
  3. Cerebral edema [ Time Frame: 12 months ]
  4. Adverse effects of hypothermia therapy [ Time Frame: 12 months ]

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00754481

Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada
Canada, Quebec
Sainte-Justine Hospital
Montreal, Quebec, Canada
New Zealand
Starship Children's Hospital
Auckland, New Zealand
United Kingdom
Great Ormond Street Hospital
London, United Kingdom
Sponsors and Collaborators
The Hospital for Sick Children
Principal Investigator: Jamie Hutchison, MD The Hospital for Sick Children

Responsible Party: Jamie Hutchison, Staff Physician, The Hospital for Sick Children Identifier: NCT00754481     History of Changes
Other Study ID Numbers: 1000004888
First Posted: September 18, 2008    Key Record Dates
Last Update Posted: July 31, 2015
Last Verified: July 2015

Keywords provided by Jamie Hutchison, The Hospital for Sick Children:

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms