Hypothermia for Cardiac Arrest in Paediatrics

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by The Hospital for Sick Children.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00754481
First received: September 17, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  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.


Condition Intervention Phase
Cardiac Arrest
Other: Normothermia
Other: Hypothermia
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hypothermia for Cardiac Arrest in Paediatrics (HypCAP) - Pilot Study

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cognitive and motor measures [ Time Frame: Assessed at 12 months post-arrest ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: Assessed at 1, 3, 6, and 12 months post-arrest ] [ Designated as safety issue: Yes ]
  • Cerebral edema [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Adverse effects of hypothermia therapy [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: January 2005
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754481

Locations
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada
Contact: Jamie Hutchison, MD    (416)813-7654 ext 4918    jamie.hutchison@sickkids.ca   
Principal Investigator: Jamie Hutchison, MD         
Canada, Quebec
Sainte-Justine Hospital Recruiting
Montreal, Quebec, Canada
Contact: Marissa Tucci, MD       marisa.tucci@recherche-ste-justine.qc.ca   
Principal Investigator: Marissa Tucci, MD         
New Zealand
Starship Children's Hospital Recruiting
Auckland, New Zealand
Contact: John Beca, MD       JohnBeca@adhb.govt.nz   
Principal Investigator: John Beca, MD         
United Kingdom
Great Ormond Street Hospital Recruiting
London, United Kingdom
Contact: Aparna Hoskote, MD       HoskoA@gosh.nhs.uk   
Principal Investigator: Aparna Hoskote, MD         
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Jamie Hutchison, MD The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Jamie Hutchison/Principal Investigator, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00754481     History of Changes
Other Study ID Numbers: 1000004888
Study First Received: September 17, 2008
Last Updated: September 17, 2008
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
Paediatrics

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

ClinicalTrials.gov processed this record on September 22, 2014