Hypothermia for Cardiac Arrest in Paediatrics - Full Text View

Sponsor:	The Hospital for Sick Children
Information provided by:	The Hospital for Sick Children
ClinicalTrials.gov Identifier:	NCT00754481

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 II

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:

MedlinePlus related topics: Cardiac Arrest Hypothermia

U.S. FDA Resources

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.

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

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 February 09, 2012