Hypothermia for Cardiac Arrest in Paediatrics

NCT00754481 | Completed Phase 2 DMC

• 1 other identifier: 1000004888
• Study Type: interventional
• Target: 38
• Locations: 3 countries
• Sites: 4

Brief 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

Keywords

Paediatrics

Outcome Measures

Primary Outcomes (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

  Assessed at 12 months post cardiac arrest

Secondary Outcomes (4)

• Cognitive and motor measures

  Assessed at 12 months post-arrest

• Mortality

  Assessed at 1, 3, 6, and 12 months post-arrest

• Cerebral edema

  12 months

• Adverse effects of hypothermia therapy

  12 months

Study Arms (2)

1

ACTIVE COMPARATOR

Other: Normothermia

2

EXPERIMENTAL

Other: Hypothermia

Interventions

Normothermia OTHER

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.

1

Hypothermia OTHER

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.

2

Eligibility Criteria

• Age: 1 Day - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (4)

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

Sainte-Justine Hospital

Montreal, Quebec, Canada

Location

Starship Children's Hospital

Auckland, New Zealand

Location

Great Ormond Street Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Jamie Hutchison, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: September 17, 2008
• First Posted: September 18, 2008
• Study Start: January 1, 2005
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2010
• Last Updated: July 14, 2021

Record last verified: 2021-07

Locations

NZ (1); CA (2); GB (1)