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Hypothermia for Cardiac Arrest in Paediatrics

Primary Purpose

Cardiac Arrest

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Normothermia
Hypothermia
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring Paediatrics

Eligibility Criteria

1 Day - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Hospital for Sick Children
  • Sainte-Justine Hospital
  • Starship Children's Hospital
  • Great Ormond Street Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Outcomes

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

Secondary Outcome Measures

Cognitive and motor measures
Mortality
Cerebral edema
Adverse effects of hypothermia therapy

Full Information

First Posted
September 17, 2008
Last Updated
July 8, 2021
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT00754481
Brief Title
Hypothermia for Cardiac Arrest in Paediatrics
Official Title
Hypothermia for Cardiac Arrest in Paediatrics (HypCAP) - Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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 completed 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. This protocol was used to develop the protocol for the THAPCA trials (see 2 manuscripts published Moler et al NEJM 2015 and 2017 and multiple other manuscripts). Hypothermia therapy, compared to active maintenance of normothermia, had no beneficial effect on functional outcome or mortality in children with out-of-hospital or in-hospital cardiac arrest.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
Paediatrics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Normothermia
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Hypothermia
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Cognitive and motor measures
Time Frame
Assessed at 12 months post-arrest
Title
Mortality
Time Frame
Assessed at 1, 3, 6, and 12 months post-arrest
Title
Cerebral edema
Time Frame
12 months
Title
Adverse effects of hypothermia therapy
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamie Hutchison, MD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Sainte-Justine Hospital
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Starship Children's Hospital
City
Auckland
Country
New Zealand
Facility Name
Great Ormond Street Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

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Hypothermia for Cardiac Arrest in Paediatrics

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