Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00754481




Registration number
NCT00754481
Ethics application status
Date submitted
17/09/2008
Date registered
18/09/2008
Date last updated
14/07/2021

Titles & IDs
Public title
Hypothermia for Cardiac Arrest in Paediatrics
Scientific title
Hypothermia for Cardiac Arrest in Paediatrics (HypCAP) - Pilot Study
Secondary ID [1] 0 0
1000004888
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac Arrest 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Normothermia
Other interventions - Hypothermia

Active comparator: 1 -

Experimental: 2 -


Other interventions: Normothermia
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.

Other interventions: Hypothermia
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Assessed at 12 months post cardiac arrest
Secondary outcome [1] 0 0
Cognitive and motor measures
Timepoint [1] 0 0
Assessed at 12 months post-arrest
Secondary outcome [2] 0 0
Mortality
Timepoint [2] 0 0
Assessed at 1, 3, 6, and 12 months post-arrest
Secondary outcome [3] 0 0
Cerebral edema
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
Adverse effects of hypothermia therapy
Timepoint [4] 0 0
12 months

Eligibility
Key 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
Minimum age
1 Day
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2010
Sample size
Target
Accrual to date
Final
38
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario
Country [2] 0 0
Canada
State/province [2] 0 0
Quebec
Country [3] 0 0
New Zealand
State/province [3] 0 0
Auckland
Country [4] 0 0
United Kingdom
State/province [4] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
The Hospital for Sick Children
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jamie Hutchison, MD
Address 0 0
The Hospital for Sick Children
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00754481