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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
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.
Trial website
https://clinicaltrials.gov/study/NCT00754481
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00754481