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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03743584




Registration number
NCT03743584
Ethics application status
Date submitted
6/11/2018
Date registered
16/11/2018

Titles & IDs
Public title
Hypothermia After Cardiac Arrest - Effects on Myocardial Function and Inflammatory Response.
Scientific title
Hypothermia After Cardiac Arrest - Effects on Myocardial Function and Inflammatory Response.
Secondary ID [1] 0 0
2018/1057 C
Universal Trial Number (UTN)
Trial acronym
IH3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Out of Hospital Cardiac Arrest 0 0
Inflammatory Response 0 0
Ischemia Reperfusion Injury 0 0
Hypothermia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Targeted temperature management
Treatment: Surgery - Standard care, early treatment of fever

Experimental: Targeted temperature management at 33°C - Cooling and temperature control at 33°C, according to the study protocol of the TTM2-trial

Active comparator: Standard care, early treatment of fever - Standard of care and normothermia. If temperature 37,8 °C or above use of device for temperature control.


Treatment: Surgery: Targeted temperature management
Target temperature management at 33°C

Treatment: Surgery: Standard care, early treatment of fever
Standard of care with early treatment of fever
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in wall motion score
Timepoint [1] 0 0
48 hours , 72 hours, 6 months
Primary outcome [2] 0 0
Plasma concentration of inflammatory markers
Timepoint [2] 0 0
48 hours , 72 hours, 6 months
Secondary outcome [1] 0 0
Association between inflammatory response and cardiac function
Timepoint [1] 0 0
48 hours , 72 hours, 6 months

Eligibility
Key inclusion criteria
* Included in the TTM2-trial and treated at the Intensive Care Unit at Rikshospitalet, Oslo
* Out-of-hospital cardiac arrest of a presumed cardiac or unknown cause
* Sustained ROSC - de?ned as 20 minutes with signs of circulation without the need for chest compressions.
* Unconsciousness de?ned as not being able to obey verbal commands (FOUR-score motor response of <4) and no verbal response to pain after sustained ROSC.
* Eligible for intensive care without restrictions or limitations
* Inclusion within 180 minutes of ROSC
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Not included in the TTM2-trial
* Unwitnessed cardiac arrest with an initial rhythm of asystole
* Temperature on admission <30°C.
* On ECMO prior to ROSC
* Obvious or suspected pregnancy
* Intracranial bleeding
* Severe chronic obstructive pulmonary disorder (COPD) with long-term home oxygen therapy"

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 receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
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
8/11/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/07/2020
Sample size
Target
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Norway
State/province [1] 0 0
Oslo

Funding & Sponsors
Primary sponsor type
Other
Name
Oslo University Hospital
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Søren Pischke, MD, PhD
Address 0 0
Oslo University Hospital, Oslo, Norway
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

Data sharing statement


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/NCT03743584