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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03743584




Registration number
NCT03743584
Ethics application status
Date submitted
6/11/2018
Date registered
16/11/2018
Date last updated
20/09/2021

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
The on-going randomized clinical trial TTM2 (Target Hypothermia Versus Targeted Normothermia
After Out-of-hospital Cardiac Arrest, NCT02908308) investigates if there is a difference in
mortality, neurological function or quality of life in comatose survivors after
out-of-hospital cardiac arrest if treated (Group A) at target temperature of 33 oC or (Group
B) by avoiding fever during the first 24 h.

In this sub study, the effect of different target temperatures on cardiac and circulatory
physiology is evaluated by echocardiography and pulmonary artery catheter. Tissue damage
after cardiac arrest in part is caused by an activation of different parts of the
inflammatory system (reperfusion injury). This study investigates the effect of temperature
management on inflammation and the link to the circulatory effects.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03743584
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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