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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05564754




Registration number
NCT05564754
Ethics application status
Date submitted
29/09/2022
Date registered
3/10/2022
Date last updated
19/03/2024

Titles & IDs
Public title
Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation
Scientific title
Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation
Secondary ID [1] 0 0
step2022
Universal Trial Number (UTN)
Trial acronym
STEPCARE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac Arrest With Successful Resuscitation 0 0
Hypoxia, Brain 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Feedback-controlled temperature device
Other interventions - High MAP
Other interventions - Deep sedation
Other interventions - Fever control without a device
Other interventions - Low MAP
Other interventions - Minimal sedation

Active comparator: Sedation, temperature device and high MAP - Continuous deep sedation for 36 hours Fever management with a feedback-controlled device if temperature above 37.7°C. A mean arterial pressure target of \>85mmHg.

Active comparator: Sedation, no temperature device and high MAP - Continuous deep sedation for 36 hours. Fever management without a feedback-controlled device. A mean arterial pressure target of \>85mmHg.

Active comparator: Sedation, temperature device and low MAP - Continuous deep sedation for 36 hours. Fever management with a feedback-controlled device if temperature above 37.7°C. A mean arterial pressure target of \>65mmHg.

Active comparator: Sedation, no temperature device and low MAP - Continuous deep sedation for 36 hours. Fever management without a feedback-controlled device. A mean arterial pressure target of \>65mmHg.

Active comparator: Minimal sedation, temperature device and high MAP - Minimal sedation (and early extubation if possible). Fever management with a feedback-controlled device if temperature above 37.7°C. A mean arterial pressure target of \>85mmHg.

Active comparator: Minimal sedation, no temperature device and high MAP - Minimal sedation (and early extubation if possible). Fever management without a feedback-controlled device. A mean arterial pressure target of \>65mmHg.

Active comparator: Minimal sedation, temperature device and low MAP - Minimal sedation (and early extubation if possible). Fever management with a feedback-controlled device if temperature above 37.7°C. A mean arterial pressure target of \>65mmHg.

Active comparator: Minimal sedation, no temperature device and low MAP - Minimal sedation (and early extubation if possible). Fever management without a feedback-controlled device. A mean arterial pressure target of \>65mmHg.


Treatment: Devices: Feedback-controlled temperature device
If core body temperature exceeds 37.7°C a feedback controlled-device will be used and set at 37.5°C.

Other interventions: High MAP
A MAP target of \>85mmHg will be used. Vasopressors will be titrated to this target during 36h.

Other interventions: Deep sedation
Deep sedation for at least 36h

Other interventions: Fever control without a device
Management of fever in the ICU without a device

Other interventions: Low MAP
A MAP target of \>65mmHg will be used. Vasopressors will be titrated to this target during 36h.

Other interventions: Minimal sedation
A strategy of minimal sedation in the ICU, used only as needed to facilitate transport, imaging and invasive procedures.
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mortality
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Functional outcome
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Health-related quality of life
Timepoint [2] 0 0
6 months

Eligibility
Key inclusion criteria
1. Out-of-hospital cardiac arrest
2. Sustained ROSC - defined as 20 minutes with signs of circulation without the need for chest compressions
3. Unconsciousness defined as not being able to obey verbal commands (FOUR-score motor response of <4) or being intubated and sedated because of agitation after sustained ROSC.
4. Eligible for intensive care without restrictions or limitations
5. Inclusion within 4 hours of ROSC
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. On ECMO prior to randomization
2. Pregnancy
3. Suspected or confirmed intracranial hemorrhage
4. Previously randomized in the STEPCARE trial.

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
Factorial
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
3500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
John Hunter Hospital - Newcastle
Recruitment hospital [4] 0 0
Concord Repatriation Hospital - Sydney
Recruitment hospital [5] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [6] 0 0
St George Hospital - Sydney
Recruitment hospital [7] 0 0
The Sutherland Hospital - Sydney
Recruitment hospital [8] 0 0
Westmead Hospital - Westmead
Recruitment hospital [9] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [10] 0 0
The Prince Charles Hospital - Brisbane
Recruitment hospital [11] 0 0
Northern Hospital - Epping
Recruitment hospital [12] 0 0
Austin Hospital - Melbourne
Recruitment hospital [13] 0 0
The Victorian Heart Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Kingswood
Recruitment postcode(s) [2] 0 0
- Liverpool
Recruitment postcode(s) [3] 0 0
- Newcastle
Recruitment postcode(s) [4] 0 0
- Sydney
Recruitment postcode(s) [5] 0 0
- Westmead
Recruitment postcode(s) [6] 0 0
- Brisbane
Recruitment postcode(s) [7] 0 0
- Epping
Recruitment postcode(s) [8] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Finland
State/province [1] 0 0
Espoo
Country [2] 0 0
Finland
State/province [2] 0 0
Helsinki
Country [3] 0 0
Finland
State/province [3] 0 0
Kuopio
Country [4] 0 0
Finland
State/province [4] 0 0
Oulu
Country [5] 0 0
Finland
State/province [5] 0 0
Tampere
Country [6] 0 0
Germany
State/province [6] 0 0
Lübeck
Country [7] 0 0
Luxembourg
State/province [7] 0 0
Luxembourg
Country [8] 0 0
New Zealand
State/province [8] 0 0
Christchurch
Country [9] 0 0
New Zealand
State/province [9] 0 0
Wellington
Country [10] 0 0
Sweden
State/province [10] 0 0
Halland
Country [11] 0 0
Sweden
State/province [11] 0 0
Skåne
Country [12] 0 0
Sweden
State/province [12] 0 0
Gothenburg
Country [13] 0 0
Sweden
State/province [13] 0 0
Solna
Country [14] 0 0
Switzerland
State/province [14] 0 0
Saint Gallen
Country [15] 0 0
Switzerland
State/province [15] 0 0
Zürich

Funding & Sponsors
Primary sponsor type
Other
Name
Region Skane
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Lund University, Lund, Sweden
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Copenhagen Trial Unit, Center for Clinical Intervention Research
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
The George Institute for Global Health, Australia
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
HUS Helsinki University Hospitals, Helsinki, Finland
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Medical Research Institute of New Zealand Rangahautia Te Ora, Wellington, New Zealand
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The STEPCARE-trial is a 2x2x2 randomised trial studying patients who have been resuscitated from cardiac arrest and who are comatose. It will include three different interventions focusing on sedation targets, temperature targets and mean arterial pressure targets.
Trial website
https://clinicaltrials.gov/study/NCT05564754
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Niklas Nielsen, PhD
Address 0 0
Lund University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Josef Dankiewicz, PhD
Address 0 0
Country 0 0
Phone 0 0
+464671000
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05564754