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/ct2/show/NCT06207942




Registration number
NCT06207942
Ethics application status
Date submitted
5/01/2024
Date registered
17/01/2024
Date last updated
3/06/2024

Titles & IDs
Public title
Stepcare Extended Follow-up Substudy
Scientific title
Extended Follow-up Substudy of the Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation -STEPCARE Trial
Secondary ID [1] 0 0
extfustep2024
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac Arrest With Successful Resuscitation 0 0
Hypoxia, Brain 0 0
Cognitive Impairment 0 0
Caregiver Burden 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
Public Health 0 0 0 0
Other public health
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Feed back 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 -

Active Comparator: Sedation, no temperature device and high MAP -

Active Comparator: Sedation, temperature device and low MAP -

Active Comparator: Sedation, no temperature device, and low MAP -

Active Comparator: Minimal sedation, temperature device, and high MAP -

Active Comparator: Minimal sedation, no temperature device and high MAP -

Active Comparator: Minimal sedation, temperature device and low MAP -

Active Comparator: Minimal sedation, no temperature device and low MAP -


Treatment: Devices: Feed back controlled temperature device
If core temperature exceeds 37.7 degrees celsius a feedback controlled-device will be used at set to 37.5 degrees celsius

Other interventions: High MAP
A mean arterial blood pressure (MAP) of >85mmHg will be used. Vasopressors will be titrated to this target during 36 hours

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

Other interventions: Fever control without a device
Management of fever in the intensive care unit without a device

Other interventions: Low MAP
A mean arterial blood pressure (MAP) of >65mmHG will be used. Vasopressors will be titrated to this target during 36 hours

Other interventions: Minimal sedation
A strategy of minimal sedation in the intensive care unit, 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
Montreal Cognitive Assessment (MoCA)
Timepoint [1] 0 0
6 months
Primary outcome [2] 0 0
Zarit Burden Interview (ZBI)
Timepoint [2] 0 0
6 months

Eligibility
Key inclusion criteria
All OHCA participants randomized in the STEPCARE trial at the extended follow-up
participating sites, who survive and provide consent, with no further inclusion or
exclusion criteria.

The inclusion and exclusion criteria for the STEPCARE trial are:

- Inclusion criteria: out-of-hospital cardiac arrest of non-traumatic origin, minimum of
20 minutes without chest compressions (defined as stable return of spontaneous
circulation. ROSC), unconsciousness (defined as not being able to obey verbal commands
equal to a FOUR-score motor response of <4, or being intubated and sedated because of
agitation after sustained ROSC, eligible for intensive care without restrictions or
limitation, inclusion within 4 hours (240 minutes) of ROSC (or 220 minutes of stable
ROSC).

-
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: on ECMO prior to randomization, pregnancy, suspected or confirmed
intracranial hemorrhage, previously randomized in the STEPCARE trial.

For caregivers, the eligibility will be that they live with, or have weekly or more
frequent contact (in person or over the telephone) with the post OHCA survivor. Only one
nominated caregiver per post OHCA survivor will be able to be included in the study. This
would typically be the caregiver that would identify as the primary caregiver of the post
OHCA survivor if needed, but may also be another close family member.

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
1/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [2] 0 0
The Sutherland Hospital - Caringbah
Recruitment hospital [3] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [4] 0 0
Nepean hospital - Kingswood
Recruitment hospital [5] 0 0
Liverpool hospital - Liverpool
Recruitment hospital [6] 0 0
Royal North Shore Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment postcode(s) [2] 0 0
- Caringbah
Recruitment postcode(s) [3] 0 0
- Chermside
Recruitment postcode(s) [4] 0 0
- Kingswood
Recruitment postcode(s) [5] 0 0
- Liverpool
Recruitment postcode(s) [6] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Finland
State/province [1] 0 0
Helsinki
Country [2] 0 0
Finland
State/province [2] 0 0
Tampere
Country [3] 0 0
Germany
State/province [3] 0 0
Lübeck
Country [4] 0 0
Luxembourg
State/province [4] 0 0
Luxembourg
Country [5] 0 0
New Zealand
State/province [5] 0 0
Auckland
Country [6] 0 0
New Zealand
State/province [6] 0 0
Christchurch
Country [7] 0 0
New Zealand
State/province [7] 0 0
Wellington
Country [8] 0 0
Norway
State/province [8] 0 0
Oslo
Country [9] 0 0
Sweden
State/province [9] 0 0
Gothenburg
Country [10] 0 0
Sweden
State/province [10] 0 0
Halland
Country [11] 0 0
Sweden
State/province [11] 0 0
Helsingborg
Country [12] 0 0
Sweden
State/province [12] 0 0
Lund
Country [13] 0 0
Sweden
State/province [13] 0 0
Malmö
Country [14] 0 0
Switzerland
State/province [14] 0 0
Saint Gallen
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Cardiff

Funding & Sponsors
Primary sponsor type
Other
Name
Region Skane
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Lund University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The George Institute for Global Health, Australia
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Copenhagen Trial Unit, Center for Clinical Intervention Research
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Helsinki University Central Hospital
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
To provide detailed information on long-term outcomes in relation to potential
neuroprotection and improvements in recovery for different targets of sedation, temperature,
and pressure management in post out of hospital cardiac arrest survivors at 6 and 12 months.
In addition, the impact of caring for a post OHCA survivor will be explored.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06207942
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Gisela Lilja, PhD
Address 0 0
Country 0 0
Phone 0 0
+4646176393
Fax 0 0
Email 0 0
gisela.lilja@med.lu.se
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06207942