Cardiac Arrest With Successful ResuscitationNCT06207942
Stepcare Extended Follow-up Substudy
A study testing High MAP, Deep sedation and Low MAP in people with Cardiac Arrest With Successful Resuscitation and Hypoxia, Brain, run by Region Skane at 34 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest With Successful Resuscitation, Hypoxia, Brain, Cognitive Impairment
- What is being tested?
- High MAP, Deep sedation and Low MAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 34 sitesin 10 countries
- Study dates
- 1 Aug 2023to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
- 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.
Trial locations and contacts
34 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
34 sites in 10 countries
Australia8 sites, 8 recruiting
- Recruiting
Princess Alexandra Hospital
Brisbane
James Walsham
- Recruiting
The Sutherland Hospital
Caringbah
Frances Bass
- Recruiting
The Prince Charles Hospital
Chermside
Frances Bass
- Recruiting
Nepean hospital
Kingswood
Ian Seppelt, Dr
- Recruiting
St George hospital
Kogarah
- Recruiting
Liverpool hospital
Liverpool
Anthony Stewart, Dr
- Recruiting
Austin hospital
Melbourne
- Recruiting
Royal North Shore Hospital
Sydney
Frances Bass
Sweden5 sites, 5 recruiting
- Recruiting
Sahlgrenska university hospital
Gothenburg
Jonathan Oras
Andreas Lundin
- Recruiting
Hallands hospital
Hålland
Johan Unden, MD PhD
- Recruiting
Helsingborg hospital
Helsingborg
Jesper Johnsson, MD, PhD
- Recruiting
Skåne university hospital
Lund
Anna Lybeck, MD, PhD
- Recruiting
Skåne university hopsital
Malmö
Joachim During, MD, PhD
New Zealand4 sites, 4 recruiting
- Recruiting
Auckland city hospital
Auckland
- Recruiting
Middlemore hospital
Auckland
Paul Young
- Recruiting
Christchurch hospital
Christchurch
Paul Young
- Recruiting
Wellington hospital
Wellington
Paul Young
United Kingdom4 sites, 4 recruiting
- Recruiting
The Essex Cardiothoracic Centre
Basildon
Thomas Keeble
- Recruiting
Bristol Royal Infirmary
Bristol
Matthew Thomas
- Recruiting
University hospital of Wales
Cardiff
Matt Wise
- Recruiting
St Bartholomew's hospital
London
Nikolaos Gorgoraptis
Finland3 sites, 3 recruiting
- Recruiting
Helsinki Helsingfors university central hospital
Helsinki
Marjaana Tiainen
- Recruiting
Jorvi hospital
Jorvi
- Recruiting
Tampere university hospital
Tampere
Joonas Tirkkonen
Germany3 sites, 3 recruiting
- Recruiting
Charite university hospital
Berlin
Christoph Leithner
- Recruiting
Universitäres Herzzentrum Lübeck Universitätsklinikum Schleswig-Holstein
Lübeck
Tobias Graf
- Recruiting
Tubingen university hospital
Tübingen
Belgium2 sites, 2 recruiting
- Recruiting
Ziekenhuis Oost Limburg
Genk
- Recruiting
Ghent university hospital
Ghent
Patrick Druwve
Norway2 sites, 2 recruiting
- Recruiting
Sorlandet hospital
Arendal
- Recruiting
Oslo university hospital Rikshospitalet
Oslo
Louis Romundstad
Switzerland2 sites, 2 recruiting
- Recruiting
Bern university hospital
Bern
Manuela Itens
- Recruiting
Kantonsspital St. Gallen
Sankt Gallen
Claudia Schrag
Luxembourg1 site, 1 recruiting
- Recruiting
Centre Hospitalier de Luxembourg
Luxembourg
Pascal Stammet, MD, PhD
About this study
Official title: Extended Follow-up Substudy of the Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation -STEPCARE Trial
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.
Read the detailed description
This extended follow-up substudy is incorporated into the multi-center, international, factorial randomized Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation -STEPCARE trial (Clinical trials identifier:NCT05564754) were out of hospital cardiac arrest participants will be randomized to different targets of sedation, temperature, and MAP management.
Only selected STEPCARE sites will participate in this extended follow-up substudy. At the extended follow up participating sites all out of hospital cardiac arrest participants randomized in the STEPCARE trial, who survive and provide consent, will be eligible to participate in this substudy, with no further inclusion or exclusion criteria.The extended follow-up substudy is estimated to enroll approximately 600 post OHCA survivors. One nominated caregiver per post OHCA survivor will be invited to be included in the study.
Participants will be followed up at 6 and 12 months.
The primary outcome for this extended follow up substudy is cognitive function at 6 months for the out of hospital cardiac arrest survivors andCaregiver burden at 6 months for the caregivers.
- Conditions
- Cardiac Arrest With Successful Resuscitation, Hypoxia, Brain, Cognitive Impairment, Caregiver Burden
- Being tested
- Feed back controlled temperature device, High MAP, Deep sedation, Fever control without a device, Low MAP
- Medical subject headings
- Hypoxia, Brain, Cognitive Dysfunction, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feed back controlled temperature deviceDevice
If core temperature exceeds 37.7 degrees celsius a feedback controlled-device will be used at set to 37.5 degrees celsius
High MAPOther
A mean arterial blood pressure (MAP) of >85mmHg will be used. Vasopressors will be titrated to this target during 36 hours
Deep sedationOther
Deep sedation for at least 36 hours
Fever control without a deviceOther
Management of fever in the intensive care unit without a device
Low MAPOther
A mean arterial blood pressure (MAP) of >65mmHG will be used. Vasopressors will be titrated to this target during 36 hours
Minimal sedationOther
A strategy of minimal sedation in the intensive care unit, used only as needed to facilitate transport, imaging and invasive procedures
| Study group | Role | What they receive |
|---|---|---|
| Sedation, temperature device and high MAP | Active comparator | Not described Receives: Device: Feed back controlled temperature device; Other: High MAP; Other: Deep sedation |
| Sedation, no temperature device and high MAP | Active comparator | Not described Receives: Other: High MAP; Other: Deep sedation; Other: Fever control without a device |
| Sedation, temperature device and low MAP | Active comparator | Not described Receives: Device: Feed back controlled temperature device; Other: Deep sedation; Other: Low MAP |
| Sedation, no temperature device, and low MAP | Active comparator | Not described Receives: Other: Deep sedation; Other: Fever control without a device; Other: Low MAP |
| Minimal sedation, temperature device, and high MAP | Active comparator | Not described Receives: Device: Feed back controlled temperature device; Other: High MAP; Other: Minimal sedation |
| Minimal sedation, no temperature device and high MAP | Active comparator | Not described Receives: Other: High MAP; Other: Fever control without a device; Other: Minimal sedation |
| Minimal sedation, temperature device and low MAP | Active comparator | Not described Receives: Device: Feed back controlled temperature device; Other: Low MAP; Other: Minimal sedation |
| Minimal sedation, no temperature device and low MAP | Active comparator | Not described Receives: Other: Fever control without a device; Other: Low MAP; Other: Minimal sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment (MoCA)
Cognitive function for out of hospital cardiac arrest survivors. Score range. Higher scores=better cognition
Measured: 6 months
Zarit Burden Interview (ZBI)
Caregiver burden for caregivers to out of hospital cardiac arrest survivors. Score range 0-88. Higher scores= worse indicating more caregiver burden
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start1 Aug 2023
- Primary completionJan 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Arrest With Successful ResuscitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2X2X2 factorial., with all participants taking part in each factor
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University, The George Institute for Global Health, Australia, Copenhagen Trial Unit, Center for Clinical Intervention Research, Helsinki University Central Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207942
- Sponsor's protocol ID
- extfustep2024
- Status last verified
- Apr 2025
- First submitted
- 5 Jan 2024
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Upon resonable request following publication
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Follow-up Substudy of the Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation -STEPCARE Trial
- ClinicalTrials.gov ID
- NCT06207942
- Acronym / sponsor ID
- extfustep2024
- Conditions
- Cardiac Arrest With Successful Resuscitation, Hypoxia, Brain, Cognitive Impairment, Caregiver Burden
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University, The George Institute for Global Health, Australia, Copenhagen Trial Unit, Center for Clinical Intervention Research, Helsinki University Central Hospital
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 17 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This extended follow-up substudy is incorporated into the multi-center, international, factorial randomized Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation -STEPCARE trial (Clinical trials identifier:NCT05564754) were out of hospital cardiac arrest participants will be randomized to different targets of sedation, temperature, and MAP management.
Only selected STEPCARE sites will participate in this extended follow-up substudy. At the extended follow up participating sites all out of hospital cardiac arrest participants randomized in the STEPCARE trial, who survive and provide consent, will be eligible to participate in this substudy, with no further inclusion or exclusion criteria.The extended follow-up substudy is estimated to enroll approximately 600 post OHCA survivors. One nominated caregiver per post OHCA survivor will be invited to be included in the study.
Participants will be followed up at 6 and 12 months.
The primary outcome for this extended follow up substudy is cognitive function at 6 months for the out of hospital cardiac arrest survivors andCaregiver burden at 6 months for the caregivers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 8
- Model description
- 2X2X2 factorial., with all participants taking part in each factor
| Arm | Type | Receives |
|---|---|---|
| Sedation, temperature device and high MAP | Active comparator | Device: Feed back controlled temperature device, Other: High MAP, Other: Deep sedation |
| Sedation, no temperature device and high MAP | Active comparator | Other: High MAP, Other: Deep sedation, Other: Fever control without a device |
| Sedation, temperature device and low MAP | Active comparator | Device: Feed back controlled temperature device, Other: Deep sedation, Other: Low MAP |
| Sedation, no temperature device, and low MAP | Active comparator | Other: Deep sedation, Other: Fever control without a device, Other: Low MAP |
| Minimal sedation, temperature device, and high MAP | Active comparator | Device: Feed back controlled temperature device, Other: High MAP, Other: Minimal sedation |
| Minimal sedation, no temperature device and high MAP | Active comparator | Other: High MAP, Other: Fever control without a device, Other: Minimal sedation |
| Minimal sedation, temperature device and low MAP | Active comparator | Device: Feed back controlled temperature device, Other: Low MAP, Other: Minimal sedation |
| Minimal sedation, no temperature device and low MAP | Active comparator | Other: Fever control without a device, Other: Low MAP, Other: Minimal sedation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feed back controlled temperature deviceIf core temperature exceeds 37.7 degrees celsius a feedback controlled-device will be used at set to 37.5 degrees celsius | Device | Minimal sedation, temperature device and low MAP, Minimal sedation, temperature device, and high MAP, Sedation, temperature device and high MAP, Sedation, temperature device and low MAP |
| High MAPA mean arterial blood pressure (MAP) of >85mmHg will be used. Vasopressors will be titrated to this target during 36 hours | Other | Minimal sedation, no temperature device and high MAP, Minimal sedation, temperature device, and high MAP, Sedation, no temperature device and high MAP, Sedation, temperature device and high MAP |
| Deep sedationDeep sedation for at least 36 hours | Other | Sedation, no temperature device and high MAP, Sedation, no temperature device, and low MAP, Sedation, temperature device and high MAP, Sedation, temperature device and low MAP |
| Fever control without a deviceManagement of fever in the intensive care unit without a device | Other | Minimal sedation, no temperature device and high MAP, Minimal sedation, no temperature device and low MAP, Sedation, no temperature device and high MAP, Sedation, no temperature device, and low MAP |
| Low MAPA mean arterial blood pressure (MAP) of >65mmHG will be used. Vasopressors will be titrated to this target during 36 hours | Other | Minimal sedation, no temperature device and low MAP, Minimal sedation, temperature device and low MAP, Sedation, no temperature device, and low MAP, Sedation, temperature device and low MAP |
| Minimal sedationA strategy of minimal sedation in the intensive care unit, used only as needed to facilitate transport, imaging and invasive procedures | Other | Minimal sedation, no temperature device and high MAP, Minimal sedation, no temperature device and low MAP, Minimal sedation, temperature device and low MAP, Minimal sedation, temperature device, and high MAP |
Primary outcome
Montreal Cognitive Assessment (MoCA)
Time frame: 6 months
Cognitive function for out of hospital cardiac arrest survivors. Score range. Higher scores=better cognition
Zarit Burden Interview (ZBI)
Time frame: 6 months
Caregiver burden for caregivers to out of hospital cardiac arrest survivors. Score range 0-88. Higher scores= worse indicating more caregiver burden
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Official STEPCARE trial websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Upon resonable request following publication
Related trials for Cardiac Arrest With Successful Resuscitation
Active, not recruiting
Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation
Cardiac Arrest With Successful Resuscitation, Hypoxia, Brain
Enrolling by invitationObservational study
A Study on the Impact of a New Canton-Wide First Responder System in Zug, Switzerland, on Survival After Adult Cardiac Arrest-Examining Early Life-Saving Organized Help, Fast Defibrillation, and Improved Outcomes for Out of Hospital Cardiac Arrest
Cardiac Arrest (CA), Cardiac Arrest With Successful Resuscitation
RecruitingPhase 2
CardioPulmonary Resuscitation With Argon (CPAr) Trial
Cardiac Arrest, Out-Of-Hospital, Cardiac Arrest With Successful Resuscitation
RecruitingObservational study
Optimization of Transport and Use of a Mobile ECMO Team in Patients With Sudden Cardiac Arrest in the Moravian-Silesian Region
Cardiac Arrest With Successful Resuscitation, Cardiac Arrest, Cause Unspecified
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Study of Ventilator Associated Event During Intensive Care After Resuscitated Cardiac Arrest.
Cardiac Arrest With Successful Resuscitation, Mechanical Ventilation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
34 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High MAP, Deep sedation and Low MAP in people with Cardiac Arrest With Successful Resuscitation and Hypoxia, Brain, run by Region Skane at 34 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Australia, Sweden, New Zealand, United Kingdom, Finland and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gisela Lilja, PhD (+4646176393, gisela.lilja@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment (MoCA) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.