Cardiac Arrest With Successful ResuscitationSTEPCARENCT05564754
Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation
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 56 sites in 15 countries.
Trial 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. 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
- 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
- 3,500 participants
- Where
- 56 sitesin 15 countries
- Study dates
- 17 Aug 2023to Mar 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
Who may be able to join
- Out-of-hospital cardiac arrest
- Sustained ROSC - defined as 20 minutes with signs of circulation without the need for chest compressions
- 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.
- Eligible for intensive care without restrictions or limitations
- Inclusion within 4 hours of ROSC
Who cannot join
- On ECMO prior to randomization
- Pregnancy
- Suspected or confirmed intracranial hemorrhage
- Previously randomized in the STEPCARE trial
- Trauma or hemorrhage being the presumed cause of arrest
Trial locations and contacts
56 sites in 15 countries.
56 sites in 15 countries
Sweden9 sites
Sahlgrenska University Hospital
Gothenburg
Hallands hospital
Halmstad, Halland County
Helsingborg Hospital
Helsingborg, Skåne County
Karlstad hospital
Karlstad
Skåne University Hospital
Lund, Skåne County
Skåne University Hospital Malmö
Malmö, Skåne County
Skaraborg Hospital Skovde
Skövde
Karolinska University Hospital
Stockholm
University Hospital of Umeå
Umeå
Australia8 sites
Princess Alexandra Hospital
Brisbane, Queensland
The Prince Charles Hospital
Brisbane, Queensland
Nepean Hospital
Kingswood, New South Wales
Liverpool Hospital
Liverpool, New South Wales
Austin Hospital
Melbourne, Victoria
Royal North Shore Hospital
Sydney, New South Wales
St George Hospital
Sydney, New South Wales
The Sutherland Hospital
Sydney, New South Wales
Finland7 sites
Jorvi Hospital
Espoo
Meilahti Hospital
Helsinki, 00290
Helsinki Helsingforgs University Central Hospital
Helsinki
Jyväskylä Hospital
Jyväskylä
Kuopio University Hospital
Kuopio
Oulu University Hospital
Oulu
Tampere University Hospital
Tampere
United Kingdom7 sites
Essex Cardiothoracic Centre
Basildon
Bristol Royal Infirmary
Bristol
Cardiff University Hospital
Cardiff
Leeds General Infirmary
Leeds
Kings College Hospital
London
St Bartholomew's Hospital
London
St Georges University Hospital
London
New Zealand6 sites
DCCM ICU
Auckland
Middlemore ICU
Auckland
North Shore ICU NZ
Auckland
Christchurch Hospital
Christchurch
Whangarei ICU
Northland
Wellington Hospital
Wellington
Norway4 sites
Soerlandet Hospital Arendal
Arendal
Kalnes Hospital
Kalnes
Oslo University Hospital
Oslo
Stavanger University Hospital
Stavanger
Belgium3 sites
HUB Hôpital Erasme
Brussels, 1077
Ghent University Hospital
Ghent, 9000
Ziekenhuis Oost-Limburg Hospital
Lanaken, 3620
Germany3 sites
Charite University Hospital
Berlin
Lübeck University Hospital
Lübeck
Tubingen University Hospital
Tübingen
Switzerland3 sites
Bern University Hospital
Bern
St Gallen Hospital
Sankt Gallen
University Hospital Zürich
Zurich
About this study
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.
Read the detailed description
3500 patients who are comatose after cardiac arrest will be included in a trial studying three separate targets. All patients will be randomised to a control or an intervention arm for sedation, temperature and blood pressure targets. These are.
- Continuous deep sedation for 36 hours or minimal sedation (SEDCARE)
- Fever management with or without a feedback-controlled device (TEMPCARE)
- A mean arterial pressure target of >85mmHg or >65mmHg. (MAPCARE)
Participants will be followed up at 30 days and 6 months. The primary outcome will be survival at 6 months.
- Being tested
- Feedback-controlled temperature device, High MAP, Deep sedation, Fever control without a device, Low MAP
- Medical subject headings
- Hypoxia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feedback-controlled temperature deviceDevice
If core body temperature exceeds 37.7°C a feedback controlled-device will be used and set at 37.5°C.
High MAPOther
A MAP target of >85mmHg will be used. Vasopressors will be titrated to this target during 36h.
Deep sedationOther
Deep sedation for at least 36h
Fever control without a deviceOther
Management of fever in the ICU without a device
Low MAPOther
A MAP target of >65mmHg will be used. Vasopressors will be titrated to this target during 36h.
Minimal sedationOther
A strategy of minimal sedation in the ICU, 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 | 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. Receives: Device: Feedback-controlled temperature device; Other: High MAP; Other: Deep sedation |
| Sedation, no temperature device and high MAP | Active comparator | Continuous deep sedation for 36 hours. Fever management without a feedback-controlled device. A mean arterial pressure target of >85mmHg. Receives: Other: High MAP; Other: Deep sedation; Other: Fever control without a device |
| Sedation, temperature device and low MAP | Active comparator | 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. Receives: Device: Feedback-controlled temperature device; Other: Deep sedation; Other: Low MAP |
| Sedation, no temperature device and low MAP | Active comparator | Continuous deep sedation for 36 hours. Fever management without a feedback-controlled device. A mean arterial pressure target of >65mmHg. Receives: Other: Deep sedation; Other: Fever control without a device; Other: Low MAP |
| Minimal sedation, temperature device and high MAP | Active comparator | 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. Receives: Device: Feedback-controlled temperature device; Other: High MAP; Other: Minimal sedation |
| Minimal sedation, no temperature device and high MAP | Active comparator | Minimal sedation (and early extubation if possible). Fever management without a feedback-controlled device. A mean arterial pressure target of >65mmHg. Receives: Other: High MAP; Other: Fever control without a device; Other: Minimal sedation |
| Minimal sedation, temperature device and low MAP | Active comparator | 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. Receives: Device: Feedback-controlled temperature device; Other: Low MAP; Other: Minimal sedation |
| Minimal sedation, no temperature device and low MAP | Active comparator | Minimal sedation (and early extubation if possible). Fever management without a feedback-controlled device. A mean arterial pressure target of >65mmHg. 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.
Mortality
Landmark mortality at follow-up performed at 6 months
Measured: 6 months
Secondary outcomes (2)
Functional outcome
Proportion of patients who have a mRS score of 4-6
Measured: 6 months
Health-related quality of life
EQ5D-5L VAS
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 posted3 Oct 2022
- Study start17 Aug 2023
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Arrest With Successful ResuscitationStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- 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 patients taking part in each factor.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University, Lund, Sweden, Copenhagen Trial Unit, Center for Clinical Intervention Research, The George Institute for Global Health, Australia, HUS Helsinki University Hospitals, Helsinki, Finland, Medical Research Institute of New Zealand Rangahautia Te Ora, Wellington, New Zealand, University Hospital of Wales
- Responsible party
- Sponsor
- Investigators
- Niklas Nielsen, PhD, Study chair, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05564754
- Sponsor's protocol ID
- step2022
- Acronym
- STEPCARE
- Status last verified
- May 2026
- First submitted
- 29 Sep 2022
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Upon reasonable request following publication
Publications
Battaglini D, Gualdi F, Cammarota G, McGuigan PJ, Thomas M, Skrifvars MB, Niemela VH, Reinikainen M, Bass F, Young PJ, Lilja G, Dankiewicz J, Hammond NE, Hastbacka J, Levin H, Moseby-Knappe M, Saxena M, Tiainen M, Kamp CB, Sillassen CDB, During J, Romundstad LG, Pascal S, Leithner C, Wise MP, Haenggi M, Cole J, Riddell J, Jakobsen JC, Nielsen N, Patroniti NA, Robba C. Ventilation strategies and outcomes after out-of-hospital cardiac arrest: protocol for a pre-planned sub-analysis of the STEPCARE trial. BMJ Open. 2026 Jun 15;16(6):e118872. doi: 10.1136/bmjopen-2026-118872.
PubMed 42297460
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation
- ClinicalTrials.gov ID
- NCT05564754
- Acronym / sponsor ID
- STEPCARE / step2022
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University, Lund, Sweden, Copenhagen Trial Unit, Center for Clinical Intervention Research, The George Institute for Global Health, Australia, HUS Helsinki University Hospitals, Helsinki, Finland, Medical Research Institute of New Zealand Rangahautia Te Ora, Wellington, New Zealand, University Hospital of Wales
- Study start
- 17 Aug 2023 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 3 Oct 2022 (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.
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.
Detailed description
3500 patients who are comatose after cardiac arrest will be included in a trial studying three separate targets. All patients will be randomised to a control or an intervention arm for sedation, temperature and blood pressure targets. These are.
- Continuous deep sedation for 36 hours or minimal sedation (SEDCARE)
- Fever management with or without a feedback-controlled device (TEMPCARE)
- A mean arterial pressure target of >85mmHg or >65mmHg. (MAPCARE)
Participants will be followed up at 30 days and 6 months. The primary outcome will be survival at 6 months.
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 patients taking part in each factor.
| Arm | Type | Receives |
|---|---|---|
| Sedation, temperature device and high MAP | Active comparator | Device: Feedback-controlled temperature device, Other: High MAP, Other: Deep sedationContinuous 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. |
| Sedation, no temperature device and high MAP | Active comparator | Other: High MAP, Other: Deep sedation, Other: Fever control without a deviceContinuous deep sedation for 36 hours. Fever management without a feedback-controlled device. A mean arterial pressure target of >85mmHg. |
| Sedation, temperature device and low MAP | Active comparator | Device: Feedback-controlled temperature device, Other: Deep sedation, Other: Low MAPContinuous 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. |
| Sedation, no temperature device and low MAP | Active comparator | Other: Deep sedation, Other: Fever control without a device, Other: Low MAPContinuous deep sedation for 36 hours. Fever management without a feedback-controlled device. A mean arterial pressure target of >65mmHg. |
| Minimal sedation, temperature device and high MAP | Active comparator | Device: Feedback-controlled temperature device, Other: High MAP, Other: Minimal sedationMinimal 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. |
| Minimal sedation, no temperature device and high MAP | Active comparator | Other: High MAP, Other: Fever control without a device, Other: Minimal sedationMinimal sedation (and early extubation if possible). Fever management without a feedback-controlled device. A mean arterial pressure target of >65mmHg. |
| Minimal sedation, temperature device and low MAP | Active comparator | Device: Feedback-controlled temperature device, Other: Low MAP, Other: Minimal sedationMinimal 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. |
| Minimal sedation, no temperature device and low MAP | Active comparator | Other: Fever control without a device, Other: Low MAP, Other: Minimal sedationMinimal sedation (and early extubation if possible). Fever management without a feedback-controlled device. A mean arterial pressure target of >65mmHg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Out-of-hospital cardiac arrest
- Sustained ROSC - defined as 20 minutes with signs of circulation without the need for chest compressions
- 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.
- Eligible for intensive care without restrictions or limitations
- Inclusion within 4 hours of ROSC
Key exclusion criteria (5 listed)
- On ECMO prior to randomization
- Pregnancy
- Suspected or confirmed intracranial hemorrhage
- Previously randomized in the STEPCARE trial
- Trauma or hemorrhage being the presumed cause of arrest
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 |
|---|---|---|
| Feedback-controlled temperature deviceIf core body temperature exceeds 37.7°C a feedback controlled-device will be used and set at 37.5°C. | Device | Minimal sedation, temperature device and high MAP, Minimal sedation, temperature device and low MAP, Sedation, temperature device and high MAP, Sedation, temperature device and low MAP |
| High MAPA MAP target of >85mmHg will be used. Vasopressors will be titrated to this target during 36h. | 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 36h | 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 ICU 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 MAP target of >65mmHg will be used. Vasopressors will be titrated to this target during 36h. | 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 ICU, 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 high MAP, Minimal sedation, temperature device and low MAP |
Primary outcome
Mortality
Time frame: 6 months
Landmark mortality at follow-up performed at 6 months
2 secondary outcomes
Functional outcome
Time frame: 6 months
Health-related quality of life
Time frame: 6 months
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 2 Jun 2026.
- Derived from this study: PubMed 42297460Battaglini D, Gualdi F, Cammarota G, McGuigan PJ, Thomas M, Skrifvars MB, Niemela VH, Reinikainen M, Bass F, Young PJ, Lilja G, Dankiewicz J, Hammond NE, Hastbacka J, Levin H, Moseby-Knappe M, Saxena M, Tiainen M, Kamp CB, Sillassen CDB, During J, Romundstad LG, Pascal S, Leithner C, Wise MP, Haenggi M, Cole J, Riddell J, Jakobsen JC, Nielsen N, Patroniti NA, Robba C. Ventilation strategies and outcomes after out-of-hospital cardiac arrest: protocol for a pre-planned sub-analysis of the STEPCARE trial. BMJ Open. 2026 Jun 15;16(6):e118872. doi: 10.1136/bmjopen-2026-118872.
- Trial webpageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Upon reasonable request following publication
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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. This study is not recruiting at the moment.
Niklas Nielsen, PhD study chair
Lund University
56 sites in 15 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 56 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. 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: under way, not looking for participants, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in Sweden, Australia, Finland, United Kingdom, New Zealand and 10 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05564754, which also lists 1 linked publication.
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 2 Jun 2026.