Acute Kidney FailureSTEPCARE-MAKENCT07579390
Effects of Sedation, TEmperature and Pressure After Cardiac Arrest and REsuscitation on Major Adverse Kidney Events (STEPCARE-MAKE)
A study testing High MAP, Deep sedation and Low MAP in people with Acute Kidney Failure and Renal Replacement Therapy for Acute Kidney Injury in ICU, run by Helsinki University Central Hospital at 52 sites in 14 countries.
Trial summary
The STEPCARE-MAKE study is a predefined sub-study of the large Sedation, TEmperature and Pressure after Cardiac Arrest and REsuscitation (STEPCARE) trial, which evaluates the effects of three interventions in comatose adult patients resuscitated from out-of-hospital cardiac arrest. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Failure, Renal Replacement Therapy for Acute Kidney Injury in ICU, Sedation in Intensive Care Unit Patients
- 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
- 52 sitesin 14 countries
- Study dates
- 17 Aug 2023to Dec 2026
- 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
- All patients included to the main STEPCARE-trial are also included to this substudy
- Out-of-hospital cardiac arrest
- Sustained return of spontaneous circulation, defined as 20 minutes with signs of circulation without the need for chest compressions
- Unconsciousness (FOUR-score motor response <4, inability to obey verbal commands), or being intubated and sedated due to agitation
- Eligible for intensive care without restrictions or limitations
- Inclusion within 4 hours of the return of spontaneous circulation
Who cannot join
- Out-of-hospital cardiac arrest of presumed traumatic or hemorrhagic origin
- Confirmed or suspected intracranial hemorrhage
- Pregnancy
- Extracorporeal membrane oxygenation (ECMO) prior to randomization
- No additional exclusion criteria are applied beyond those of the main STEPCARE trial
Trial locations and contacts
52 sites in 14 countries.
52 sites in 14 countries
Sweden9 sites
Sahlgrenska University Hospital
Gothenburg
Hallands hospital
Halmstad
Helsingborg Hospital
Helsingborg
Karlstad hospital
Karlstad
Skåne University Hospital
Lund
Skåne University Hospital Malmö
Malmö
Skaraborg Hospital Skovde
Skövde
Karolinska University Hospital
Stockholm
University Hospital of Umeå
Umeå
Australia8 sites
Princess Alexandra Hospital
Brisbane
The Prince Charles Hospital
Brisbane
Nepean Hospital
Kingswood
Liverpool Hospital
Liverpool
Austin Hospital
Melbourne
Royal North Shore Hospital
Sydney
St George Hospital
Sydney
The Sutherland Hospital
Sydney
United Kingdom7 sites
Essex Cardiothoracic Centre
Basildon
Bristol Royal Infirmary
Bristol
Cardiff University Hospital
Cardiff
Leeds General Infirmary
Leeds
Kings College Hospita
London
St Bartholomew's Hospital
London
St Georges University Hospital
London
Finland5 sites
Jorvi Hospital
Espoo
Meilahti Hospital
Helsinki, 00290
Jyväskylä Hospital
Jyväskylä
Kuopio University Hospital
Kuopio
Oulu University Hospital
Oulu
New Zealand5 sites
DCCM ICU
Auckland
Middlemore ICU
Auckland
North Shore ICU NZ
Auckland
Christchurch Hospital
Christchurch
Wellington Hospital
Wellington
Norway4 sites
Soerlandet Hospital Arendal
Arendal
Kalnes Hospital
Grålum
Oslo University Hospital
Oslo
Stavanger University Hospital
Stavanger
Belgium3 sites
HUB Hôpital Erasme
Brussels
Ghent University Hospital
Ghent
Ziekenhuis Oost-Limburg Hospital
Lanaken
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
Official title: Effects of Sedation, TEmperature and Pressure After Cardiac Arrest and REsuscitation on Major Adverse Kidney Events (STEPCARE-MAKE): a Protocol for a Pre-planned Sub-study of a Randomized Clinical Trial
The STEPCARE-MAKE study is a predefined sub-study of the large Sedation, TEmperature and Pressure after Cardiac Arrest and REsuscitation (STEPCARE) trial, which evaluates the effects of three interventions in comatose adult patients resuscitated from out-of-hospital cardiac arrest. In this sub-study, all 3500 participants enrolled in the main trial are assessed for major adverse kidney events (MAKE) and creatinine kinetics.
Read the detailed description
The main STEPCARE trial randomizes patients to three different interventions: (1) continuous deep sedation for 36 hours or minimal sedation (with extubation if feasible), (2) fever control with or without a feedback-controlled device if the temperature rises above 37.7°C, and (3) a mean arterial pressure (MAP) target of ≥65 mmHg or ≥85 mmHg.
This sub-study evaluates the effects of these three interventions on major adverse kidney events (MAKE), defined as a composite of death within 30 days, initiation of renal replacement therapy during the stay in the primary hospital, or persistent renal dysfunction, defined as a final creatinine value ≥200% of baseline at the time of discharge from the primary hospital.
Creatinine kinetics during the stay in the primary hospital and within 72 hours post-resuscitation are evaluated as secondary outcomes.
All data are collected prospectively as part of the main trial protocol, and analyses will be conducted according to a predefined statistical analysis plan.
- Conditions
- Acute Kidney Failure, Renal Replacement Therapy for Acute Kidney Injury in ICU, Sedation in Intensive Care Unit Patients, Sedation in the ICU, Sedation in Intensive Care, Blood Pressure
- Being tested
- Feedback-controlled temperature device, High MAP, Deep sedation, Fever control without a device, Low MAP
- Medical subject headings
- Acute Kidney Injury, Fever, Out-of-Hospital Cardiac Arrest, Heart Arrest
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, sedation 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 rises above 37.7°C and 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 and 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 rises above 37.7°C and 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 and 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 rises above 37.7°C and 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 and 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 rises above 37.7°C and 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 and 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.
Major adverse kidney event (MAKE)
A composite endpoint of MAKE: death from any cause by day 30, initiation of RRT during the stay in the primary hospital or persistent renal dysfunction defined as final creatinine value ≥200 % of the baseline (the highest outpatient creatinine in the previous six months, or if unavailable, the creatinine on admission) at the time of discharge from the primary hospital
Measured: 30 days
Secondary outcomes (4)
Difference between baseline and the highest in-hospital creatinine
Difference between baseline (the highest outpatient creatinine in the previous six months, or if unavailable, the creatinine on admission) and the highest in-hospital creatinine
Measured: During the stay in the index hospital following cardiac arrest, until discharge or transfer to another hospital, and within 30 days
Difference between baseline and the last measured in-hospital creatinine
Difference between baseline (the highest outpatient creatinine in the previous six months, or if unavailable, the creatinine on admission) and the last measured in-hospital creatinine (in the primary hospital)
Measured: At the time of discharge or transfer to another hospital from the index hospital following cardiac arrest, and within 30 days
Difference between baseline and 72-hour creatinine
Difference between baseline (the highest outpatient creatinine in the previous six months, or if unavailable, the creatinine on admission) and 72-hour creatinine
Measured: 72 hours
Difference between baseline and the highest creatinine within 72 hours
Difference between baseline (the highest outpatient creatinine in the previous six months, or if unavailable, the creatinine on admission) and the highest creatinine within 72 hours
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start17 Aug 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney FailureStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miikka Keski-Keturi, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579390
- Sponsor's protocol ID
- STEPCARE-MAKE
- Acronym
- STEPCARE-MAKE
- Status last verified
- May 2026
- First submitted
- 28 Apr 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- Effects of Sedation, TEmperature and Pressure After Cardiac Arrest and REsuscitation on Major Adverse Kidney Events (STEPCARE-MAKE): a Protocol for a Pre-planned Sub-study of a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07579390
- Acronym / sponsor ID
- STEPCARE-MAKE / STEPCARE-MAKE
- Conditions
- Acute Kidney Failure, Renal Replacement Therapy for Acute Kidney Injury in ICU, Sedation in Intensive Care Unit Patients, Sedation in the ICU, Sedation in Intensive Care, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 17 Aug 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 May 2026 (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-MAKE study is a predefined sub-study of the large Sedation, TEmperature and Pressure after Cardiac Arrest and REsuscitation (STEPCARE) trial, which evaluates the effects of three interventions in comatose adult patients resuscitated from out-of-hospital cardiac arrest. In this sub-study, all 3500 participants enrolled in the main trial are assessed for major adverse kidney events (MAKE) and creatinine kinetics.
Detailed description
The main STEPCARE trial randomizes patients to three different interventions: (1) continuous deep sedation for 36 hours or minimal sedation (with extubation if feasible), (2) fever control with or without a feedback-controlled device if the temperature rises above 37.7°C, and (3) a mean arterial pressure (MAP) target of ≥65 mmHg or ≥85 mmHg.
This sub-study evaluates the effects of these three interventions on major adverse kidney events (MAKE), defined as a composite of death within 30 days, initiation of renal replacement therapy during the stay in the primary hospital, or persistent renal dysfunction, defined as a final creatinine value ≥200% of baseline at the time of discharge from the primary hospital.
Creatinine kinetics during the stay in the primary hospital and within 72 hours post-resuscitation are evaluated as secondary outcomes.
All data are collected prospectively as part of the main trial protocol, and analyses will be conducted according to a predefined statistical analysis plan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 8
| 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 rises above 37.7°C and 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 and 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 rises above 37.7°C and 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 and 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 rises above 37.7°C and 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 and 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 rises above 37.7°C and 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 and 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 (6 listed)
- All patients included to the main STEPCARE-trial are also included to this substudy
- Out-of-hospital cardiac arrest
- Sustained return of spontaneous circulation, defined as 20 minutes with signs of circulation without the need for chest compressions
- Unconsciousness (FOUR-score motor response <4, inability to obey verbal commands), or being intubated and sedated due to agitation
- Eligible for intensive care without restrictions or limitations
Key exclusion criteria (5 listed)
- Out-of-hospital cardiac arrest of presumed traumatic or hemorrhagic origin
- Confirmed or suspected intracranial hemorrhage
- Pregnancy
- Extracorporeal membrane oxygenation (ECMO) prior to randomization
- No additional exclusion criteria are applied beyond those of the main STEPCARE trial
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, sedation 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
Major adverse kidney event (MAKE)
Time frame: 30 days
A composite endpoint of MAKE: death from any cause by day 30, initiation of RRT during the stay in the primary hospital or persistent renal dysfunction defined as final creatinine value ≥200 % of the baseline (the highest outpatient creatinine in the previous six months, or if unavailable, the creatinine on admission) at the time of discharge from the primary hospital
4 secondary outcomes
Difference between baseline and the highest in-hospital creatinine
Time frame: During the stay in the index hospital following cardiac arrest, until discharge or transfer to another hospital, and within 30 days
Difference between baseline and the last measured in-hospital creatinine
Time frame: At the time of discharge or transfer to another hospital from the index hospital following cardiac arrest, and within 30 days
Difference between baseline and 72-hour creatinine
Time frame: 72 hours
Difference between baseline and the highest creatinine within 72 hours
Time frame: 72 hours
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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
52 sites in 14 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 Acute Kidney Failure and Renal Replacement Therapy for Acute Kidney Injury in ICU, run by Helsinki University Central Hospital at 52 sites in 14 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 6 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 52 sites in Sweden, Australia, United Kingdom, Finland, New Zealand and 9 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?
Major adverse kidney event (MAKE) (time frame: 30 days). 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 2 Jun 2026.