Effects of Sedation, TEmperature and Pressure After Cardiac Arrest and REsuscitation on Major Adverse Kidney Events (STEPCARE-MAKE)

NCT07579390 | Recruiting DMC

• 1 other identifier: STEPCARE-MAKE
• Study Type: interventional
• Target: 3,500
• Locations: 14 countries
• Sites: 52

Brief 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. In this sub-study, all 3500 participants enrolled in the main trial are assessed for major adverse kidney events (MAKE) and creatinine kinetics.

Conditions

Renal Replacement Therapy for Acute Kidney Injury in ICU; Acute Kidney Failure; Sedation in Intensive Care Unit Patients; Sedation in the ICU; Sedation in Intensive Care; Blood Pressure; Mean Arterial Pressure Targets; Temperature; Fever; Resuscitated Sudden Cardiac Death; Out of Hospital Cardiac Arrest; Cardiac Arrest (CA)

Outcome Measures

Primary Outcomes (1)

• 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

  30 days

Secondary Outcomes (4)

• Difference between baseline and the highest in-hospital creatinine

  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

  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

  72 hours

• Difference between baseline and the highest creatinine within 72 hours

  72 hours

Study Arms (8)

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

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

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

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

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

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

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

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

Other: Fever control without a device; Other: Low MAP; Other: Minimal sedation

Interventions

Feedback-controlled temperature device DEVICE

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

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 MAP OTHER

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

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

Fever control without a device OTHER

Management of fever in the ICU without a device

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 MAP OTHER

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

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 sedation OTHER

A strategy of minimal sedation in the ICU, sedation used only as needed to facilitate transport, imaging and invasive procedures

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

Deep sedation OTHER

Deep sedation for at least 36h

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Out-of-hospital cardiac arrest of presumed traumatic or hemorrhagic origin
• Confirmed or suspected intracranial hemorrhage
• Pregnancy
• Extracorporeal membrane oxygenation (ECMO) prior to randomization

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (52)

Princess Alexandra Hospital

Brisbane, Australia

RECRUITING

The Prince Charles Hospital

Brisbane, Australia

RECRUITING

Nepean Hospital

Kingswood, Australia

RECRUITING

Liverpool Hospital

Liverpool, Australia

RECRUITING

Austin Hospital

Melbourne, Australia

RECRUITING

Royal North Shore Hospital

Sydney, Australia

RECRUITING

St George Hospital

Sydney, Australia

RECRUITING

The Sutherland Hospital

Sydney, Australia

RECRUITING

HUB Hôpital Erasme

Brussels, Belgium

RECRUITING

Ghent University Hospital

Ghent, Belgium

RECRUITING

Ziekenhuis Oost-Limburg Hospital

Lanaken, Belgium

RECRUITING

North Estonia Medical Centre

Tallinn, Estonia

RECRUITING

Jorvi Hospital

Espoo, Finland

RECRUITING

Meilahti Hospital

Helsinki, 00290, Finland

RECRUITING

Jyväskylä Hospital

Jyväskylä, Finland

RECRUITING

Kuopio University Hospital

Kuopio, Finland

RECRUITING

Oulu University Hospital

Oulu, Finland

RECRUITING

Charite University Hospital

Berlin, Germany

RECRUITING

Lübeck University Hospital

Lübeck, Germany

RECRUITING

Tubingen University Hospital

Tübingen, Germany

RECRUITING

San Martino Hospital Genova

Genova, Italy

RECRUITING

Centre Hospitalier de Luxembourg

Luxembourg, Luxembourg

RECRUITING

DCCM ICU

Auckland, New Zealand

RECRUITING

Middlemore ICU

Auckland, New Zealand

RECRUITING

North Shore ICU NZ

Auckland, New Zealand

RECRUITING

Christchurch Hospital

Christchurch, New Zealand

RECRUITING

Wellington Hospital

Wellington, New Zealand

RECRUITING

Soerlandet Hospital Arendal

Arendal, Norway

RECRUITING

Kalnes Hospital

Grålum, Norway

RECRUITING

Oslo University Hospital

Oslo, Norway

RECRUITING

Stavanger University Hospital

Stavanger, Norway

RECRUITING

King Abdulaziz Medical City

Riyadh, Saudi Arabia

RECRUITING

Tan Tock Seng Hospital

Singapore, Singapore

RECRUITING

Sahlgrenska University Hospital

Gothenburg, Sweden

RECRUITING

Hallands hospital

Halmstad, Sweden

RECRUITING

Helsingborg Hospital

Helsingborg, Sweden

RECRUITING

Karlstad hospital

Karlstad, Sweden

RECRUITING

Skåne University Hospital

Lund, Sweden

RECRUITING

Skåne University Hospital Malmö

Malmö, Sweden

RECRUITING

Skaraborg Hospital Skovde

Skövde, Sweden

RECRUITING

Karolinska University Hospital

Stockholm, Sweden

RECRUITING

University Hospital of Umeå

Umeå, Sweden

RECRUITING

Bern University Hospital

Bern, Switzerland

RECRUITING

St Gallen Hospital

Sankt Gallen, Switzerland

RECRUITING

University Hospital Zürich

Zurich, Switzerland

RECRUITING

Essex Cardiothoracic Centre

Basildon, United Kingdom

RECRUITING

Bristol Royal Infirmary

Bristol, United Kingdom

RECRUITING

Cardiff University Hospital

Cardiff, United Kingdom

RECRUITING

Leeds General Infirmary

Leeds, United Kingdom

RECRUITING

Kings College Hospita

London, United Kingdom

RECRUITING

St Bartholomew's Hospital

London, United Kingdom

RECRUITING

St Georges University Hospital

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury; Fever; Out-of-Hospital Cardiac Arrest; Heart Arrest

Interventions

Deep Sedation

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Central Study Contacts

Markus B Skrifvars, Prof

CONTACT

+358 50 427 2424; markus.skrifvars@hus.fi

Miikka Keski-Keturi, MD

CONTACT

miikka.keski-keturi@hus.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded. Assessors of neurological prognosis will be blinded. Outcome assessors and investigators will be blinded. Health-care personnel will not be blinded.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 12, 2026
• Study Start: August 17, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 14, 2026

Record last verified: 2026-05

Locations

SE (9); BE (3); AU (8); LU (1); SA (1); ES (1); FI (5); IT (1); NO (4); SG (1); GB (7); NZ (5); DE (3); CH (3)