Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation

Conditions

Cardiac Arrest With Successful Resuscitation, Hypoxia, Brain

Brief 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.

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. 1. Continuous deep sedation for 36 hours or minimal sedation (SEDCARE) 2. Fever management with or without a feedback-controlled device (TEMPCARE) 3. 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.

Battaglini D, Gualdi F, Cammarota G, McGuigan PJ, Thomas M, Skrifvars MB, Niemelä VH, Reinikainen M, Bass F, Young PJ, Lilja G, Dankiewicz J, Hammond NE, Hästbacka J, Levin H, Moseby-Knappe M, Saxena M, Tiainen M, Kamp CB, Sillassen CDB, Düring J, Romundstad LG, Pascal S, Leithner C, Wise MP, Haenggi M, Cole J, Riddell J, Jakobsen JC, Nielsen N, Patroniti NA, Robba C.

2026-06-15

10.1136/bmjopen-2026-118872

Design of the OverCool study: Lung-conservative liquid ventilation for the induction of Ultra-Rapid Cooling after Cardiac Arrest (OverCool).

Tissier R, Taccone FS, Lamhaut L, Vicaut E, Paublant F, Ricard JD, Mercat A, Cariou A.

2025-03-103 citations

10.1016/j.resplu.2025.100926

Combined effects of targeted blood pressure, oxygenation, and duration of device-based fever prevention after out-of-hospital cardiac arrest on 1-year survival: post hoc analysis of a randomized controlled trial

M Meyer, Christian Hassager, Simon Mølstrøm, Britt Borregaard, Johannes Grand et al. (15 authors)

Critical Care2024-01-1211 citations

10.1186/s13054-023-04794-y

Interventions

DEVICEFeedback-controlled temperature device

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

OTHERHigh MAP

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

OTHERDeep sedation

Deep sedation for at least 36h

OTHERFever control without a device

Management of fever in the ICU without a device

OTHERLow MAP

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

OTHERMinimal sedation

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

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

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.

Intervention model description

2x2x2 factorial, with all patients taking part in each factor.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

1. Out-of-hospital cardiac arrest 2. Sustained ROSC - defined as 20 minutes with signs of circulation without the need for chest compressions 3. 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. 4. Eligible for intensive care without restrictions or limitations 5. Inclusion within 4 hours of ROSC

Exclusion criteria

1. On ECMO prior to randomization 2. Pregnancy 3. Suspected or confirmed intracranial hemorrhage 4. Previously randomized in the STEPCARE trial 5. Trauma or hemorrhage being the presumed cause of arrest

Design outcomes

Primary

Measure	Time frame	Description
Mortality	6 months	Landmark mortality at follow-up performed at 6 months

Secondary

Measure	Time frame	Description
Functional outcome	6 months	Proportion of patients who have a mRS score of 4-6
Health-related quality of life	6 months	EQ5D-5L VAS

Countries

Australia, Belgium, Estonia, Finland, Germany, Ireland, Italy, Luxembourg, New Zealand, Norway, Saudi Arabia, Singapore, Sweden, Switzerland, United Kingdom

Contacts

STUDY_CHAIRNiklas Nielsen, PhD

Lund University

Outcome results

None listed