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Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation

RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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

Exclusion criteria

On ECMO prior to randomization

Pregnancy

Suspected or confirmed intracranial hemorrhage

Previously randomized in the STEPCARE trial.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-08-17

Primary completion: 2025-12-01

Study completion finish: 2026-06-01

Study type

TREATMENT

Phase

Trial ID

NCT05564754

Intervention or treatment

DEVICE: Feedback-controlled temperature device

OTHER: High MAP

OTHER: Deep sedation

OTHER: Fever control without a device

OTHER: Low MAP

OTHER: Minimal sedation

Conditions

• Cardiac Arrest With Successful Resuscitation
• Hypoxia, Brain

Image related to Cardiac Arrest With Successful Resuscitation

Condition: Cardiac Arrest With Successful Resuscitation, Hypoxia, Brain
DEVICE: Feedback-controlled temperature device and other drugs
Newcastle, New South Wales, Australia and more
Sponsor: Region Skane

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

John Hunter Hospital

Research sites nearby

Select from list below to view details:

John Hunter Hospital
Newcastle, New South Wales, Australia
Royal North Shore Hospital
Sydney, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: Sedation, temperature device and high MAP 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.	DEVICE: Feedback-controlled temperature device If core body temperature exceeds 37.7°C a feedback controlled-device will be used and set at 37.5°C.
ACTIVE_COMPARATOR: Sedation, no temperature device and high MAP Continuous deep sedation for 36 hours. Fever management without a feedback-controlled device. A mean arterial pressure target of \>85mmHg.	OTHER: High MAP A MAP target of \>85mmHg will be used. Vasopressors will be titrated to this target during 36h.
ACTIVE_COMPARATOR: Sedation, temperature device and low MAP 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.	DEVICE: Feedback-controlled temperature device If core body temperature exceeds 37.7°C a feedback controlled-device will be used and set at 37.5°C.
ACTIVE_COMPARATOR: Sedation, no temperature device and low MAP Continuous deep sedation for 36 hours. Fever management without a feedback-controlled device. A mean arterial pressure target of \>65mmHg.	OTHER: Deep sedation Deep sedation for at least 36h
ACTIVE_COMPARATOR: Minimal sedation, temperature device and high MAP 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.	DEVICE: Feedback-controlled temperature device If core body temperature exceeds 37.7°C a feedback controlled-device will be used and set at 37.5°C.
ACTIVE_COMPARATOR: Minimal sedation, no temperature device and high MAP Minimal sedation (and early extubation if possible). Fever management without a feedback-controlled device. A mean arterial pressure target of \>65mmHg.	OTHER: High MAP A MAP target of \>85mmHg will be used. Vasopressors will be titrated to this target during 36h.
ACTIVE_COMPARATOR: Minimal sedation, temperature device and low MAP 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.	DEVICE: Feedback-controlled temperature device If core body temperature exceeds 37.7°C a feedback controlled-device will be used and set at 37.5°C.
ACTIVE_COMPARATOR: Minimal sedation, no temperature device and low MAP Minimal sedation (and early extubation if possible). Fever management without a feedback-controlled device. A mean arterial pressure target of \>65mmHg.	OTHER: Fever control without a device Management of fever in the ICU without a device

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Mortality	Landmark mortality at follow-up performed at 6 months	6 months

Secondary outcome

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

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

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References

Clinical Trials Gov: Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation