Overview Study details Eligibility Things to know Research Study plan

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Overview Study details Eligibility Things to know Research Study plan

Simplify with AI

Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation

NAACTIVE_NOT_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.

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.

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
Trauma or hemorrhage being the presumed cause of arrest

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

Study type

TREATMENT

Phase

Study 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

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

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Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

Nepean Hospital

Select from list below to view details:

Nepean Hospital
Kingswood, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Royal North Shore Hospital
Sydney, New South Wales, Australia
St George Hospital
Sydney, New South Wales, Australia

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Who is running the clinical trial?

Region Skane

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, Other: High MAP, Other: Deep sedation
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, Other: Deep sedation, Other: Fever control without a device
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, Other: Deep sedation, Other: Low MAP
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, Other: Fever control without a device, Other: Low MAP
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, Other: High MAP, Other: Minimal sedation
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, Other: Fever control without a device, Other: Minimal sedation
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, Other: Low MAP, Other: Minimal sedation
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, Other: Low MAP, Other: Minimal sedation

What is the study measuring?

Primary Outcome

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

Secondary Outcome

Measure	Description	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

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

Claim this trial

References

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

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