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Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation
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
Exclusion criteria
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
NA
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
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
| DEVICE: Feedback-controlled temperature device
|
ACTIVE_COMPARATOR: Sedation, no temperature device and high MAP
| OTHER: High MAP
|
ACTIVE_COMPARATOR: Sedation, temperature device and low MAP
| DEVICE: Feedback-controlled temperature device
|
ACTIVE_COMPARATOR: Sedation, no temperature device and low MAP
| OTHER: Deep sedation
|
ACTIVE_COMPARATOR: Minimal sedation, temperature device and high MAP
| DEVICE: Feedback-controlled temperature device
|
ACTIVE_COMPARATOR: Minimal sedation, no temperature device and high MAP
| OTHER: High MAP
|
ACTIVE_COMPARATOR: Minimal sedation, temperature device and low MAP
| DEVICE: Feedback-controlled temperature device
|
ACTIVE_COMPARATOR: Minimal sedation, no temperature device and low MAP
| OTHER: Fever control 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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