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Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation (STEPCARE)

Primary Purpose

Cardiac Arrest With Successful Resuscitation, Hypoxia, Brain

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Feedback-controlled temperature device
High MAP
Deep sedation
Fever control without a device
Low MAP
Minimal sedation
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest With Successful Resuscitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. Unwitnessed cardiac arrest with an initial rhythm of asystole
  2. On ECMO prior to randomization
  3. Pregnancy
  4. Suspected or confirmed intracranial hemorrhage
  5. Previously randomized in the STEPCARE trial.

Sites / Locations

  • Nepean Hospital
  • Liverpool Hospital
  • John Hunter Hospital
  • Concord Repatriation Hospital
  • Royal North Shore Hospital
  • St George Hospital
  • The Sutherland Hospital
  • Westmead Hospital
  • Princess Alexandra Hospital
  • The Prince Charles Hospital
  • Northern Hospital
  • Austin Hospital
  • The Victorian Heart Hospital
  • Helsinki Helsingforgs University Central HospitalRecruiting
  • Kuopio University Hospital
  • Centre Hospitalier de Luxembourg
  • Wellington HospitalRecruiting
  • Hallands hospitalRecruiting
  • Helsingborg Hospital
  • Skåne University HospitalRecruiting
  • Skåne University Hospital MalmöRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Sedation, temperature device and high MAP

Sedation, no temperature device and high MAP

Sedation, temperature device and low MAP

Sedation, no temperature device and low MAP

Minimal sedation, temperature device and high MAP

Minimal sedation, no temperature device and high MAP

Minimal sedation, temperature device and low MAP

Minimal sedation, no temperature device and low MAP

Arm Description

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.

Continuous deep sedation for 36 hours. Fever management without a feedback-controlled device. A mean arterial pressure target of >85mmHg.

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.

Continuous deep sedation for 36 hours. Fever management without a feedback-controlled device. A mean arterial pressure target of >65mmHg.

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.

Minimal sedation (and early extubation if possible). Fever management without a feedback-controlled device. A mean arterial pressure target of >65mmHg.

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.

Minimal sedation (and early extubation if possible). Fever management without a feedback-controlled device. A mean arterial pressure target of >65mmHg.

Outcomes

Primary Outcome Measures

Mortality
Landmark mortality at follow-up performed at 6 months

Secondary Outcome Measures

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

Full Information

First Posted
September 29, 2022
Last Updated
October 16, 2023
Sponsor
Region Skane
Collaborators
Lund University, Lund, Sweden, Copenhagen Trial Unit, Center for Clinical Intervention Research, The George Institute for Global Health, Australia, HUS Helsinki University Hospitals, Helsinki, Finland, Medical Research Institute of New Zealand Rangahautia Te Ora, Wellington, New Zealand
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1. Study Identification

Unique Protocol Identification Number
NCT05564754
Brief Title
Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation
Acronym
STEPCARE
Official Title
Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 17, 2023 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Skane
Collaborators
Lund University, Lund, Sweden, Copenhagen Trial Unit, Center for Clinical Intervention Research, The George Institute for Global Health, Australia, HUS Helsinki University Hospitals, Helsinki, Finland, Medical Research Institute of New Zealand Rangahautia Te Ora, Wellington, New Zealand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest With Successful Resuscitation, Hypoxia, Brain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
2x2x2 factorial, with all patients taking part in each factor.
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
3500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sedation, temperature device and high MAP
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sedation, no temperature device and high MAP
Arm Type
Active Comparator
Arm Description
Continuous deep sedation for 36 hours. Fever management without a feedback-controlled device. A mean arterial pressure target of >85mmHg.
Arm Title
Sedation, temperature device and low MAP
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sedation, no temperature device and low MAP
Arm Type
Active Comparator
Arm Description
Continuous deep sedation for 36 hours. Fever management without a feedback-controlled device. A mean arterial pressure target of >65mmHg.
Arm Title
Minimal sedation, temperature device and high MAP
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Minimal sedation, no temperature device and high MAP
Arm Type
Active Comparator
Arm Description
Minimal sedation (and early extubation if possible). Fever management without a feedback-controlled device. A mean arterial pressure target of >65mmHg.
Arm Title
Minimal sedation, temperature device and low MAP
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Minimal sedation, no temperature device and low MAP
Arm Type
Active Comparator
Arm Description
Minimal sedation (and early extubation if possible). Fever management without a feedback-controlled device. A mean arterial pressure target of >65mmHg.
Intervention Type
Device
Intervention Name(s)
Feedback-controlled temperature device
Intervention Description
If core body temperature exceeds 37.7°C a feedback controlled-device will be used and set at 37.5°C.
Intervention Type
Other
Intervention Name(s)
High MAP
Intervention Description
A MAP target of >85mmHg will be used. Vasopressors will be titrated to this target during 36h.
Intervention Type
Other
Intervention Name(s)
Deep sedation
Intervention Description
Deep sedation for at least 36h
Intervention Type
Other
Intervention Name(s)
Fever control without a device
Intervention Description
Management of fever in the ICU without a device
Intervention Type
Other
Intervention Name(s)
Low MAP
Intervention Description
A MAP target of >65mmHg will be used. Vasopressors will be titrated to this target during 36h.
Intervention Type
Other
Intervention Name(s)
Minimal sedation
Intervention Description
A strategy of minimal sedation in the ICU, used only as needed to facilitate transport, imaging and invasive procedures.
Primary Outcome Measure Information:
Title
Mortality
Description
Landmark mortality at follow-up performed at 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Functional outcome
Description
Proportion of patients who have a mRS score of 4-6
Time Frame
6 months
Title
Health-related quality of life
Description
EQ5D-5L VAS
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
ICU stay
Description
Length of stay for ICU survivors
Time Frame
6 months
Title
Days at home within the first 30 days
Description
Days outside of hospital within the first 30 days
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Josef Dankiewicz, PhD
Phone
+464671000
Email
josef.dankiewicz@med.lu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Niklas Nielsen, PhD
Phone
+46424061000
Email
niklas.nielsen@med.lu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niklas Nielsen, PhD
Organizational Affiliation
Lund University
Official's Role
Study Chair
Facility Information:
Facility Name
Nepean Hospital
City
Kingswood
State/Province
New South Wales
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ian Seppelt, Dr
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antony Stewart, Dr.
Facility Name
John Hunter Hospital
City
Newcastle
State/Province
New South Wales
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ed Martinez, Dr
Facility Name
Concord Repatriation Hospital
City
Sydney
State/Province
New South Wales
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Winston Cheung, A/Prof
Facility Name
Royal North Shore Hospital
City
Sydney
State/Province
New South Wales
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wade Stedman, Dr
Facility Name
St George Hospital
City
Sydney
State/Province
New South Wales
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manoj Saxena, Dr
Facility Name
The Sutherland Hospital
City
Sydney
State/Province
New South Wales
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anas Naeem, Dr
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Bowen, Dr
Facility Name
Princess Alexandra Hospital
City
Brisbane
State/Province
Queensland
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Walsham, Dr
Facility Name
The Prince Charles Hospital
City
Brisbane
State/Province
Queensland
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denzil Gill, Dr
Facility Name
Northern Hospital
City
Epping
State/Province
Victoria
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angaj Ghosh, Dr
Facility Name
Austin Hospital
City
Melbourne
State/Province
Victoria
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rinaldo Bellomo, Prof
Facility Name
The Victorian Heart Hospital
City
Melbourne
State/Province
Victoria
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Bernard, Prof
Facility Name
Helsinki Helsingforgs University Central Hospital
City
Helsinki
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Markus Skrifvars, PhD
First Name & Middle Initial & Last Name & Degree
Markus Skrifvars, PhD
First Name & Middle Initial & Last Name & Degree
Johanna Hästbacka, PhD
First Name & Middle Initial & Last Name & Degree
Marjaana Tiainen, PhD
Facility Name
Kuopio University Hospital
City
Kuopio
Country
Finland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matti Reinikainen, PhD
First Name & Middle Initial & Last Name & Degree
Matti Reinikainen, PhD
Facility Name
Centre Hospitalier de Luxembourg
City
Luxembourg
Country
Luxembourg
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal Stammet, MD, PdH
First Name & Middle Initial & Last Name & Degree
Pascal Stammet, MD, PhD
Facility Name
Wellington Hospital
City
Wellington
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Young
Facility Name
Hallands hospital
City
Halmstad
State/Province
Halland
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johan Undén, MD, PhD
First Name & Middle Initial & Last Name & Degree
Johan Undén, MD, PhD
Facility Name
Helsingborg Hospital
City
Helsingborg
State/Province
Skåne
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesper Johnsson, MD,PhD
First Name & Middle Initial & Last Name & Degree
Jesper Johnsson, MD,PhD
Facility Name
Skåne University Hospital
City
Lund
State/Province
Skåne
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Lybeck, MD,PhD
First Name & Middle Initial & Last Name & Degree
Anna Lybeck, MD,PhD
Facility Name
Skåne University Hospital Malmö
City
Malmö
State/Province
Skåne
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joachim Düring, MD,PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Upon reasonable request following publication

Learn more about this trial

Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation

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