Stepcare Extended Follow-up Substudy

Extended Follow-up Substudy of the Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation -STEPCARE Trial

To provide detailed information on long-term outcomes in relation to potential neuroprotection and improvements in recovery for different targets of sedation, temperature, and pressure management in post out of hospital cardiac arrest survivors at 6 and 12 months. In addition, the impact of caring for a post OHCA survivor will be explored.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Impairment; Caregiver Burden; Hypoxia, Brain; Cardiac Arrest With Successful Resuscitation
• Intervention / Treatment: Device: Feed back controlled temperature device; Other: High MAP; Other: Deep sedation; Other: Fever control without a device; Other: Low MAP; Other: Minimal sedation

Detailed Description

This extended follow-up substudy is incorporated into the multi-center, international, factorial randomized Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation -STEPCARE trial (Clinical trials identifier:NCT05564754) were out of hospital cardiac arrest participants will be randomized to different targets of sedation, temperature, and MAP management.

Only selected STEPCARE sites will participate in this extended follow-up substudy. At the extended follow up participating sites all out of hospital cardiac arrest participants randomized in the STEPCARE trial, who survive and provide consent, will be eligible to participate in this substudy, with no further inclusion or exclusion criteria.The extended follow-up substudy is estimated to enroll approximately 600 post OHCA survivors. One nominated caregiver per post OHCA survivor will be invited to be included in the study.

Participants will be followed up at 6 and 12 months.

The primary outcome for this extended follow up substudy is cognitive function at 6 months for the out of hospital cardiac arrest survivors andCaregiver burden at 6 months for the caregivers.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gisela Lilja, PhD; Phone Number: +4646176393; Email: gisela.lilja@med.lu.se

Study Locations

• Australia
  • Brisbane, Australia
    • Recruiting
    • Princess Alexandra Hospital
    • Contact: James Walsham
  • Caringbah, Australia
    • Recruiting
    • The Sutherland Hospital
    • Contact: Frances Bass
  • Chermside, Australia
    • Recruiting
    • The Prince Charles Hospital
    • Contact: Frances Bass
  • Kingswood, Australia
    • Recruiting
    • Nepean Hospital
    • Contact: Ian Seppelt, Dr
  • Kogarah, Australia
    • Recruiting
    • St George Hospital
  • Liverpool, Australia
    • Recruiting
    • Liverpool Hospital
    • Contact: Anthony Stewart, Dr
  • Melbourne, Australia
    • Recruiting
    • Austin Hospital
  • Sydney, Australia
    • Recruiting
    • Royal North Shore Hospital
    • Contact: Frances Bass
• Belgium
  • Genk, Belgium
    • Recruiting
    • Ziekenhuis Oost Limburg
  • Ghent, Belgium
    • Recruiting
    • Ghent University Hospital
    • Contact: Patrick Druwve
• Finland
  • Helsinki, Finland
    • Recruiting
    • Helsinki Helsingfors university central hospital
    • Contact: Marjaana Tiainen
  • Jorvi, Finland
    • Recruiting
    • Jorvi Hospital
  • Tampere, Finland
    • Recruiting
    • Tampere University Hospital
    • Contact: Joonas Tirkkonen
• Germany
  • Berlin, Germany
    • Recruiting
    • Charite University Hospital
    • Contact: Christoph Leithner
  • Lübeck, Germany
    • Recruiting
    • Universitäres Herzzentrum Lübeck Universitätsklinikum Schleswig-Holstein
    • Contact: Tobias Graf
  • Tubingen, Germany
    • Recruiting
    • Tubingen University Hospital
• Luxembourg
  • Luxembourg, Luxembourg
    • Recruiting
    • Centre Hospitalier de Luxembourg
    • Contact: Pascal Stammet, MD, PhD
• New Zealand
  • Auckland, New Zealand
    • Recruiting
    • Auckland City Hospital
  • Auckland, New Zealand
    • Recruiting
    • Middlemore Hospital
    • Contact: Paul Young
  • Christchurch, New Zealand
    • Recruiting
    • Christchurch Hospital
    • Contact: Paul Young
  • Wellington, New Zealand
    • Recruiting
    • Wellington Hospital
    • Contact: Paul Young
• Norway
  • Arendal, Norway
    • Recruiting
    • Sorlandet hospital
  • Oslo, Norway
    • Recruiting
    • Oslo University Hospital Rikshospitalet
    • Contact: Louis Romundstad
• Sweden
  • Gothenburg, Sweden
    • Recruiting
    • Sahlgrenska University Hospital
    • Contact: Andreas Lundin
    • Contact: Jonathan Oras
  • Halland, Sweden
    • Recruiting
    • Hallands hospital
    • Contact: Johan Unden, MD PhD
  • Helsingborg, Sweden
    • Recruiting
    • Helsingborg Hospital
    • Contact: Jesper Johnsson, MD, PhD
  • Lund, Sweden
    • Recruiting
    • Skane University Hospital
    • Contact: Anna Lybeck, MD, PhD
  • Malmö, Sweden
    • Recruiting
    • Skane University Hopsital
    • Contact: Joachim During, MD, PhD
• Switzerland
  • Bern, Switzerland
    • Recruiting
    • Bern University Hospital
    • Contact: Manuela Itens
  • Saint Gallen, Switzerland
    • Recruiting
    • Kantonsspital St. Gallen
    • Contact: Claudia Schrag
• United Kingdom
  • Basildon, United Kingdom
    • Recruiting
    • The Essex Cardiothoracic Centre
    • Contact: Thomas Keeble
  • Bristol, United Kingdom
    • Recruiting
    • Bristol Royal Infirmary
    • Contact: Matthew Thomas
  • Cardiff, United Kingdom
    • Recruiting
    • University Hospital of Wales
    • Contact: Matt Wise
  • London, United Kingdom
    • Recruiting
    • St Bartholomew's Hospital
    • Contact: Nikolaos Gorgoraptis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

All OHCA participants randomized in the STEPCARE trial at the extended follow-up participating sites, who survive and provide consent, with no further inclusion or exclusion criteria.

The inclusion and exclusion criteria for the STEPCARE trial are:

• Inclusion criteria: out-of-hospital cardiac arrest of non-traumatic origin, minimum of 20 minutes without chest compressions (defined as stable return of spontaneous circulation. ROSC), unconsciousness (defined as not being able to obey verbal commands equal to a FOUR-score motor response of <4, or being intubated and sedated because of agitation after sustained ROSC, eligible for intensive care without restrictions or limitation, inclusion within 4 hours (240 minutes) of ROSC (or 220 minutes of stable ROSC).
• Exclusion criteria: on ECMO prior to randomization, pregnancy, suspected or confirmed intracranial hemorrhage, previously randomized in the STEPCARE trial.

For caregivers, the eligibility will be that they live with, or have weekly or more frequent contact (in person or over the telephone) with the post OHCA survivor. Only one nominated caregiver per post OHCA survivor will be able to be included in the study. This would typically be the caregiver that would identify as the primary caregiver of the post OHCA survivor if needed, but may also be another close family member.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sedation, temperature device and high MAP	Device: Feed back controlled temperature device; If core temperature exceeds 37.7 degrees celsius a feedback controlled-device will be used at set to 37.5 degrees celsius; Other: High MAP; A mean arterial blood pressure (MAP) of >85mmHg will be used. Vasopressors will be titrated to this target during 36 hours; Other: Deep sedation; Deep sedation for at least 36 hours
Active Comparator: Sedation, no temperature device and high MAP	Other: High MAP; A mean arterial blood pressure (MAP) of >85mmHg will be used. Vasopressors will be titrated to this target during 36 hours; Other: Deep sedation; Deep sedation for at least 36 hours; Other: Fever control without a device; Management of fever in the intensive care unit without a device
Active Comparator: Sedation, temperature device and low MAP	Device: Feed back controlled temperature device; If core temperature exceeds 37.7 degrees celsius a feedback controlled-device will be used at set to 37.5 degrees celsius; Other: Deep sedation; Deep sedation for at least 36 hours; Other: Low MAP; A mean arterial blood pressure (MAP) of >65mmHG will be used. Vasopressors will be titrated to this target during 36 hours
Active Comparator: Sedation, no temperature device, and low MAP	Other: Deep sedation; Deep sedation for at least 36 hours; Other: Fever control without a device; Management of fever in the intensive care unit without a device; Other: Low MAP; A mean arterial blood pressure (MAP) of >65mmHG will be used. Vasopressors will be titrated to this target during 36 hours
Active Comparator: Minimal sedation, temperature device, and high MAP	Device: Feed back controlled temperature device; If core temperature exceeds 37.7 degrees celsius a feedback controlled-device will be used at set to 37.5 degrees celsius; Other: High MAP; A mean arterial blood pressure (MAP) of >85mmHg will be used. Vasopressors will be titrated to this target during 36 hours; Other: Minimal sedation; A strategy of minimal sedation in the intensive care unit, used only as needed to facilitate transport, imaging and invasive procedures
Active Comparator: Minimal sedation, no temperature device and high MAP	Other: High MAP; A mean arterial blood pressure (MAP) of >85mmHg will be used. Vasopressors will be titrated to this target during 36 hours; Other: Fever control without a device; Management of fever in the intensive care unit without a device; Other: Minimal sedation; A strategy of minimal sedation in the intensive care unit, used only as needed to facilitate transport, imaging and invasive procedures
Active Comparator: Minimal sedation, temperature device and low MAP	Device: Feed back controlled temperature device; If core temperature exceeds 37.7 degrees celsius a feedback controlled-device will be used at set to 37.5 degrees celsius; Other: Low MAP; A mean arterial blood pressure (MAP) of >65mmHG will be used. Vasopressors will be titrated to this target during 36 hours; Other: Minimal sedation; A strategy of minimal sedation in the intensive care unit, used only as needed to facilitate transport, imaging and invasive procedures
Active Comparator: Minimal sedation, no temperature device and low MAP	Other: Fever control without a device; Management of fever in the intensive care unit without a device; Other: Low MAP; A mean arterial blood pressure (MAP) of >65mmHG will be used. Vasopressors will be titrated to this target during 36 hours; Other: Minimal sedation; A strategy of minimal sedation in the intensive care unit, used only as needed to facilitate transport, imaging and invasive procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montreal Cognitive Assessment (MoCA)	Cognitive function for out of hospital cardiac arrest survivors. Score range. Higher scores=better cognition	6 months
Zarit Burden Interview (ZBI)	Caregiver burden for caregivers to out of hospital cardiac arrest survivors. Score range 0-88. Higher scores= worse indicating more caregiver burden	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symbol Digit Modalities Test (SDMT)	Processing speed. For out of hospital cardiac arrest survivors. Scores presented as age and education adjusted z-scores. Higher scores=better	6 and 12 months
Hospital Anxiety and Depression Scale (HADS)	Symptoms of anxiety and depression. For both out of hospital cardiac arrest survivors and caregivers. Score range 0-21 for anxiety and depression respectively. Higher scores=worse and incerased symptoms of anxiety and depression	6 and 12 months
Post Posttraumatic Stress Disorders Checklist updated for DSM-5 (PCL-5)	Symptoms of posttraumatic stress. For both out of hospital cardiac arrest survivors and caregivers. Score range 0-80. Higher scores=worse indicating increased symptoms of PTSD	6 and 12 months
Modified Fatigue Impact Scale (MFIS)	Impact of fatigue. For out of hospital cardiac arrest survivors. Score range 0-84. Higher scores= worse indicating more problems with impact of fatigue	6 and 12 months
modified Rankin Scale (mRS)	Functional outcome. For out of hospital cardiac arrest survivors. Score range 0-6. Higher scores= worse indicating a poorer functional outcome	12 months
World Health Organization Disability Assessment (WHODAS) 2.0	Disability. For both out of hospital cardiac arrest survivors and caregivers. 36 item version score range 0-100. 12 item version score range 0-48. Higher scores=worse indicating more disability	6 and 12 months
Return to work	Questions about work prior to cardiac arrest and at time of follow up. For both out of hospital cardiac arrest survivors and caregivers. Categorical item	6 and 12 months
EuroQol health survey 5 dimensions 5 levels response version (EQ-5D-5L)	Health related quality of life. For both out of hospital cardiac arrest survivors and caregivers. For EQ dimensions score range 1-5 and higher scores=worse indicating more health problems. For EQ VAS score range is 0-100 with higher scores= better and representing higher satisfaction with overall health	12 months for out of hospital cardiac arrest survivors. 6 and 12 months for caregiver
Life satisfaction visual analogue scale from the World Value Survey	Life satisfaction. For both out of hospital cardiac arrest survivors and caregivers. Score range 1-10. Higher scores=better indicating better life satisfaction	6 and 12 months
Timed Stands Test (TST)	Lower extremity strength. For out of hospital cardiac arrest survivors. Raw score adjusted for gender and age and categorized as normal, problems or unable.	6 and 12 months
Jamar hand grip dynamometer	Upper extremity strength. For out of hospital cardiac arrest survivors. Raw scores age and gender adjusted and categorized as normal, problems or unable.	6 and 12 months

Collaborators and Investigators

• Sponsor: Region Skane
• Collaborators: Lund University; Helsinki University Central Hospital; The George Institute for Global Health, Australia; Copenhagen Trial Unit, Center for Clinical Intervention Research

Publications and helpful links

Helpful Links

• Official STEPCARE trial website

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: January 5, 2024
• First Submitted That Met QC Criteria: January 5, 2024
• First Posted (Actual): January 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 23, 2025
• Last Update Submitted That Met QC Criteria: April 17, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cardiovascular Diseases; Heart Diseases; Behavioral Symptoms; Signs and Symptoms, Respiratory; Stress, Psychological; Caregiver Burden; Hypoxia; Heart Arrest; Hypoxia, Brain
• Other Study ID Numbers: extfustep2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Upon resonable request following publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No