Stepcare Extended Follow-up Substudy

Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06207942
• Other study ID #: extfustep2024
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2024
• Source: Region Skane
• Contact: Gisela Lilja, PhD
• Phone: +4646176393
• Email: gisela.lilja[@]med.lu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Arrest With Successful Resuscitation
• Caregiver Burden
• Cognitive Impairment
• Heart Arrest
• Hypoxia
• Hypoxia, Brain

Intervention

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
• Deep sedation
Deep sedation for at least 36 hours
• Fever control without a device
Management of fever in the intensive care unit without a device
• Low MAP
A mean arterial blood pressure (MAP) of >65mmHG will be used. Vasopressors will be titrated to this target during 36 hours
• Minimal sedation
A strategy of minimal sedation in the intensive care unit, used only as needed to facilitate transport, imaging and invasive procedures

Locations

Country	Name	City	State
Australia	Princess Alexandra Hospital	Brisbane
Australia	The Sutherland Hospital	Caringbah
Australia	The Prince Charles Hospital	Chermside
Australia	Nepean hospital	Kingswood
Australia	Liverpool hospital	Liverpool
Australia	Royal North Shore Hospital	Sydney
Finland	Helsinki Helsingfors university central hospital	Helsinki
Finland	Tampere university hospital	Tampere
Germany	Universitäres Herzzentrum Lübeck Universitätsklinikum Schleswig-Holstein	Lübeck
Luxembourg	Centre Hospitalier de Luxembourg	Luxembourg
New Zealand	Middlemore hospital	Auckland
New Zealand	Christchurch hospital	Christchurch
New Zealand	Wellington hospital	Wellington
Norway	Oslo university hospital Rikshospitalet	Oslo
Sweden	Sahlgrenska university hospital	Gothenburg
Sweden	Sahlgrenska university hospital	Gothenburg
Sweden	Hallands hospital	Halland
Sweden	Helsingborg hospital	Helsingborg
Sweden	Skåne university hospital	Lund
Sweden	Skåne university hopsital	Malmö
Switzerland	Kantonsspital St. Gallen	Saint Gallen
United Kingdom	University hospital of Wales	Cardiff

Sponsors (5)

Lead Sponsor	Collaborator
Region Skane	Copenhagen Trial Unit, Center for Clinical Intervention Research, Helsinki University Central Hospital, Lund University, The George Institute for Global Health, Australia

Countries where clinical trial is conducted

Australia,  Finland,  Germany,  Luxembourg,  New Zealand,  Norway,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	Montreal Cognitive Assessment (MoCA)	Cognitive function for out of hospital cardiac arrest survivors. Score range. Higher scores=better cognition	6 months
Primary	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

External Links

•   Official STEPCARE trial website