Ignite Creation Date:
2024-07-17 @ 11:12 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06471972
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-18
Brief Title:
Biomarkers After Out-of-hospital Cardiac Arrest- a STEPCARE Substudy
Sponsor:
Region Skane
Organization:
Region Skane
Study Overview
Official Title:
Biomarkers After Out-of-hospital Cardiac Arrest- a STEPCARE Substudy
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A prospective multicenter biomarker study with adult patients treated on
intensive care units after out-of-hospital cardiac arrest Patients will be recruited from specific sites participating in the Sedation Temperature and Pressure After Cardiac Arrest and Resuscitation STEPCARE trial ClinicalTrialsgov ID NCT05564754
Blood samples will be collected at 12 24 48 and 72 hours after randomization in selected sites aliquoted and frozen on-site After trial completion samples will be stored in a central biobank Sample analysis will be performed in batch after trial completion Functional outcome will be assessed at 30 days and 6 months after cardiac arrest
intensive care units after out-of-hospital cardiac arrest Patients will be recruited from specific sites participating in the Sedation Temperature and Pressure After Cardiac Arrest and Resuscitation STEPCARE trial ClinicalTrialsgov ID NCT05564754
Blood samples will be collected at 12 24 48 and 72 hours after randomization in selected sites aliquoted and frozen on-site After trial completion samples will be stored in a central biobank Sample analysis will be performed in batch after trial completion Functional outcome will be assessed at 30 days and 6 months after cardiac arrest
Detailed Description:
A prospective multicenter biomarker study with adult patients treated on intensive care units after out-of-hospital cardiac arrest Patients will be recruited from specific sites participating in the Sedation Temperature and Pressure After Cardiac Arrest and Resuscitation STEPCARE trial ClinicalTrialsgov ID NCT05564754 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
3500 patients who are comatose after cardiac arrest will be included in the STEPCARE trial studying three separate targets All patients will be randomised to a control or an intervention arm for sedation temperature and blood pressure targets as follows
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
Hospitals participating in the STEPCARE trial may opt to participate in the biomarker substudy if they include 20 patientsyear have the possibility to collect and process samples 247 Processing should be done by professional or experienced personnel
Blood samples will be collected at 12 24 48 and 72 hours after randomization in selected sites aliquoted and frozen on-site Serum plasma and PAX-RNA vials are collected After trial completion samples will be stored in a central biobank Sample analysis will be performed in batch after trial completion
Functional outcome will be assessed at 30 days and 6 months after cardiac arrest Primary outcome is poor functional outcome modified Rankin Scale 4-6 at six months Secondary outcomes are poor functional outcome at 30 days and survival at 6 months
3500 patients who are comatose after cardiac arrest will be included in the STEPCARE trial studying three separate targets All patients will be randomised to a control or an intervention arm for sedation temperature and blood pressure targets as follows
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
Hospitals participating in the STEPCARE trial may opt to participate in the biomarker substudy if they include 20 patientsyear have the possibility to collect and process samples 247 Processing should be done by professional or experienced personnel
Blood samples will be collected at 12 24 48 and 72 hours after randomization in selected sites aliquoted and frozen on-site Serum plasma and PAX-RNA vials are collected After trial completion samples will be stored in a central biobank Sample analysis will be performed in batch after trial completion
Functional outcome will be assessed at 30 days and 6 months after cardiac arrest Primary outcome is poor functional outcome modified Rankin Scale 4-6 at six months Secondary outcomes are poor functional outcome at 30 days and survival at 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None