Ignite Creation Date:
2024-07-17 @ 10:55 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06473207
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-17
Brief Title:
Neuroprotective Effect of Remote Ischemic Post-conditioning in Out-of-hospital Cardiac Arrest
Sponsor:
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Organization:
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Study Overview
Official Title:
Neuroprotective Effect of Remote Ischemic Post-conditioning in Out-of-hospital Cardiac Arrest a Randomized Open Label Controlled Trial
Status:
NOT_YET_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:
RIPOST-CA
Brief Summary:
Patients admitted to intensive care unit ICU following an out-of-hospital cardiac arrest OHCA have a high morbidity and mortality rate primarily due to ischemia-reperfusion IR syndrome leading to anoxic-ischemic brain injury Despite current recommended advanced life support therapies no specific treatment or procedure has yet been shown to improve the neurological outcome of such patients
Remote ischemic post-conditioning RIPOST which usually consists of applying brief and repeated cycles of ischemia alternating with reperfusion by inflating and deflating a blood pressure cuff or a pneumatic tourniquet placed around a limb is a promising strategy to protect organs against IR injury including brain Regarding cardiac arrest pre-clinical studies have demonstrated an improvement in neurological outcome in animal subjects treated with RIPOST after cardiopulmonary resuscitation
The aim of our study is to demonstrate the benefit of early RIPOST in OHCA patients in reducing neurological injury and organ failure related to IR syndrome
Remote ischemic post-conditioning RIPOST which usually consists of applying brief and repeated cycles of ischemia alternating with reperfusion by inflating and deflating a blood pressure cuff or a pneumatic tourniquet placed around a limb is a promising strategy to protect organs against IR injury including brain Regarding cardiac arrest pre-clinical studies have demonstrated an improvement in neurological outcome in animal subjects treated with RIPOST after cardiopulmonary resuscitation
The aim of our study is to demonstrate the benefit of early RIPOST in OHCA patients in reducing neurological injury and organ failure related to IR syndrome
Detailed Description:
The RIPOST trial is a prospective single-center randomized open-label parallel group trial
Patients with inclusion criteria will be randomized in two parallel groups
Experimental group standard of care associated to 3 RIPOST sessions one within the 4 hours following cardiac arrest one 12 hours after cardiac arrest and one 24 hours after cardiac arrest A RIPOST session four cycles of cuff inflation to 200 mmHg for five minutes and then deflation to 0 mmHg for another five minutes using an inflatable thigh tourniquet total duration of the session 40 minutes
Control group standard of care associated to 3 sham sessions at inclusion 24 and 48 hours after inclusion A sham session application of the thigh tourniquet during 40 minutes without any inflation
Inclusion duration 24 months
Patient participation duration 3 months
Study duration 27 months
Patients with inclusion criteria will be randomized in two parallel groups
Experimental group standard of care associated to 3 RIPOST sessions one within the 4 hours following cardiac arrest one 12 hours after cardiac arrest and one 24 hours after cardiac arrest A RIPOST session four cycles of cuff inflation to 200 mmHg for five minutes and then deflation to 0 mmHg for another five minutes using an inflatable thigh tourniquet total duration of the session 40 minutes
Control group standard of care associated to 3 sham sessions at inclusion 24 and 48 hours after inclusion A sham session application of the thigh tourniquet during 40 minutes without any inflation
Inclusion duration 24 months
Patient participation duration 3 months
Study duration 27 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A02457-38 | OTHER | None | None |