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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A02457-38 | Other Identifier | Id-RCB |
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| Name | Class |
|---|---|
| French Society for Intensive Care | OTHER |
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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 (I/R) 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 I/R 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 I/R syndrome.
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:
Inclusion duration: 36 months
Patient participation duration: 3 months
Study duration: 39 months
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote ischemic post-conditioning (RIPOST) | Experimental | Patients subjected to three sessions of RIPOST (within the 4 hours following cardiac arrest and then 12 and 24 hours after cardiac arrest) |
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| Sham procedure | Sham Comparator | Patients subjected to three sessions of a sham procedure (within the 4 hours following cardiac arrest and then 12 and 24 hours after cardiac arrest) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote ischemic post conditioning sessions | Other | Three sessions of RIPOST (within the 4 hours following cardiac arrest and then 12 and 24 hours after cardiac arrest), as follows: four cycles of cuff inflation to 200 mmHg for 5 min and then deflation to 0 mmHg for another 5 min (40 min total duration of the intervention), using an inflatable thigh tourniquet |
| Measure | Description | Time Frame |
|---|---|---|
| Neurofilament light chain (NFL) blood level evolution between 6 and 72 hours after cardiac arrest occurrence | Blood samples will be performed at 6 and 72 hours after cardiac arrest to monitor NFL level evolution and this evolution will be compared between both arms (RIPOST and sham groups) | 72 hours after out-of-hospital cardiac arrest occurrence |
| Measure | Description | Time Frame |
|---|---|---|
| Sepsis organ failure assessment score (SOFA) | SOFA will be assessed at 24, 48 and 72 hours after cardiac arrest, and compared between both arms | 72 hours after out-of-hospital cardiac arrest occurrence |
| Rate of patients with NFL peak level >500 pg/mL |
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Inclusion Criteria:
Exclusion criteria :
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chelly Jonathan, MD | Contact | 0494145124 | +33 | Jonathan.chelly@ch-toulon.fr |
| Name | Affiliation | Role |
|---|---|---|
| Chelly Jonathan, MD | Centre Hospitalier Intercommunal Toulon-La Seyne sur Mer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Intercommunal Toulon-La Seyne sur Mer | Recruiting | Toulon | Var | 83100 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32045394 | Background | Ho AFW, Chong J, Ong MEH, Hausenloy DJ. Remote Ischemic Conditioning in Emergency Medicine-Clinical Frontiers and Research Opportunities. Shock. 2020 Mar;53(3):269-276. doi: 10.1097/SHK.0000000000001362. | |
| 31823646 | Background | Kloner RA, Shi J, Dai W, Carreno J, Zhao L. Remote Ischemic Conditioning in Acute Myocardial Infarction and Shock States. J Cardiovasc Pharmacol Ther. 2020 Mar;25(2):103-109. doi: 10.1177/1074248419892603. Epub 2019 Dec 11. |
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| ID | Term |
|---|---|
| D058687 | Out-of-Hospital Cardiac Arrest |
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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| Sham sessions | Other | Three sessions of a sham procedure (within the 4 hours following cardiac arrest and then 12 and 24 hours after cardiac arrest), as follows : application of a thigh tourniquet during 40 min without any inflation |
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Blood samples will be performed at 6, 24, 48 and 72 hours after cardiac arrest to monitor NFL peak level and the rate of patients who will present a NFL peak level > 500 pg/mL will be compared between both arms.
| 72 hours after out-of-hospital cardiac arrest occurrence |
| Neuron-specific enolase (NSE) blood level evolution between 6 and 72 hours after cardiac arrest occurrence | Blood samples will be performed at 6, 24, 48 and 72 hours after cardiac arrest to monitor NSE levels and their evolution will be compared between both arms (RIPOST and sham groups) | 72 hours after out-of-hospital cardiac arrest occurrence |
| S100B protein (PS100B) blood level evolution between 6 and 72 hours after cardiac arrest occurrence | Blood samples will be performed at 6, 24, 48 and 72 hours after cardiac arrest to monitor PS100B levels and their evolution will be compared between both arms (RIPOST and sham groups) | 72 hours after out-of-hospital cardiac arrest occurrence |
| ICU mortality rate from multi-organ failure and from neurological injury | Death mode at ICU discharge will be collected in both arms | At intensive care unit (ICU) discharge, up to 28 days |
| Modified Rankin Scale (mRS) | Modified Rankin Scale (mRS) will be assessed for both arms, at patient's ICU discharge and at day 90 after inclusion. This scales goes from 0 to 6, 0 corresponding to the absence of cognitive deficits and 6 to death. | 90 days after out-of-hospital cardiac arrest occurrence |
| Post out-of-hospital cardiac arrest event occurrence | Post out-of-hospital cardiac arrest event occurrence will be compared between both arms within the 24 hours following cardiac arrest. Events that will be considered are : unexpected cardiac arrest in ICU, iatrogenic events, limb ischemia, occlusive syndrome, digestive ischemia and thromboembolic complications. | 24 hours after out-of-hospital cardiac arrest occurrence |
| 26051813 | Background | Albrecht M, Meybohm P, Broch O, Zitta K, Hein M, Grasner JT, Renner J, Bein B, Gruenewald M. Evaluation of remote ischaemic post-conditioning in a pig model of cardiac arrest: A pilot study. Resuscitation. 2015 Aug;93:89-95. doi: 10.1016/j.resuscitation.2015.05.019. Epub 2015 Jun 4. |
| 31747864 | Background | England TJ, Hedstrom A, O'Sullivan SE, Woodhouse L, Jackson B, Sprigg N, Bath PM. Remote Ischemic Conditioning After Stroke Trial 2: A Phase IIb Randomized Controlled Trial in Hyperacute Stroke. J Am Heart Assoc. 2019 Dec 3;8(23):e013572. doi: 10.1161/JAHA.119.013572. Epub 2019 Nov 21. |
| 30383090 | Background | Moseby-Knappe M, Mattsson N, Nielsen N, Zetterberg H, Blennow K, Dankiewicz J, Dragancea I, Friberg H, Lilja G, Insel PS, Rylander C, Westhall E, Kjaergaard J, Wise MP, Hassager C, Kuiper MA, Stammet P, Wanscher MCJ, Wetterslev J, Erlinge D, Horn J, Pellis T, Cronberg T. Serum Neurofilament Light Chain for Prognosis of Outcome After Cardiac Arrest. JAMA Neurol. 2019 Jan 1;76(1):64-71. doi: 10.1001/jamaneurol.2018.3223. |