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| Name | Class |
|---|---|
| Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer | OTHER |
| University Hospital, Lille | OTHER |
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Among patients admitted after an out-of-hospital cardiac arrest (OHCA) in intensive care unit (ICU), almost two thirds of patients will develop in the first hours a post-cardiac arrest (CA) shock. This post-CA shock, combines cardiac and hemodynamic failure, generally resulting in multi-organ failure and early death in up to 35% of patients. Experimental data suggest that intravenous ascorbic acid (vitamin C) may attenuate inflammation and vascular injury related to sepsis or surgery. Preclinical and clinical studies also provide safety data of high dose intravenous vitamin C (> 200mg/kg/day) with no significant adverse event reported and favorable impact on outcome. Experimental data also suggest beneficial effect of vitamin C in post-CA management with improvement of shock and multi-organ failure with potential benefit on neuroprotection and outcome.
The study is a phase II multicenter prospective controlled open-label trial randomized in two parallel groups :
Patient number to be enrolled : 234, Study duration :24 months and 28 days, Inclusion duration : 24 months, Patient participation : duration : 28 days
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | - Control group (standard treatment): post-cardiac arrest care will be provided, including temperature control, according to current international guidelines and local procedures. Standard IV vit-C supplementation will be allowed for dosages up to 1000 mg a day from day 4 after randomization, as well as thiamin supplementation. |
|
| Experimental group | Experimental | - Experimental group (IV high-dose vit-C): in addition of standard post-CA as the control group, patients will receive an IV high-dose vit-C 50mg/kg infusion every 6 hours, started within the hour after randomization, for 3 days. In addition, all patients will receive intravenous thiamine 200 mg twice a day for 3 days to limit the oxalate production. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin C (Laroscorbine) + Vitamin B1 (Bevitine) | Drug | in addition of standard post-CA as the control group, patients will receive an IV high-dose vit-C 50mg/kg infusion every 6 hours, started within the hour after randomization, for 3 days. In addition, all patients will receive intravenous thiamine 200 mg twice a day for 3 days to limit the oxalate production. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of weaning from vasopressors at day 3 after OHCA. | Cumulative incidence of weaning from vasopressors at day 3 after OHCA. | day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of death by refractory shock within 7 days after OHCA. | Cumulative incidence of death by refractory shock within 7 days after OHCA. | day 7 after OHCA |
| the neurological outcome at day 28 after OHCA, with mRS range from 0 to 3. |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonathan CHELLY | Contact | 04.94.14.51.24 | jonathan.chelly@ch-toulon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire d'Amiens | Active, not recruiting | Amiens | France | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39317492 | Derived | Chelly J, Peres N, Sboui G, Maizel J, Beuzelin M, Nigeon O, Preau S, Vong LVP, Tamion F, Lambiotte F, Deye N, Bertrand T, Behal H, Ducros L, Vinsonneau C. Early intravenous high-dose vitamin C in postcardiac arrest shock (VICEPAC): study protocol for a randomised, single-blind, open-label, multicentre, controlled trial. BMJ Open. 2024 Sep 24;14(9):e087303. doi: 10.1136/bmjopen-2024-087303. |
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The study is a phase II multicenter prospective controlled open-label trial randomized in two parallel groups :
Patient number to be enrolled : 234, Study duration :24 months and 28 days, Inclusion duration : 24 months, Patient participation : duration : 28 days
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|
|
| standard treatment | Drug | no intervention Standard IV vit-C supplementation will be allowed for dosages up to 1000 mg a day from day 4 after randomization, as well as thiamin supplementation. |
|
Assessed using the mRS (favorable neurological outcome will be considered if mRS range from 0 to 3; Unfavorable neurological outcome will be considered if mRS range from 4 to 6).
| day 28 after OHCA |
| The maximal vasopressors infusion dose within 3 days after OHCA. | The maximal vasopressors infusion dose within 3 days after OHCA. | 72 hours after OHCA |
| The delta SOFA (sepsis-related organ failure assessment score) is defined as the difference between SOFA admission and SOFA at 72 hours after OHCA. | Death within 72 hours will be counted as the maximum SOFA score (i.e. 24 points). | 72 hours after OHCA |
| The lower arterial lactate level at day 3 after OHCA. | The lower arterial lactate level at day 3 after OHCA. | 72 hours after OHCA |
| CH d'Arras |
| Recruiting |
| Arras |
| France |
|
| Centre Hospitalier Béthune | Recruiting | Béthune | 62408 | France |
|
| CHI Nord-Ardennes | Active, not recruiting | Charleville-Mézières | France |
| Centre Hospitalier de Dieppe | Recruiting | Dieppe | France |
|
| GHEF Site Marne La Vallée | Recruiting | Jossigny | France |
|
| Centre Hospitalier de LENS | Recruiting | Lens | 62307 | France |
|
| Centre Hospitalier Universitaire de LILLE | Recruiting | Lille | France |
|
| CH de Melun (GHSIF) | Active, not recruiting | Melun | France |
| Hôpital Lariboisière | Recruiting | Paris | 75475 | France |
|
| Centre Hospitalier de Rouen | Recruiting | Rouen | France |
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| Centre Hospitalier Toulon La Seyne sur Mer | Recruiting | Toulon | France |
|
| Centre Hospitalier de Valenciennes | Active, not recruiting | Valenciennes | France |
| CH de Versailles | Not yet recruiting | Versailles | France |
|
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| D013831 | Thiamine |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
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