Cardiac ArrestPhase 2VICEPACNCT05817851
Efficacy of Early Intravenous High-dose Vitamin C in Post-cardiac Arrest Shock.
A Phase 2 study testing Vitamin C (Laroscorbine) + Vitamin B1 (Bevitine) and standard treatment in people with Cardiac Arrest, run by Centre Hospitalier de Bethune at 14 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Vitamin C (Laroscorbine) + Vitamin B1 (Bevitine) and standard treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 14 sitesFrance
- Study dates
- 27 Dec 2023to 30 Sep 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients still comatose (Glasgow coma scale < 8) after an OHCA of presumed cardiac origin with ROSC < 60 min;
- and treated with a norepinephrin or an epinephrin continuous infusion during at least 30 min before randomization to maintain mean arterial pressure (MAP) ≥ 65 mmHg.
- pre-existent severe chronic kidney disease (glomerular filtration rate < 30ml/min);
- treatment limitationsor moribound
- Patient with derpived freedom or with legal protective measures.
- Patient not covered by French national health insurance
Who cannot join
- patients still comatose (Glasgow coma scale < 8) after an OHCA of presumed cardiac origin with ROSC < 60 min;
- and treated with a norepinephrin or an epinephrin continuous infusion ≥ 0.2µg/kg/h, within 4 hours after OHCA, during at least 30 min/h to maintain mean arterial pressure (MAP) ≥ 65 mmHg.
- minor or pregnant women;
- OHCA from evident extracardiac cause (trauma, bleeding, poisoning, etc.);
- interval between RACS and randomization > 6 hours;
- extracorporeal circulatory assistance requirement in the first 4 hours after OHCA;
Show all 9Show fewer
- history of urolithiasis, oxalate nephropathy or hemochromatosis;
- glucose-6-phosphate deshydrogenase deficiency; nephrolithiasis, hyperoxalyurie
- patients already treated with vit-C; known vit-C deficit;
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
France14 sites
Centre Hospitalier Universitaire d'Amiens
Amiens
CH d'Arras
Arras
Centre Hospitalier Béthune
Béthune, 62408
CHI Nord-Ardennes
Charleville-Mézières
Centre Hospitalier de Dieppe
Dieppe
GHEF Site Marne La Vallée
Jossigny
Centre Hospitalier de LENS
Lens, 62307
Centre Hospitalier Universitaire de LILLE
Lille
CH de Melun (GHSIF)
Melun
Hôpital Lariboisière
Paris, 75475
Centre Hospitalier de Rouen
Rouen
Centre Hospitalier Toulon La Seyne sur Mer
Toulon
Centre Hospitalier de Valenciennes
Valenciennes
CH de Versailles
Versailles
About this study
Official title: Efficacy of Early Intravenous High-dose Vitamin C in Post-cardiac Arrest Shock: a Multicenter, Randomized Controled Trial.
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 :
Read more
- Expérimental group: Standard of care care for post-CA shock + Vitamin C (Vit-C) 200mg/kg/d IV (started as early as possible, no later than 1 h after randomization + thiamin (Vit B1) 200mg every 12 h during 3 days.
- Control group: Standard of care care for post CA shock according international guidelines.
Patient number to be enrolled : 234, Study duration :24 months and 28 days, Inclusion duration : 24 months, Patient participation : duration : 28 days
- Conditions
- Cardiac Arrest
- Being tested
- Vitamin C (Laroscorbine) + Vitamin B1 (Bevitine), standard treatment
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin C (Laroscorbine) + Vitamin B1 (Bevitine)Drug
Also called Laroscorbine + Bevitine
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: standard treatment |
| 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. Receives: Drug: Vitamin C (Laroscorbine) + Vitamin B1 (Bevitine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of weaning from vasopressors at day 3 after OHCA.
Cumulative incidence of weaning from vasopressors at day 3 after OHCA.
Measured: day 3
Secondary outcomes (5)
Cumulative incidence of death by refractory shock within 7 days after OHCA.
Cumulative incidence of death by refractory shock within 7 days after OHCA.
Measured: day 7 after OHCA
the neurological outcome at day 28 after OHCA, with mRS range from 0 to 3.
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).
Measured: day 28 after OHCA
The maximal vasopressors infusion dose within 3 days after OHCA.
The maximal vasopressors infusion dose within 3 days after OHCA.
Measured: 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).
Measured: 72 hours after OHCA
The lower arterial lactate level at day 3 after OHCA.
The lower arterial lactate level at day 3 after OHCA.
Measured: 72 hours after OHCA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start27 Dec 2023
- Primary completion30 Sep 2026
- Study completion30 Sep 2026
Why it stopped: following new data on vitamin C and at the request of the ANSM
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a phase II multicenter prospective controlled open-label trial randomized in two parallel groups : * Expérimental group * Control group Patient number to be enrolled : 234, Study duration :24 months and 28 days, Inclusion duration : 24 months, Patient participation : duration : 28 days
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Bethune
- Sponsor type
- Research network
- Collaborators
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer, University Hospital, Lille
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817851
- Sponsor's protocol ID
- 2022-01
- Acronym
- VICEPAC
- Status last verified
- Oct 2026
- First submitted
- 23 Mar 2023
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39317492
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Early Intravenous High-dose Vitamin C in Post-cardiac Arrest Shock: a Multicenter, Randomized Controled Trial.
- ClinicalTrials.gov ID
- NCT05817851
- Acronym / sponsor ID
- VICEPAC / 2022-01
- Conditions
- Cardiac Arrest
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: following new data on vitamin C and at the request of the ANSM
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Centre Hospitalier de BethuneResearch network
- Collaborators
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer, University Hospital, Lille
- Study start
- 27 Dec 2023 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- Expérimental group: Standard of care care for post-CA shock + Vitamin C (Vit-C) 200mg/kg/d IV (started as early as possible, no later than 1 h after randomization + thiamin (Vit B1) 200mg every 12 h during 3 days.
- Control group: Standard of care care for post CA shock according international guidelines.
Patient number to be enrolled : 234, Study duration :24 months and 28 days, Inclusion duration : 24 months, Patient participation : duration : 28 days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is a phase II multicenter prospective controlled open-label trial randomized in two parallel groups : * Expérimental group * Control group Patient number to be enrolled : 234, Study duration :24 months and 28 days, Inclusion duration : 24 months, Patient participation : duration : 28 days
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: standard treatment- 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 | Drug: Vitamin C (Laroscorbine) + Vitamin B1 (Bevitine)- 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients still comatose (Glasgow coma scale < 8) after an OHCA of presumed cardiac origin with ROSC < 60 min;
- and treated with a norepinephrin or an epinephrin continuous infusion during at least 30 min before randomization to maintain mean arterial pressure (MAP) ≥ 65 mmHg.
- pre-existent severe chronic kidney disease (glomerular filtration rate < 30ml/min);
- treatment limitationsor moribound
- Patient with derpived freedom or with legal protective measures.
Key exclusion criteria (9 listed)
- patients still comatose (Glasgow coma scale < 8) after an OHCA of presumed cardiac origin with ROSC < 60 min;
- and treated with a norepinephrin or an epinephrin continuous infusion ≥ 0.2µg/kg/h, within 4 hours after OHCA, during at least 30 min/h to maintain mean arterial pressure (MAP) ≥ 65 mmHg.
- minor or pregnant women;
- OHCA from evident extracardiac cause (trauma, bleeding, poisoning, etc.);
- interval between RACS and randomization > 6 hours;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin C (Laroscorbine) + Vitamin B1 (Bevitine)Also: Laroscorbine + Bevitinein 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. | Drug | Experimental group |
| standard treatmentno 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. | Drug | Control group |
Primary outcome
Cumulative incidence of weaning from vasopressors at day 3 after OHCA.
Time frame: day 3
Cumulative incidence of weaning from vasopressors at day 3 after OHCA.
5 secondary outcomes
Cumulative incidence of death by refractory shock within 7 days after OHCA.
Time frame: day 7 after OHCA
the neurological outcome at day 28 after OHCA, with mRS range from 0 to 3.
Time frame: day 28 after OHCA
The maximal vasopressors infusion dose within 3 days after OHCA.
Time frame: 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.
Time frame: 72 hours after OHCA
The lower arterial lactate level at day 3 after OHCA.
Time frame: 72 hours after OHCA
Results and safety
The study was stopped early (reason given: following new data on vitamin C and at the request of the ANSM). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Derived from this study: PubMed 39317492Chelly 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin C (Laroscorbine) + Vitamin B1 (Bevitine) and standard treatment in people with Cardiac Arrest, run by Centre Hospitalier de Bethune at 14 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: following new data on vitamin C and at the request of the ANSM). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of weaning from vasopressors at day 3 after OHCA. (time frame: day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05817851, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.