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Efficacy of Early Intravenous High-dose Vitamin C in Post-cardiac Arrest Shock. (VICEPAC)

Primary Purpose

Cardiac Arrest

Status
Not yet recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Vitamin C (Laroscorbine) + Vitamin B1 (Bevitine)
standard treatment
Sponsored by
Centre Hospitalier de Bethune
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: nclusion criteria: 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. Exclusion criteria: minor or pregnant women; OHCA from evident extracardiac cause (trauma, bleeding, poisoning, etc.); interval between OHCA and randomization > 6 hours; extracorporeal circulatory assistance requirement in the first 4 hours after OHCA; history of urolithiasis, oxalate nephropathy or hemochromatosis; glucose-6-phosphate deshydrogenase deficiency; nephrolithiasis, hyperoxalyurie patients already treated with vit-C; known vit-C deficit; inclusion in another study; 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

Sites / Locations

  • Centre Hospitalier Universitaire d'Amiens
  • Centre Hospitalier Béthune
  • Centre Hospitalier de Dieppe
  • GHEF Site Marne La Vallée
  • Centre Hospitalier de LENS
  • Centre Hospitalier Universitaire de LILLE
  • Centre Hospitalier de Rouen
  • Centre Hospitalier Toulon La Seyne sur Mer
  • Centre Hospitalier de Valenciennes

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Experimental group

Arm Description

- 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 (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.

Outcomes

Primary Outcome Measures

Cumulative incidence of weaning from vasopressors at day 3 after OHCA.
Cumulative incidence of weaning from vasopressors at day 3 after OHCA.

Secondary Outcome Measures

Cumulative incidence of death by refractory shock within 7 days after OHCA.
Cumulative incidence of death by refractory shock within 7 days 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).
The maximal vasopressors infusion dose within 3 days after OHCA.
The maximal vasopressors infusion dose within 3 days 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).
The lower arterial lactate level at day 3 after OHCA.
The lower arterial lactate level at day 3 after OHCA.

Full Information

First Posted
March 23, 2023
Last Updated
August 24, 2023
Sponsor
Centre Hospitalier de Bethune
Collaborators
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer, University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT05817851
Brief Title
Efficacy of Early Intravenous High-dose Vitamin C in Post-cardiac Arrest Shock.
Acronym
VICEPAC
Official Title
Efficacy of Early Intravenous High-dose Vitamin C in Post-cardiac Arrest Shock: a Multicenter, Randomized Controled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
September 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier de Bethune
Collaborators
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer, University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
234 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
- 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.
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
- 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.
Intervention Type
Drug
Intervention Name(s)
Vitamin C (Laroscorbine) + Vitamin B1 (Bevitine)
Other Intervention Name(s)
Laroscorbine + Bevitine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
standard treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cumulative incidence of weaning from vasopressors at day 3 after OHCA.
Description
Cumulative incidence of weaning from vasopressors at day 3 after OHCA.
Time Frame
day 3
Secondary Outcome Measure Information:
Title
Cumulative incidence of death by refractory shock within 7 days after OHCA.
Description
Cumulative incidence of death by refractory shock within 7 days after OHCA.
Time Frame
day 7 after OHCA
Title
the neurological outcome at day 28 after OHCA, with mRS range from 0 to 3.
Description
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).
Time Frame
day 28 after OHCA
Title
The maximal vasopressors infusion dose within 3 days after OHCA.
Description
The maximal vasopressors infusion dose within 3 days after OHCA.
Time Frame
72 hours after OHCA
Title
The delta SOFA (sepsis-related organ failure assessment score) is defined as the difference between SOFA admission and SOFA at 72 hours after OHCA.
Description
Death within 72 hours will be counted as the maximum SOFA score (i.e. 24 points).
Time Frame
72 hours after OHCA
Title
The lower arterial lactate level at day 3 after OHCA.
Description
The lower arterial lactate level at day 3 after OHCA.
Time Frame
72 hours after OHCA

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: nclusion criteria: 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. Exclusion criteria: minor or pregnant women; OHCA from evident extracardiac cause (trauma, bleeding, poisoning, etc.); interval between OHCA and randomization > 6 hours; extracorporeal circulatory assistance requirement in the first 4 hours after OHCA; history of urolithiasis, oxalate nephropathy or hemochromatosis; glucose-6-phosphate deshydrogenase deficiency; nephrolithiasis, hyperoxalyurie patients already treated with vit-C; known vit-C deficit; inclusion in another study; 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christophe VINSONNEAU
Phone
03.21.64.44.44
Email
cvinsonneau@ch-bethune.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan CHELLY
Facility Information:
Facility Name
Centre Hospitalier Universitaire d'Amiens
City
Amiens
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien MAIZEL
Facility Name
Centre Hospitalier Béthune
City
Béthune
ZIP/Postal Code
62408
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MELANIE VERLAY
Phone
0602013068
Email
mverlay@ch-lens.fr
First Name & Middle Initial & Last Name & Degree
Christophe VINSONNEAU
Facility Name
Centre Hospitalier de Dieppe
City
Dieppe
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marion BEUZELIN
Facility Name
GHEF Site Marne La Vallée
City
Jossigny
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ly Van Phach VONG
Facility Name
Centre Hospitalier de LENS
City
Lens
ZIP/Postal Code
62307
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MELANIE VERLAY
Phone
0601023068
Email
mverlay@ch-lens.fr
First Name & Middle Initial & Last Name & Degree
Olivier NIGEON
Facility Name
Centre Hospitalier Universitaire de LILLE
City
Lille
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sébastien PREAU
Facility Name
Centre Hospitalier de Rouen
City
Rouen
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabienne TAMION
Facility Name
Centre Hospitalier Toulon La Seyne sur Mer
City
Toulon
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan CHELLY
Facility Name
Centre Hospitalier de Valenciennes
City
Valenciennes
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabien LAMBIOTTE

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of Early Intravenous High-dose Vitamin C in Post-cardiac Arrest Shock.

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