Efficacy of early intravenous high-dose vitamin C in post-cardiac arrest shock: a multicenter, randomized controled to standard treatment, open label trial.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Bethune Beuvry

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

27 Dec 2023 → ongoing

Decision date (initial)

2023-03-21

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

Our main objective is to assess the efficacy of IV high-dose vit-C to reduce the need for vasopressor within the first 3 days in patients who suffered from an OHCA with a post-CA shock.

Secondary objectives 5

1. Compare between two groups the hospital mortality related to post-CA shock within the first 7 day after OHCA
2. Compare between two groups the survival with good neurological outcome at day 28 after OHCA.
3. Compare between two groups the maximal dose of catecholamin infusion within the first 3 day after OHCA.
4. Compare between two groups organ failure within the first 3 days after OHCA.
5. Compare between two groups arterial lactate level within the first 3 days after OHCA

Conditions and MedDRA coding

cardiac arrest

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. patients still comatose (Glasgow coma scale < 8)
2. an OHCA of presumed cardiac origin with ROSC < 60 min
3. 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 17

1. minor
2. pregnant women
3. OHCA from evident extracardiac cause (trauma, bleeding, poisoning, etc..)
4. interval between OHCA and randomization > 4 hours
5. extracorporeal circulatory assistance requirement in the first 4 hours after OHCA
6. Hypersensitivity of active substance or méthyl parahydroxybenzoate or dipropyl
7. Contraindication to vitamine C (glucose-6-phosphate deshydrogenase deficiency; hemochromatosis)
8. patients already treated with vit-C;
9. inclusion in another interventional study in cardiac arrest or post CA
10. pre-existent severe chronic kidney disease (glomerular filtration rate < 30ml/min)
11. moribound or chronic disease (life expectancy <1 an).
12. Patient with legal protective measures
13. Patient not covered by French national health insurance
14. known vit-C deficit
15. Patient with derpived freedom
16. Hyperoxaluria
17. Hystory of urolithiasis

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 5

1. Cumulative incidence of death by refractory shock within 7 days after OHCA.
2. the neurological outcome at day 28 after OHCA, 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).
3. The maximal vasopressors infusion dose within 3 days after OHCA.
4. 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).
5. The lower arterial lactate level at day 3 after OHCA.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Bethune Beuvry

Sponsor organisation

Centre Hospitalier Bethune Beuvry

Address

27 Rue Delbecque

City

Beuvry

Postcode

62660

Country

France

Scientific contact point

Organisation

Centre Hospitalier Bethune Beuvry

Contact name

Coordinating Investigator

Public contact point

Organisation

Centre Hospitalier Bethune Beuvry

Contact name

project manager

Locations

1 EU/EEA country · 14 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 22 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications