Informations générales (source: ClinicalTrials.gov)
A Multicentre Concealed-Allocation Parallel-Group Blinded Randomized Controlled Trial to Ascertain the Effect of High-Dose Intravenous Vitamin C Compared to Placebo on Mortality or Persistent Organ Dysfunction at 28 Days in Septic Intensive Care Unit Patients
Interventional
Phase 3
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
juillet 2022
juillet 2024
13 septembre 2025
The primary objective of the study aims to compare the effect of high-dose intravenous
vitamin C vs. placebo on a composite of death or persistent organ dysfunction - defined
as continued dependency on mechanical ventilation, new renal replacement therapy, or
vasopressors - assessed at 28 days on intensive care unit (ICU) patients.
As secondary objectives, the study aims:
- To compare the effect of high-dose intravenous vitamin C vs. placebo on:
1. 6-month mortality;
2. 6-month HRQoL;
3. organ function (days 1, 2, 3, 4, 7, 10, 14, and 28 if in ICU);
4. global tissue dysoxia (at baseline);
5. oxygenation Index (FiO2 x Mean Airway Pressure/PaO2) (days 1, 2, 3, 4, 7, 10,
14, and 28 if in ICU, and if still intubated);
6. occurrence of stage 3 acute kidney injury as defined by KDIGO (Kidney Disease:
Improving Global Outcomes) criteria20;
7. acute hemolysis as defined by:
- clinician judgment of hemolysis, as recorded in the chart, or
- hemoglobin drop of at least 25 g/L within 24 hours of a dose of
investigational product PLUS 2 of the following:
- reticulocyte count >2 times upper limit of normal at clinical site
lab;
- haptoglobin < lower limit of normal at clinical site lab;
- indirect (unconjugated) bilirubin >2 times upper limit of normal at
clinical site lab;
- lactate dehydrogenase (LDH) >2 times upper limit of normal at
clinical site lab.
Severe hemolysis:
- hemoglobin < 75 g/L AND at least 2 of the above criteria AND requires 2
units of packed red blood cells;
8. hypoglycemia as defined as core lab-validated glucose levels of less than < 3.8
mmol/L.
- To assess baseline vitamin C levels in study participants (before the first dose of
investigational product).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CH SUD ESSONNE-DOURDAN-ETAMPES | ANNANE Djillali | 13/12/2025 07:25:53 | Contacter | ||
| AP-HP Assistance publique - Hôpitaux de Paris | 13/12/2025 07:25:53 | Contacter | |||
| AP-HP - Hôpital Bichat | |||||
| AP-HP - Hôpital Cochin | |||||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | |||||
| AP-HP - Hôpital La Pitié-Salpêtrière | |||||
| AP-HP - Hôpital Lariboisiere-Fernand Widal | |||||
| AP-HP - Hôpital Raymond Poincaré | |||||
| AP-HP - Hôpital Tenon | |||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Department Intensive Care Unit, Hospital Raymond Poincaré - APHP - 92100 - Garches - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Patients ≥18 years;
- Admitted to ICU with proven or suspected infection as the main diagnosis;
- Currently treated with a continuous intravenous infusion of vasopressors
(norepinephrine, epinephrine, vasopressin, dopamine, phenylephrine);
- Presenting with Acute Respiratory Distress Syndrome
- Patient who has signed an informed and written consent, whenever he/she is capable
of consent, if not ascent from his/her representant whenever he/she is present at
time of screening for inclusion
- Affiliation to a social security system or to an universal health coverage
(Couverture Maladie Universelle, CMU).
- Patients under guardianship or curatorship will be included.
- Patients in case of simple emergency (legal definition) will be included.
- Patients ≥18 years;
- Admitted to ICU with proven or suspected infection as the main diagnosis;
- Currently treated with a continuous intravenous infusion of vasopressors
(norepinephrine, epinephrine, vasopressin, dopamine, phenylephrine);
- Presenting with Acute Respiratory Distress Syndrome
- Patient who has signed an informed and written consent, whenever he/she is capable
of consent, if not ascent from his/her representant whenever he/she is present at
time of screening for inclusion
- Affiliation to a social security system or to an universal health coverage
(Couverture Maladie Universelle, CMU).
- Patients under guardianship or curatorship will be included.
- Patients in case of simple emergency (legal definition) will be included.
- > 24 hours of intensive care unit (ICU) admission;
- Known Glucose-6-phosphate dehydrogenase (G6PD) deficiency;
- Pregnancy;
- Known allergy to vitamin C;
- Known kidney stones within the past 1 year;
- Received any intravenous vitamin C during this hospitalization unless incorporated
in parenteral nutrition;
- Expected death or withdrawal of life-sustaining treatments within 48 hours;
- Previously enrolled in this study;
- Previously enrolled in a trial for which co-enrolment is not allowed (co-enrolment
to be determined case by case).