Status:
RECRUITING
Lessening Organ Dysfunction With VITamin C in Septic ARDS
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Septic
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 o...
Detailed Description
Treatment options for sepsis complicated by ARDS are limited to antimicrobials and supportive care (intravenous fluids, vasopressors, mechanical ventilation and renal replacement therapy). Recent prel...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- \> 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).
Key Trial Info
Start Date :
July 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2024
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT04404387
Start Date
July 22 2022
End Date
July 1 2024
Last Update
January 31 2024
Active Locations (1)
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1
Department Intensive Care Unit, Hospital Raymond Poincaré - APHP
Garches, France, 92100