Using high-dose vitamin C to improve outcomes in patients with septic ARDS

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

This study is testing if giving high doses of vitamin C can help people in intensive care with septic ARDS feel better and survive longer compared to those who get a placebo.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 800 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (Academic / other)
• Locations: 1 site (Garches)
• Trial ID: NCT04404387 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of high-dose intravenous vitamin C compared to a placebo in patients suffering from septic Acute Respiratory Distress Syndrome (ARDS) in intensive care units. The primary goal is to assess the impact on mortality and persistent organ dysfunction over a 28-day period. Secondary objectives include evaluating long-term mortality, quality of life, organ function, and specific complications such as acute kidney injury. The study will enroll approximately 4,000 patients across multiple countries, utilizing a randomized controlled design to ensure robust data collection and analysis.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are admitted to the ICU with proven or suspected infections and presenting with septic ARDS.

Not a fit: Patients who have been in the ICU for more than 24 hours or have specific contraindications such as G6PD deficiency or pregnancy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce mortality and improve organ function in critically ill patients with septic ARDS.

How similar studies have performed: Preliminary evidence suggests potential benefits of vitamin C in sepsis treatment, but this study aims to provide definitive data, making it a novel and critical investigation.

Eligibility criteria

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.

Exclusion Criteria:

* \> 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).

Where this trial is running

Garches

• Department Intensive Care Unit, Hospital Raymond Poincaré - APHP — Garches, France (Recruiting)

Study contacts

• Principal investigator: Djillali ANNANE, MD, PhD — Department Intensive Care Unit, Hospital Raymond Poincaré - APHP
• Study coordinator: Djillali ANNANE, MD, PhD

Conditions Septic; Acute Respiratory Distress Syndrome; Acute respiratory distress syndrome; Vitamin C