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

Who is this study for? Patients with Septic, Acute Respiratory Distress Syndrome
What treatments are being studied? Vitamin C
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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 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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Department Intensive Care Unit, Hospital Raymond Poincaré - APHP
RECRUITING
Garches
Contact Information
Primary
Djillali ANNANE, MD, PhD
djillali.annane@aphp.fr
+33 1 47 10 77 87
Time Frame
Start Date: 2022-07-22
Estimated Completion Date: 2024-07
Participants
Target number of participants: 800
Treatments
Experimental: Experimental arm
vitamin C 50 mg/kg every 6 hours for 96 hours.
Placebo_comparator: Control arm
Placebo administration
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov

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