BridgeMD
Lessening Organ Dysfunction with VITamin C in septic ARDS
EU CTIS ID: 2024-516394-78-00
What this study is testing
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 ICU patients
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients ≥ 18 years old
- Admitted to the ICU with proven or suspected infection as the main diagnosis
- Currently treated with a continuous intravenous infusion of vasopressors (norepinephrine, epinephrine, vasopressin, dopamine, phenylephrine, angiotensin, others))
- Currently treated with high flow oxygen, CPAP OR NIV OR Invasive Ventilation
- Presenting with Acute Respiratory Distress Syndromedefined by all the following criteria: o Acute onset, i.e. within one week of an apparent clinical insult and with progression of respiratory syndrome o Bilateral opacities on chest imaging not explained by other pulmonary pathologies (e.g. pleural effusion, atelectasis, nodules, etc.) o No evidence for heart failure or volume overload o PaO2/FiO2 ≤ 200 mm Hg o PEEP ≥ 5 cm H2O
- Patient who has signed an informed and written consent whenener he/she is capable of consent, if not, Patient’s representant signed consent whenever he/she is present at inclusion
You likely can't join if
- 48 hours from diagnosis of ARDS
- Received any intravenous vitamin C during this hospitalization unless incorporated in parenteral nutrition (PN) in doses standard for PN
- Expected death or withdrawal of life-sustaining treatments within 48 hours
- Previously enrolled in this study
- Previously enrolled in an interventional trial for which co-enrolment is not allowed (co-enrolment to be determined case by case)
- Patient with critical COVID-19 according WHO definition
See the full eligibility criteria
- Patients ≥ 18 years old
- Admitted to the ICU with proven or suspected infection as the main diagnosis
- Currently treated with a continuous intravenous infusion of vasopressors (norepinephrine, epinephrine, vasopressin, dopamine, phenylephrine, angiotensin, others))
- Currently treated with high flow oxygen, CPAP OR NIV OR Invasive Ventilation
- Presenting with Acute Respiratory Distress Syndromedefined by all the following criteria: o Acute onset, i.e. within one week of an apparent clinical insult and with progression of respiratory syndrome o Bilateral opacities on chest imaging not explained by other pulmonary pathologies (e.g. pleural effusion, atelectasis, nodules, etc.) o No evidence for heart failure or volume overload o PaO2/FiO2 ≤ 200 mm Hg o PEEP ≥ 5 cm H2O
- Patient who has signed an informed and written consent whenener he/she is capable of consent, if not, Patient’s representant signed consent whenever he/she is present at inclusion
- Affiliation to a social security system or to an universal health coverage (Couverture Maladie Universelle, CMU)
- Patients under guardianship or curatorship can be included
- Patients in case of simple emergency (legal definition) or vital emergency will be included
- 48 hours from diagnosis of ARDS
- Received any intravenous vitamin C during this hospitalization unless incorporated in parenteral nutrition (PN) in doses standard for PN
- Expected death or withdrawal of life-sustaining treatments within 48 hours
- Previously enrolled in this study
- Previously enrolled in an interventional trial for which co-enrolment is not allowed (co-enrolment to be determined case by case)
- Patient with critical COVID-19 according WHO definition
- Cardio-pulmonary resuscitation (CPR) in the past 72 hours
- Known Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Pregnancy and breast-feeding
- Hyperoxaluria
- Known allergy excipients of vitamin C solution; or to one of the excipients in particular methyl parhydroxybenzoate (E218) or propyl (E216)
- Treatment with Deferoxamine
- Known kidney stones within the past 1 year
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.