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Study of High-Dose Vitamin C (Ascorbic Acid) Compared to Placebo in Patients with Sepsis and Acute Respiratory Distress Syndrome (ARDS) in Intensive Care

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients with sepsis complicated by Acute Respiratory Distress Syndrome (ARDS), a severe condition where the lungs become severely inflamed and cannot provide enough oxygen to the body. The study examines whether high-dose vitamin C given through an intravenous line can help improve outcomes for patients in intensive care units who are receiving breathing support and medications to maintain blood pressure.

The treatment being tested involves giving patients either high doses of Laroscorbine (vitamin C solution) or sodium chloride solution (placebo) through their veins for 4 days. The vitamin C dose used in this study is higher than what is normally given to patients. Both solutions will be given as an injection or infusion directly into the bloodstream.

The purpose of this research is to determine if high-dose vitamin C can reduce the chances of death or ongoing organ problems in patients with severe sepsis and ARDS. Organ problems include the continued need for breathing machines, medications to maintain blood pressure, or special filtering of the blood when kidneys are not working properly. Patients will be monitored for 28 days to see how the treatment affects their recovery.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment and admission

    You will be admitted to the Intensive Care Unit (ICU) with a suspected or confirmed infection

    Medical staff will verify that you meet the requirements, including being at least 18 years old and having specific breathing difficulties

    You will be receiving continuous medication through an IV line to maintain blood pressure (vasopressors)

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either vitamin C or a placebo (inactive substance)

    Neither you nor your healthcare providers will know which treatment you are receiving

    The treatment will be given through an intravenous line (IV)

  3. Step 3

    Ongoing treatment and monitoring

    You will continue to receive breathing support through various methods, which may include a breathing machine

    Your organ function will be monitored continuously

    Medical staff will track your need for breathing support, kidney support, and blood pressure medications

  4. Step 4

    28-day assessment period

    Your progress will be monitored for 28 days

    Medical staff will document whether you still require breathing support, kidney support, or blood pressure medications

    Your overall health status will be evaluated at the end of this period

Who can join the trial?

9 criteria

  • Must be at least 18 years old
  • Must be in the Intensive Care Unit (ICU) with confirmed or suspected infection as the main diagnosis
  • Must be receiving continuous intravenous blood pressure support medications (vasopressors) through an IV line
  • Must be receiving breathing support through either: - High-flow oxygen therapy - CPAP (continuous positive airway pressure) - NIV (non-invasive ventilation) - Invasive ventilation (breathing machine through a tube)
  • Must have Acute Respiratory Distress Syndrome with all these conditions: - Symptoms started within one week of a known medical problem - Lung imaging shows shadows on both sides - No signs of heart failure - Specific oxygen level measurements meeting required criteria - Using specific breathing support settings
  • Must be able to provide written informed consent, or have a representative who can provide consent
  • Must have health insurance or universal health coverage
  • Can participate if under legal guardianship or custodianship
  • Can be included in emergency situations, including life-threatening emergencies

Who cannot join the trial?

12 criteria

  • Age below 18 years or above 65 years
  • Known allergic reaction to vitamin C supplements
  • Current participation in other clinical trials
  • Not diagnosed with both sepsis (severe infection affecting the whole body) and ARDS (acute respiratory distress syndrome - severe breathing difficulty)
  • Pregnant or breastfeeding women
  • Patients with kidney failure requiring dialysis before hospital admission
  • Patients with severe liver disease
  • Patients with terminal illness with life expectancy less than 28 days
  • Unable to receive intravenous medication
  • History of kidney stones
  • Patients who received vitamin C supplements in doses higher than 1000mg/day within the past week
  • Unable to provide informed consent (either directly or through a legal representative)
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Investigated drugs

  • Vitamin C (Ascorbic Acid)

    This is a vitamin that is given through an intravenous (IV) line directly into the bloodstream at high doses. In this trial, it is being studied for its potential benefits in critically ill patients who have severe breathing problems and sepsis (a serious infection affecting the whole body). Vitamin C is an antioxidant that may help protect cells from damage and support the immune system during severe illness.

  • Placebo

    A harmless substance that looks identical to the active treatment but contains no active medication. It is used to compare the effects of the real treatment and help determine if Vitamin C actually makes a difference in patient outcomes.

What is already known about the treatment

Vitamin C (Ascorbic Acid) – A water-soluble vitamin administered intravenously in high doses for critically ill patients, particularly those with sepsis and Acute Respiratory Distress Syndrome (ARDS). This essential nutrient acts as a powerful antioxidant, helping to reduce oxidative stress and inflammation in the body, while also supporting immune system function and tissue repair. In clinical settings, high-dose intravenous vitamin C is being investigated for its potential to improve outcomes in intensive care patients by reducing organ dysfunction and mortality, with administration typically performed through a controlled intravenous infusion. The substance is classified as a vital nutrient and antioxidant supplement, with growing research interest in its therapeutic applications for critical care medicine.

Investigated diseases

  • Sepsis

    A severe condition that occurs when the body's response to infection causes injury to its own tissues and organs. It develops when the chemicals released into the bloodstream to fight an infection trigger widespread inflammation. This condition can progress rapidly, causing changes in blood pressure, heart rate, and breathing. Sepsis can affect multiple organ systems, leading to their dysfunction.

  • Acute Respiratory Distress Syndrome (ARDS)

    A serious lung condition that develops when fluid builds up in the tiny, elastic air sacs (alveoli) in the lungs. This fluid buildup prevents the lungs from filling with enough air, resulting in less oxygen reaching the bloodstream. The condition develops rapidly and makes breathing increasingly difficult. ARDS typically occurs in people who are already critically ill or who have significant injuries.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516394-78-00Protocol codeAPHP200019Estimated enrolment814 patientsSponsorAssistance Publique Hopitaux De Paris

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