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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 study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire d’Orléans Orléans France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier De Dax Dax France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Centre Hospitalier de Dieppe Dieppe France
Centre Hospitalier Intercommunal De Mont De Marsan Et Du Pays Des Sources Mont-de-Marsan France
Cadxlh Hitcnpelojq Soy Ejazbstrbnaqowqedqlexro Etampes France
Cpkiuc Hjzcggfitaq Eo Udskrkjtqzjss Dv Lorxnuw Limoges France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
06.07.2022

Trial locations

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.

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 ID:
2024-516394-78-00
Protocol code:
APHP200019
NCT ID:
NCT04404387
Trial Phase:
Therapeutic confirmatory (Phase III)

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