Vitamin C, also known as ascorbic acid, is a vitamin found in various foods. After almost a century of in vitro experiments and animal based studies, there is an abundance of plausible data for the protective effects of Vitamin C. Also its safety has been well established over the years.
Sepsis is a potentially life-threatening condition characterized by a deregulated body’s response to infection causing injury to its own tissues and organs. It is the primary cause of death from infection, especially if not recognized and treated timely. Untreated it can evolve within minutes/hours to septic shock. It is associated with an acute deficiency of Vitamin C and studies have reported that high doses of intravenous Vitamin C could reduce organ injury and improve survival.
With the C-EASIE trial, the investigators plan to conduct a prospective, multicentre, randomised, double blinded trial in patients presenting at the emergency department with sepsis or septic shock to test whether the early intravenous administration of high doses of Vitamin C (1.5 g bolus, 4 times a day during 4 days) can prevent deterioration from sepsis to septic shock or lead to a more rapid solution of the when compared to placebo. If positive, the early administration of Vitamin C could result in a faster patient recovery and shorter length of hospital stay.
| Summary of results |
|---|
| After processing the results, we can conclude that vitamin C administration did not result in a less severe course of disease or a faster recovery. Five days after hospital admission, the SOFA score (used to assess organ failure) had improved more in patients who had received vitamin C than in those who had received a placebo. Unfortunately, this difference in improvement (8.7%) was too small to be significant. However, sicker patients (i.e. those with a SOFA score of 6 or more at emergency department registration) did benefit from vitamin C. Patients who received vitamin C were also less likely to require kidney replacement therapy (dialysis). There was no positive effect of vitamin C on the duration of hospitalisation or intensive care, the need for ventilation or medication to maintain blood pressure, or on subsequent quality of life. We can therefore conclude that the study could not demonstrate that vitamin C should be administered by default to all patients admitted to the emergency department with symptoms of sepsis or septic shock. |
| Title |
Early administration of Vitamin C in patients with sepsis or septic shock in emergency departments: a multicentre, double blinded, randomized controlled trial (C-EASIE) |
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Participants (P) |
Patients presenting with sepsis or septic shock in the Emergency Department |
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Intervention (I) |
Ascorbic Acid 1.5g IV in 50ml Normal Saline every 6hrs, started within 6hrs after presentation at the emergency department |
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Control (C) |
Placebo (Normal Saline 50ml every 6hrs) |
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Outcome (O) |
Average post-baseline patient SOFA score (on day 1 - 5 after patient inclusion) |
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Trial Design |
Randomized, Double Blinded, Multicentre Controlled Trial |
|
Sample Size |
300 |
|
Trial duration |
27 months |
|
Budget |
€1 250 000 EUR |
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Sponsor |
UZ Leuven |
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Chief Investigator |
Didier Desruelles (replacing Stefanie Vandervelden) |
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Participating sites and Investigators |
UZ Leuven - Dr Didier Desruelles Centre Hospitalier Universitaire de Liège - Dr Alexandre Ghuysen Universitair Ziekenhuis Antwerpen (UZA) - Dr. Koen Monsieurs University Hospital Brussels - Dr. Evert Verhoeven Algemeen Ziekenhuis Turnhout - Dr. Jan Breuls GZA - Dr Stefanie Vandervelden Clinique Universitaire St Pierre Bruxelles - Dr Pierre Mols (TBC) Clinique Saint Pierre Ottignies (TBC) |
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External partner |
none |
2019 Investigator led
