KCE-191237: Early administration of Vitamin C in patients with sepsis or septic shock in emergency departments: a multicentre, double blinded, randomized controlled trial - C-EASIE

Summary (French or Dutch)

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.

Trial Description
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)

Participants (P)

Patients presenting with sepsis or septic shock in the Emergency Department

Intervention (I)

Ascorbic Acid 1.5g IV in 50ml Normal Saline every 6hrs, started within 6hrs after presentation at the emergency department

Control (C)

Placebo (Normal Saline 50ml every 6hrs)

Outcome (O)

Average post-baseline patient SOFA score (on day 1 - 5 after patient inclusion)

Trial Design

Randomized, Double Blinded, Multicentre Controlled Trial

Sample Size

300

Trial duration

27 months

Budget

€1 250 000 EUR

Status

Open

 

Trial team

Sponsor

UZ Leuven

Chief Investigator

Didier Desruelles (replacing Stefanie Vandervelden)

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)

External partner

none

Documents
Protocol  
Report

Q2/2023

Publication

 

References

Clinicaltrials.gov: pending

EudraCT: 2020-001862-12

Webpage: 

Funding scheme

2019 Investigator led