NCT04747795: c-easie

Early Administration of Vitamin C in Patients With Sepsis or Septic Shock in Emergency Departments

Completed Phase 3 Last updated 25 January 2024

What this trial tests

Phase 3 trial testing Vitamin C in Sepsis in 301 participants. Completed in 15 November 2023.

Timeline

1 June 2021

Primary endpoint
31 August 2023

15 November 2023

Quick facts

Lead sponsor	Universitaire Ziekenhuizen KU Leuven
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	301
Start date	1 June 2021
Primary completion	31 August 2023
Estimated completion	15 November 2023
Sites	8 locations across Belgium

Drugs / interventions tested

• Vitamin C — full drug profile →
• Normal saline

Conditions studied

• Sepsis — all drugs for Sepsis →
• Septic Shock — all drugs for Septic Shock →
• Sepsis, Severe — all drugs for Sepsis, Severe →

Sponsor

Universitaire Ziekenhuizen KU Leuven — full company profile →

Who can join

18 and older, any sex, with Sepsis or Septic Shock. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In this clinical trial the effect of early administration of Vitamin C is investigated in patients admitted at the emergency department with sepsis or septic shock.

When a patient has sepsis, his/her body is causing damage to its own tissues and organs as result of an infection. This can lead to septic shock. The patient has a low blood pressure, his/her organs stop working and the patient may even die.

The aim of this trial is to investigate the efficiency of Vitamin C in sepsis and septic shock. Vitamin C is a vitamin present in various foods and has been approved as dietary supplement by the Belgian authorities. Over the years it has been proven that Vitamin C is very safe. In addition, several studies have shown that Vitamin C can also have a protective effect. It can reduce organ damage and increase survival rates. Although several studies suggest that Vitamin C can help fight sepsis, it is not yet used in practice. This Belgian trial, in which several hospitals participate, hopes to provide a clear answer to the question: "Should Vitamin C be administered to patients admitted in an emergency department with sepsis or septic shock?"

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Ascorbic acid attenuates activation and cytokine production in sepsis-like monocytes.
   Schmidt T, Kahn R, Kahn F. · · 2022 · cited 12× · PMID 35141934 · DOI 10.1002/jlb.4ab0521-243r
2. Early administration of vitamin C in patients with sepsis or septic shock in emergency departments: a multicenter, double-blind, randomized controlled trial: the C-EASIE trial.
   Vandervelden S, Cortens B, Fieuws S, Eegdeman W, et al · · 2025 · cited 7× · PMID 40269974 · DOI 10.1186/s13054-025-05383-x
3. Early administration of Vitamin C in patients with sepsis or septic shock in emergency departments: A multicenter, double blinded, randomized controlled trial: The C-EASIE trial protocol.
   Vandervelden S, Wauters L, Breuls J, Fieuws S, et al · · 2021 · cited 5× · PMID 34739527 · DOI 10.1371/journal.pone.0259699
4. Vitamin C for septic shock in previous randomized trials: implications of erroneous dosing, timing, and duration.
   Lee HJ, Kim OH, Baek MS, Kim WY. · · 2022 · cited 3× · PMID 35292098 · DOI 10.1186/s13054-022-03946-w
5. Orange You Wishing There Were Definitive Randomized Controlled Trials Already?
   Hager DN, Agarwal A, Rochwerg B. · · 2021 · cited 1× · PMID 34793385 · DOI 10.1097/ccm.0000000000005319