NCT04747795

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

Early Administration of Vitamin C in Patients With Sepsis or Septic Shock in Emergency Departments: a Multicentre, Double Blinded, Randomized Controlled Trial: the C-EASIE Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 301 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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?"

Conditions

• Sepsis
• Septic Shock
• Sepsis, Severe

Interventions

Type	Name	Description
DRUG	Vitamin C	IV
DRUG	Normal saline	IV

Timeline

• Start date: 2021-06-01
• Primary completion: 2023-08-31
• Completion: 2023-11-15
• First posted: 2021-02-10
• Last updated: 2024-01-25

Locations

8 sites across 1 country: Belgium