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

NCT04747795 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 301

Last updated 2024-01-25

No results posted yet for this study

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

DRUG

Vitamin C

IV

DRUG

Normal saline

IV

Sponsors & Collaborators

  • Federaal Kenniscentrum voor Gezondheidszorg, Belgium

    collaborator UNKNOWN

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Didier Desruelles, MD · Universitaire Ziekenhuizen KU Leuven

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2023-08-31
Completion
2023-11-15

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04747795 on ClinicalTrials.gov