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

• Status: Recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

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?"

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitaire Ziekenhuizen Leuven
• Collaborator: Federaal Kenniscentrum voor Gezondheidszorg, Belgium
• Treatments: Ascorbic Acid

Criteria

Inclusion Criteria:

• Patient has a 'suspected infection': this requires the combination of antibiotic administration and body fluid cultures within the first 6 hours after Emergency Department presentation.

• Patient has a NEWS score ≥ 5.

Exclusion Criteria:

• Patient (≥18 years old) or legally authorized representative didn't provide informed consent. Delayed informed consent can be applied in cases where the patient is critically ill and no LAR is available.

• antibiotic administration as a single dose or as a prophylactic treatment.

• antibiotics administered without an accompanying body fluid culture according to the timeframe (within 6 hours after emergency department presentation).

• 'Do no intubate' or 'comfort measures only' status.

• Failure to randomize within 6 hours after Emergency Department presentation.

• Weight < 45 kg.

• Pregnant or breastfeeding.

• Known allergy for Vitamin C.

• Known history of oxalate nephropathy or hyperoxaluria.

• Known history of glucose-6-phosphate dehydrogenase deficiency.

• Known history of chronic iron overload due to iron storage and other diseases.

• The patient is already on IV steroids for a reason other than septic shock.

• Proven active COVID-19 infection (positive swab and/or CT scan positive for COVID-19 within 14 days prior to or at ED presentation).

• Participation in an interventional trial with an investigational medicinal product (IMP) or device