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

NCT ID: NCT04747795

Last Updated: 2024-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 301 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2023-11-15

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

standard care + placebo

The 'standard care' group will receive intermittent infusion of normal saline (3 ampoules of 5 ml 9mg/ml normal saline diluted in 50 ml of normal saline, every 6 hours) during 4 days or until hospital discharge and is started within 6 hours after presentation (time of triage) in the ED.

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

IV

standard care + Vitamin C

The 'standard care + Vitamin C' group will receive intermittent infusion of Vitamin C (3 ampoules of 500 mg/5ml Vitamin C diluted in 50 ml of normal saline, every 6 hours) during 4 days or until hospital discharge and is started within 6 hours after presentation (time of triage) in the ED.

Group Type: ACTIVE_COMPARATOR

Vitamin C

Intervention Type: DRUG

IV

Interventions

Vitamin C

IV

Intervention Type: DRUG

Normal saline

IV

Intervention Type: DRUG

Other Intervention Names

Ascorbic Acid; physiological serum; placebo

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federaal Kenniscentrum voor Gezondheidszorg, Belgium

UNKNOWN

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Didier Desruelles, MD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

GasthuisZusters Antwerpen

Antwerp, , Belgium

Universitair Ziekenhuis Antwerpen

Antwerp, , Belgium

Centre Hospitalier Universitaire Saint-Pierre Bruxelles

Brussels, , Belgium

Universitair Ziekenhuis Brussel

Brussels, , Belgium

Université Libre de Bruxelles Erasme

Brussels, , Belgium

Universitaire Ziekenhuizen Leuven

Leuven, , Belgium

Centre Hospitalier Universitaire de Liège

Liège, , Belgium

Algemeen Ziekenhuis Turnhout

Turnhout, , Belgium

Countries

Belgium

References

Vandervelden S, Cortens B, Fieuws S, Eegdeman W, Malinverni S, Vanhove P, Monsieurs K, Breuls J, Hubloue I, Stifkens F, Creteur J, Wauters L, Desruelles D; C-EASIE investigators. 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. Crit Care. 2025 Apr 23;29(1):160. doi: 10.1186/s13054-025-05383-x.

Reference Type: DERIVED

PMID: 40269974 (View on PubMed)

Vandervelden S, Wauters L, Breuls J, Fieuws S, Vanhove P, Hubloue I, Bartiaux M, Creteur J, Stifkens F, Monsieurs K, Desruelles D. 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. PLoS One. 2021 Nov 5;16(11):e0259699. doi: 10.1371/journal.pone.0259699. eCollection 2021.

Reference Type: DERIVED

PMID: 34739527 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2020-001862-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

KCE 19-1237

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

S63213

Identifier Type: -

Identifier Source: org_study_id