Clinical trial NCT04747795: Early Administration of Vitamin C in Patients With Sepsis or Septic Shock in Emergency Departments
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sepsis
Septic Shock
Sepsis, Severe
Keywords: Vitamin C
ascorbic acid
sepsis
septic shock
RCT
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Federaal Kenniscentrum voor Gezondheidszorg, Belgium
First posted: 2021-02-10
Enrollment: 301
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?"


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

Primary outcomes:
measure: Sequential Organ Failure Assessment (SOFA) score
timeFrame: 5 days
Secondary outcomes:
measure: 28-day mortality
timeFrame: 28 days
measure: Maximum SOFA score
timeFrame: 5 days
measure: Length of hospital stay
timeFrame: 3 months
measure: Length of ICU stay
timeFrame: 3 months
measure: Duration Vasopressors
timeFrame: 5 days
measure: Dosage Vasopressors
timeFrame: 5 days
measure: need for Renal Replacement Therapy (RRT)
timeFrame: 5 days
measure: duration of Renal Replacement Therapy (RRT)
timeFrame: 5 days
measure: Ventilator days
timeFrame: 3 months
measure: Steroids
timeFrame: 5 days
measure: Quality of life questionnaire (EQ-5D-5L)
timeFrame: 3 months
measure: Time to return to work
timeFrame: 3 months
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: GasthuisZusters Antwerpen
city: Antwerp
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Brussels
country: Belgium
facility: Centre Hospitalier Universitaire Saint-Pierre Bruxelles
city: Brussels
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Brussels
country: Belgium
facility: Université Libre de Bruxelles Erasme
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liège
city: Turnhout
country: Belgium
facility: Algemeen Ziekenhuis Turnhout
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Didier Desruelles, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.