Early Administration of Vitamin C in Patients With Sepsis or Septic Shock in Emergency Departments (c-easie)
Sepsis, Septic Shock, Sepsis, Severe
About this trial
This is an interventional treatment trial for Sepsis focused on measuring Vitamin C, ascorbic acid, sepsis, septic shock, RCT
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
Sites / Locations
- GasthuisZusters Antwerpen
- Universitair Ziekenhuis Antwerpen
- Centre Hospitalier Universitaire Saint-Pierre Bruxelles
- Universitair Ziekenhuis Brussel
- Université Libre de Bruxelles Erasme
- Universitaire Ziekenhuizen Leuven
- Centre Hospitalier Universitaire de Liège
- Algemeen Ziekenhuis Turnhout
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
standard care + placebo
standard care + Vitamin C
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.
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.