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?"
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
301
IV
IV
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
Sequential Organ Failure Assessment (SOFA) score
Average post-baseline patient SOFA score, SOFA score range: 0-24, with 24 being the worst outcome (death)
Time frame: 5 days
28-day mortality
Time frame: 28 days
Maximum SOFA score
Maximum SOFA score measured during 5 intervention period. SOFA score ranging from 0 to 24, with 24 begin the worst outcome (death)
Time frame: 5 days
Length of hospital stay
Total length of hospital stay of the patient (including beyond intervention period)
Time frame: 3 months
Length of ICU stay
Total length of ICU stay of the patient (including beyond intervention period)
Time frame: 3 months
Duration Vasopressors
Total duration where vasopression is required (hours)
Time frame: 5 days
Dosage Vasopressors
Total dosage of Vasopressors required (mcg/kg/min)
Time frame: 5 days
need for Renal Replacement Therapy (RRT)
was RRT needed
Time frame: 5 days
duration of Renal Replacement Therapy (RRT)
total duration of RRT (hours)
Time frame: 5 days
Ventilator days
Total number of days the patient requires ventilator support (including beyond intervention period)
Time frame: 3 months
Steroids
Total dose of steroids given
Time frame: 5 days
Quality of life questionnaire (EQ-5D-5L)
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Time frame: 3 months
Time to return to work
Time to return to work of the patient after ED admission (in days)
Time frame: 3 months
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