Vitamin C
DrugIV
Other names: Ascorbic Acid
NCT Number: NCT04747795
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?"
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Notify Me18 year and older
All sexes
Interventional
Phase 3
GasthuisZusters Antwerpen, Antwerp, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
IV
Other names: Ascorbic Acid
IV
Other names: physiological serum, placebo
Time frame: 5 days
Average post-baseline patient SOFA score, SOFA score range: 0-24, with 24 being the worst outcome (death)
Time frame: 28 days
Time frame: 5 days
Maximum SOFA score measured during 5 intervention period. SOFA score ranging from 0 to 24, with 24 begin the worst outcome (death)
Time frame: 3 months
Total length of hospital stay of the patient (including beyond intervention period)
Time frame: 3 months
Total length of ICU stay of the patient (including beyond intervention period)
Time frame: 5 days
Total duration where vasopression is required (hours)
Time frame: 5 days
Total dosage of Vasopressors required (mcg/kg/min)
Time frame: 5 days
was RRT needed
Time frame: 5 days
total duration of RRT (hours)
Time frame: 3 months
Total number of days the patient requires ventilator support (including beyond intervention period)
Time frame: 5 days
Total dose of steroids given
Time frame: 3 months
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 of the patient after ED admission (in days)
Universitaire Ziekenhuizen KU Leuven
Other
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
Acronym: c-easie
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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