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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001862-12 | EudraCT Number | ||
| KCE 19-1237 | Other Grant/Funding Number | Federaal kenniscentrum voor de gezondheidszorg (KCE) |
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| Name | Class |
|---|---|
| Federaal Kenniscentrum voor Gezondheidszorg, Belgium | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard care + placebo | Placebo Comparator | 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. |
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| standard care + Vitamin C | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin C | Drug | IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Sequential Organ Failure Assessment (SOFA) score | Average post-baseline patient SOFA score, SOFA score range: 0-24, with 24 being the worst outcome (death) | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| 28-day mortality | 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) | 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Didier Desruelles, MD | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GasthuisZusters Antwerpen | Antwerp | Belgium | ||||
| Universitair Ziekenhuis Antwerpen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40269974 | Derived | 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. | |
| 34739527 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 14, 2024 | |
| Reset | Jan 3, 2025 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 23, 2023 | Jan 21, 2024 | SAP_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 14, 2024 | Jan 3, 2025 |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Normal saline | Drug | IV |
|
|
| Length of hospital stay | Total length of hospital stay of the patient (including beyond intervention period) | 3 months |
| Length of ICU stay | Total length of ICU stay of the patient (including beyond intervention period) | 3 months |
| Duration Vasopressors | Total duration where vasopression is required (hours) | 5 days |
| Dosage Vasopressors | Total dosage of Vasopressors required (mcg/kg/min) | 5 days |
| need for Renal Replacement Therapy (RRT) | was RRT needed | 5 days |
| duration of Renal Replacement Therapy (RRT) | total duration of RRT (hours) | 5 days |
| Ventilator days | Total number of days the patient requires ventilator support (including beyond intervention period) | 3 months |
| Steroids | Total dose of steroids given | 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. | 3 months |
| Time to return to work | Time to return to work of the patient after ED admission (in days) | 3 months |
| 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 |
| Derived |
| 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |