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SepsisPhase 3c-easieNCT04747795

Early Administration of Vitamin C in Patients With Sepsis or Septic Shock in Emergency Departments

A Phase 3 study testing Vitamin C and Normal saline in people with Sepsis and Septic Shock, run by Universitaire Ziekenhuizen KU Leuven at 8 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sepsis, Septic Shock, Sepsis, Severe
What is being tested?
Vitamin C and Normal saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
301 participants
Where
8 sitesBelgium
Study dates
1 Jun 2021to 15 Nov 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Belgium8 sites

  • GasthuisZusters Antwerpen

    Antwerp

  • Universitair Ziekenhuis Antwerpen

    Antwerp

  • Centre Hospitalier Universitaire Saint-Pierre Bruxelles

    Brussels

  • Universitair Ziekenhuis Brussel

    Brussels

  • Université Libre de Bruxelles Erasme

    Brussels

  • Universitaire Ziekenhuizen Leuven

    Leuven

  • Centre Hospitalier Universitaire de Liège

    Liège

  • Algemeen Ziekenhuis Turnhout

    Turnhout

Other trials in Belgium

About this study

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

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?"

Being tested
Vitamin C, Normal saline
Keywords
Vitamin C, ascorbic acid, sepsis, septic shock, RCT
Medical subject headings
Sepsis, Shock, Septic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin CDrug

    Also called Ascorbic Acid

    IV

  • Normal salineDrug

    Also called physiological serum, placebo

    IV

Study groups in NCT04747795
Study groupRoleWhat they receive
standard care + placeboPlacebo comparatorThe '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.
Receives: Drug: Normal saline
standard care + Vitamin CActive comparatorThe '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.
Receives: Drug: Vitamin C

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sequential Organ Failure Assessment (SOFA) score

    Average post-baseline patient SOFA score, SOFA score range: 0-24, with 24 being the worst outcome (death)

    Measured: 5 days

Secondary outcomes (12)

  1. 28-day mortality

    Measured: 28 days

  2. 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)

    Measured: 5 days

  3. Length of hospital stay

    Total length of hospital stay of the patient (including beyond intervention period)

    Measured: 3 months

  4. Length of ICU stay

    Total length of ICU stay of the patient (including beyond intervention period)

    Measured: 3 months

  5. Duration Vasopressors

    Total duration where vasopression is required (hours)

    Measured: 5 days

  6. Dosage Vasopressors

    Total dosage of Vasopressors required (mcg/kg/min)

    Measured: 5 days

  7. need for Renal Replacement Therapy (RRT)

    was RRT needed

    Measured: 5 days

  8. duration of Renal Replacement Therapy (RRT)

    total duration of RRT (hours)

    Measured: 5 days

  9. Ventilator days

    Total number of days the patient requires ventilator support (including beyond intervention period)

    Measured: 3 months

  10. Steroids

    Total dose of steroids given

    Measured: 5 days

  11. 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.

    Measured: 3 months

  12. Time to return to work

    Time to return to work of the patient after ED admission (in days)

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2021
  2. Study start1 Jun 2021
  3. Primary completion31 Aug 2023
  4. Study completion15 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
301 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04747795
Sponsor's protocol ID
S63213
Other IDs
2020-001862-12, KCE 19-1237
Acronym
c-easie
Status last verified
Sep 2023
First submitted
4 Feb 2021
Last updated
25 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40269974

  • 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.

    PubMed 34739527

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vitamin C and Normal saline in people with Sepsis and Septic Shock, run by Universitaire Ziekenhuizen KU Leuven at 8 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sequential Organ Failure Assessment (SOFA) score (time frame: 5 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04747795, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.

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