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Trial record 1 of 2 for:    vitamin c | Sepsis | Belgium
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Early Administration of Vitamin C in Patients With Sepsis or Septic Shock in Emergency Departments (c-easie)

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ClinicalTrials.gov Identifier: NCT04747795
Recruitment Status : Not yet recruiting
First Posted : February 10, 2021
Last Update Posted : February 10, 2021
Sponsor:
Collaborator:
Federaal Kenniscentrum voor Gezondheidszorg, Belgium
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief 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. 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?"


Condition or disease Intervention/treatment Phase
Sepsis Septic Shock Sepsis, Severe Drug: Vitamin C Drug: Normal saline Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : October 5, 2022
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: standard care + placebo
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.
Drug: Normal saline
IV
Other Names:
  • physiological serum
  • placebo

Active Comparator: standard care + Vitamin C
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.
Drug: Vitamin C
IV
Other Name: Ascorbic Acid




Primary Outcome Measures :
  1. Sequential Organ Failure Assessment (SOFA) score [ Time Frame: 5 days ]
    Average post-baseline patient SOFA score, SOFA score range: 0-24, with 24 being the worst outcome (death)


Secondary Outcome Measures :
  1. 28-day mortality [ Time Frame: 28 days ]
  2. Maximum SOFA score [ 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)

  3. Length of hospital stay [ Time Frame: 3 months ]
    Total length of hospital stay of the patient (including beyond intervention period)

  4. Length of ICU stay [ Time Frame: 3 months ]
    Total length of ICU stay of the patient (including beyond intervention period)

  5. Duration Vasopressors [ Time Frame: 5 days ]
    Total duration where vasopression is required (hours)

  6. Dosage Vasopressors [ Time Frame: 5 days ]
    Total dosage of Vasopressors required (mcg/kg/min)

  7. need for Renal Replacement Therapy (RRT) [ Time Frame: 5 days ]
    was RRT needed

  8. duration of Renal Replacement Therapy (RRT) [ Time Frame: 5 days ]
    total duration of RRT (hours)

  9. Ventilator days [ Time Frame: 3 months ]
    Total number of days the patient requires ventilator support (including beyond intervention period)

  10. Steroids [ Time Frame: 5 days ]
    Total dose of steroids given

  11. Quality of life questionnaire (EQ-5D-5L) [ 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.


  12. Time to return to work [ Time Frame: 3 months ]
    Time to return to work of the patient after ED admission (in days)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04747795


Contacts
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Contact: Lina Wauters, PhD +3216345820 lina.wauters@uzleuven.be
Contact: Stefanie Vandervelden, MD +3216 345405 stefanie.vandervelden@uzleuven.be

Locations
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Belgium
GasthuisZusters Antwerpen
Antwerp, Belgium
Contact: Philippe Vanhove, MD    +3234435262    philippe.vanhove@gza.be   
Contact: Brecht De Tavernier       brecht.detavernier@gza.be   
Universitair Ziekenhuis Antwerpen
Antwerp, Belgium
Contact: Koen Monsieurs, MD    +3238214607    koen.monsieurs@uza.be   
Contact: Ken Dewitte, MD       ken.dewitte@uza.be   
Centre Hospitalier Universitaire Saint-Pierre Bruxelles
Brussels, Belgium
Contact: Magali Bartiaux, MD    +3225355037    magali.bartiaux@stpierre-bru.be   
Contact: Katty Renard       katty.renard@stpierre-bru.be   
Universitair Ziekenhuis Brussel
Brussels, Belgium
Contact: Ives Hubloue, MD    +322477 51 53    ives.hubloue@uzbrussel.be   
Contact: Evert Verhoeven, MD       evert.verhoeven@uzbrussel.be   
Université Libre de Bruxelles Erasme
Brussels, Belgium
Contact: Jacques Creteur, MD    +322 555 44 54    jacques.creteur@erasme.ulb.ac.be   
Contact: Dominique Durand       ddurand@ulb.ac.be   
Universitaire Ziekenhuizen Leuven
Leuven, Belgium
Contact: Didier Desruelles, MD    +3216 344638    didier.desruelles@uzleuven.be   
Contact: Stefanie Vandervelden, MD    +3216 345405    stefanie.vandervelden@uzleuven.be   
Centre Hospitalier Universitaire de Liège
Liège, Belgium
Contact: François Stifkens, MD    +3242843505    fstifkens@chuliege.be   
Contact: Meryl Paquay       Meryl.Hajaoui@uliege.be   
Algemeen Ziekenhuis Turnhout
Turnhout, Belgium
Contact: Jan Breuls, MD    +3214407055    jan.breuls@azturnhout.be   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Federaal Kenniscentrum voor Gezondheidszorg, Belgium
Investigators
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Principal Investigator: Didier Desruelles, MD Universitaire Ziekenhuizen Leuven
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT04747795    
Other Study ID Numbers: S63213
2020-001862-12 ( EudraCT Number )
KCE 19-1237 ( Other Grant/Funding Number: Federaal kenniscentrum voor de gezondheidszorg (KCE) )
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universitaire Ziekenhuizen Leuven:
Vitamin C
ascorbic acid
sepsis
septic shock
RCT
Additional relevant MeSH terms:
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Sepsis
Toxemia
Ascorbic Acid
Vitamins
Shock, Septic
Emergencies
Shock
Disease Attributes
Pathologic Processes
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents