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Early Administration of Vitamin C in Patients With Sepsis or Septic Shock in Emergency Departments (c-easie)

Primary Purpose

Sepsis, Septic Shock, Sepsis, Severe

Status
Active
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
Vitamin C
Normal saline
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis focused on measuring Vitamin C, ascorbic acid, sepsis, septic shock, RCT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • GasthuisZusters Antwerpen
  • Universitair Ziekenhuis Antwerpen
  • Centre Hospitalier Universitaire Saint-Pierre Bruxelles
  • Universitair Ziekenhuis Brussel
  • Université Libre de Bruxelles Erasme
  • Universitaire Ziekenhuizen Leuven
  • Centre Hospitalier Universitaire de Liège
  • Algemeen Ziekenhuis Turnhout

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

standard care + placebo

standard care + Vitamin C

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

28-day mortality
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)
Length of hospital stay
Total length of hospital stay of the patient (including beyond intervention period)
Length of ICU stay
Total length of ICU stay of the patient (including beyond intervention period)
Duration Vasopressors
Total duration where vasopression is required (hours)
Dosage Vasopressors
Total dosage of Vasopressors required (mcg/kg/min)
need for Renal Replacement Therapy (RRT)
was RRT needed
duration of Renal Replacement Therapy (RRT)
total duration of RRT (hours)
Ventilator days
Total number of days the patient requires ventilator support (including beyond intervention period)
Steroids
Total dose of steroids given
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 to return to work
Time to return to work of the patient after ED admission (in days)

Full Information

First Posted
February 4, 2021
Last Updated
September 28, 2023
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Federaal Kenniscentrum voor Gezondheidszorg, Belgium
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1. Study Identification

Unique Protocol Identification Number
NCT04747795
Brief Title
Early Administration of Vitamin C in Patients With Sepsis or Septic Shock in Emergency Departments
Acronym
c-easie
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
August 31, 2023 (Actual)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Federaal Kenniscentrum voor Gezondheidszorg, Belgium

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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?"

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Septic Shock, Sepsis, Severe
Keywords
Vitamin C, ascorbic acid, sepsis, septic shock, RCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
301 (Actual)

8. Arms, Groups, and Interventions

Arm Title
standard care + placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
standard care + Vitamin C
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Vitamin C
Other Intervention Name(s)
Ascorbic Acid
Intervention Description
IV
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
physiological serum, placebo
Intervention Description
IV
Primary Outcome Measure Information:
Title
Sequential Organ Failure Assessment (SOFA) score
Description
Average post-baseline patient SOFA score, SOFA score range: 0-24, with 24 being the worst outcome (death)
Time Frame
5 days
Secondary Outcome Measure Information:
Title
28-day mortality
Time Frame
28 days
Title
Maximum SOFA score
Description
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
Title
Length of hospital stay
Description
Total length of hospital stay of the patient (including beyond intervention period)
Time Frame
3 months
Title
Length of ICU stay
Description
Total length of ICU stay of the patient (including beyond intervention period)
Time Frame
3 months
Title
Duration Vasopressors
Description
Total duration where vasopression is required (hours)
Time Frame
5 days
Title
Dosage Vasopressors
Description
Total dosage of Vasopressors required (mcg/kg/min)
Time Frame
5 days
Title
need for Renal Replacement Therapy (RRT)
Description
was RRT needed
Time Frame
5 days
Title
duration of Renal Replacement Therapy (RRT)
Description
total duration of RRT (hours)
Time Frame
5 days
Title
Ventilator days
Description
Total number of days the patient requires ventilator support (including beyond intervention period)
Time Frame
3 months
Title
Steroids
Description
Total dose of steroids given
Time Frame
5 days
Title
Quality of life questionnaire (EQ-5D-5L)
Description
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
Title
Time to return to work
Description
Time to return to work of the patient after ED admission (in days)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Didier Desruelles, MD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
GasthuisZusters Antwerpen
City
Antwerp
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen
City
Antwerp
Country
Belgium
Facility Name
Centre Hospitalier Universitaire Saint-Pierre Bruxelles
City
Brussels
Country
Belgium
Facility Name
Universitair Ziekenhuis Brussel
City
Brussels
Country
Belgium
Facility Name
Université Libre de Bruxelles Erasme
City
Brussels
Country
Belgium
Facility Name
Universitaire Ziekenhuizen Leuven
City
Leuven
Country
Belgium
Facility Name
Centre Hospitalier Universitaire de Liège
City
Liège
Country
Belgium
Facility Name
Algemeen Ziekenhuis Turnhout
City
Turnhout
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34739527
Citation
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.
Results Reference
derived

Learn more about this trial

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

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