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

Sepsis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04747795
• Other study ID #: S63213
• Secondary ID: 2020-001862-12KC
• Status: Completed
• Phase: Phase 3
• Start date: June 1, 2021
• Est. completion date: November 15, 2023

Study information

• Verified date: September 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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?"

Recruitment information / eligibility

• Status: Completed
• Enrollment: 301
• Est. completion date: November 15, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Sepsis
• Sepsis, Severe
• Septic Shock
• Shock
• Shock, Septic
• Toxemia

Intervention

Drug:
• Vitamin C
IV
• Normal saline
IV

Locations

Country	Name	City	State
Belgium	GasthuisZusters Antwerpen	Antwerp
Belgium	Universitair Ziekenhuis Antwerpen	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

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	Federaal Kenniscentrum voor Gezondheidszorg, Belgium

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	28-day mortality		28 days
Secondary	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
Secondary	Length of hospital stay	Total length of hospital stay of the patient (including beyond intervention period)	3 months
Secondary	Length of ICU stay	Total length of ICU stay of the patient (including beyond intervention period)	3 months
Secondary	Duration Vasopressors	Total duration where vasopression is required (hours)	5 days
Secondary	Dosage Vasopressors	Total dosage of Vasopressors required (mcg/kg/min)	5 days
Secondary	need for Renal Replacement Therapy (RRT)	was RRT needed	5 days
Secondary	duration of Renal Replacement Therapy (RRT)	total duration of RRT (hours)	5 days
Secondary	Ventilator days	Total number of days the patient requires ventilator support (including beyond intervention period)	3 months
Secondary	Steroids	Total dose of steroids given	5 days
Secondary	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
Secondary	Time to return to work	Time to return to work of the patient after ED admission (in days)	3 months