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

Phase 3

Completed

• Conditions: Sepsis, Severe; Septic Shock; Sepsis
• Interventions: Drug: Vitamin C; Drug: Normal saline

• Registration Number: NCT04747795
• Lead Sponsor: Universitaire Ziekenhuizen KU 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?"

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-04
• Study First Submitted QC: 2021-02-09
• Study First Posted: 2021-02-10
• Study Start: 2021-06-01
• Primary Completion: 2023-08-31
• Status Verified: 2023-09
• Study Completion: 2023-11-15
• Last Update Submitted: 2024-01-23
• Last Update Posted: 2024-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 301

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard care + Vitamin C	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.
standard care + placebo	Normal saline	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.

Primary Outcome Measures

Name	Time	Method
Sequential Organ Failure Assessment (SOFA) score	5 days	Average post-baseline patient SOFA score, SOFA score range: 0-24, with 24 being the worst outcome (death)

Secondary Outcome Measures

Name	Time	Method
need for Renal Replacement Therapy (RRT)	5 days	was RRT needed
duration of Renal Replacement Therapy (RRT)	5 days	total duration of RRT (hours)
28-day mortality	28 days
Maximum SOFA score	5 days	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	3 months	Total length of hospital stay of the patient (including beyond intervention period)
Dosage Vasopressors	5 days	Total dosage of Vasopressors required (mcg/kg/min)
Ventilator days	3 months	Total number of days the patient requires ventilator support (including beyond intervention period)
Time to return to work	3 months	Time to return to work of the patient after ED admission (in days)
Length of ICU stay	3 months	Total length of ICU stay of the patient (including beyond intervention period)
Duration Vasopressors	5 days	Total duration where vasopression is required (hours)
Steroids	5 days	Total dose of steroids given
Quality of life questionnaire (EQ-5D-5L)	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.

Trial Locations

Locations (8)

Algemeen Ziekenhuis Turnhout; 🇧🇪 Turnhout, Belgium

Centre Hospitalier Universitaire Saint-Pierre Bruxelles; 🇧🇪 Brussels, Belgium

Université Libre de Bruxelles Erasme; 🇧🇪 Brussels, Belgium

Universitair Ziekenhuis Antwerpen; 🇧🇪 Antwerp, Belgium

Universitair Ziekenhuis Brussel; 🇧🇪 Brussels, Belgium

GasthuisZusters Antwerpen; 🇧🇪 Antwerp, Belgium

Universitaire Ziekenhuizen Leuven; 🇧🇪 Leuven, Belgium

Centre Hospitalier Universitaire de Liège; 🇧🇪 Liège, Belgium