C-EASIE trial: Vitamin C - Early Administration in Sepsis In the EmergencyDepartment

Phase 1

• Conditions: We will investigate the potential benefit of early administration of highdoses of Vitamin C in addition to standard care in patients with sepsis orseptic shock.; MedDRA version: 20.0Level: PTClassification code 10040047Term: SepsisSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 23.1Level: PTClassification code 10040070Term: Septic shockSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2020-001862-12-BE
• Lead Sponsor: niversity Hospitals Leuven, Clinical Trial Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-17
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Participants eligible for inclusion in this trial must meet all of the
following criteria:
1. Patient is = 18 years old.
2. Patient has a 'suspected infection': this requires the combination of AB administration and body fluid cultures within the first 6 hours after ED presentation.
3. NEWS score = 5.

NEWS is based on a simple aggregate scoring system in which a score is allocated to physiological measurements, already recorded in routine practice, when patients present to the hospital. Six simple physiological parameters form the basis of the scoring system: respiration rate, oxygen saturation, systolic blood pressure, pulse rate, level of consciousness or new confusion and temperature.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

Participants eligible for this trial must not meet any of the following criteria:
1. Patient (=18 years old) or legally authorized representative (LAR) didn't provide informed consent. Delayed informed consent can be applied in cases where the patient is critically ill and no LAR is available
2. AB administration as a single dose or as a prophylactic treatment.
3. AB administered without an accompanying body fluid culture according to the timeframe (within 6 hours after ED presentation).
4. 'Do no intubate' or 'comfort measures only' status.
5. Failure to randomize within 6 hours.
6. Weight < 45 kg.
7. Pregnant or breastfeeding.
8. Allergy for Vitamin C.
9. Known history of oxalate nephropathy or hyperoxaluria.
10. Known history of glucose-6-phosphate dehydrogenase deficiency.
11. Known history of chronic iron overload due to iron storage and other diseases.
12. The patient is already on IV steroids for a reason other than septic shock.
13. Proven active COVID-19 infection (positive swab and/or CT scan positive for COVID).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified