Status:
COMPLETED
Early Administration of Vitamin C in Patients With Sepsis or Septic Shock in Emergency Departments
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
Federaal Kenniscentrum voor Gezondheidszorg, Belgium
Conditions:
Sepsis
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2023
Estimated Enrollment :
301 Patients enrolled
Trial Details
Trial ID
NCT04747795
Start Date
June 1 2021
End Date
November 15 2023
Last Update
January 25 2024
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
GasthuisZusters Antwerpen
Antwerp, Belgium
2
Universitair Ziekenhuis Antwerpen
Antwerp, Belgium
3
Centre Hospitalier Universitaire Saint-Pierre Bruxelles
Brussels, Belgium
4
Universitair Ziekenhuis Brussel
Brussels, Belgium