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NCT03335124

The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock

Terminated Phase 4 Last updated 19 February 2019
What this trial tests

Phase 4 trial testing Vitamin C in Sepsis in 5 participants. Terminated before completion.

Timeline
26 September 2017
Primary endpoint
1 December 2018
1 December 2018

Quick facts

Lead sponsorUniversity Medical Centre Ljubljana
PhasePhase 4
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment5
Start date26 September 2017
Primary completion1 December 2018
Estimated completion1 December 2018
Sites1 location across Slovenia

Drugs / interventions tested

Conditions studied

Sponsor

University Medical Centre Ljubljana

Who can join

18 and older, any sex, with Sepsis or Septic Shock. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The global burden of sepsis is substantial with an estimated 15 to 19 million cases per year; the vast majority of these cases occur in low income countries. New therapeutic approaches to sepsis are desperately required; considering the global burden of sepsis these interventions should be effective, cheap, safe and readily available. The aim is to study the synergistic effect of vitamin C, hydrocortisone and thiamine on survival in patients with severe sepsis and septic shock.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Ascorbic acid, corticosteroids, and thiamine in sepsis: a review of the biologic rationale and the present state of clinical evaluation.
    Moskowitz A, Andersen LW, Huang DT, Berg KM, et al · · 2018 · cited 91× · PMID 30373647 · DOI 10.1186/s13054-018-2217-4
  2. Corticosteroids for treating sepsis in children and adults.
    Annane D, Bellissant E, Bollaert PE, Briegel J, et al · · 2019 · cited 76× · PMID 31808551 · DOI 10.1002/14651858.cd002243.pub4
  3. The Vitamin C, Thiamine and Steroids in Sepsis (VICTAS) Protocol: a prospective, multi-center, double-blind, adaptive sample size, randomized, placebo-controlled, clinical trial.
    Hager DN, Hooper MH, Bernard GR, Busse LW, et al · · 2019 · cited 47× · PMID 30953543 · DOI 10.1186/s13063-019-3254-2
  4. Doctor-your septic patients have scurvy!
    Marik PE, Hooper MH. · · 2018 · cited 26× · PMID 29378661 · DOI 10.1186/s13054-018-1950-z
  5. Steroids for sepsis: yes, no or maybe.
    Marik PE. · · 2018 · cited 12× · PMID 29849191 · DOI 10.21037/jtd.2018.04.35
  6. Corticosteroids for treating sepsis in children and adults.
    Annane D, Briegel J, Granton D, Bellissant E, et al · · 2025 · cited 7× · PMID 40470636 · DOI 10.1002/14651858.cd002243.pub5

Verify or expand the search:

Other trials of Vitamin C

Trials testing the same drug.

Other recruiting trials for Sepsis

Currently open trials in the same condition.

Other University Medical Centre Ljubljana trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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