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NCT03509350: VICTAS

Vitamin C, Thiamine, and Steroids in Sepsis

Completed Phase 3 Results posted Last updated 13 April 2021
What this trial tests

Phase 3 trial testing Vitamin C in Sepsis in 501 participants. Completed in 29 January 2020.

Timeline
22 August 2018
Primary endpoint
22 August 2019
29 January 2020

Quick facts

Lead sponsorEmory University
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposesupportive care
Enrollment501
Start date22 August 2018
Primary completion22 August 2019
Estimated completion29 January 2020
Sites43 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Emory University

Who can join

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

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Vasopressor and Ventilator-free Days (VVFD) Primary · Up to Day 30

The primary outcome measure is VVFD in the first 30 days after the start of treatment. The endpoint was recorded to the nearest day. Participants who died are scored zero days, even if there was a period during which the participant was alive and free of vasopressors and mechanical ventilation. Participants who must return to ventilation and/or vasopressors had their counters reset at zero days.

GroupValue95% CI
Treatment Protocol250 – 29
Control Protocol260 – 28
Mortality at 30 Days Secondary · Day 30

The number of participants who did not survive until Day 30 is compared between study arms.

GroupValue95% CI
Treatment Protocol56
Control Protocol60
Intensive Care Unit (ICU) Mortality Secondary · Day 30

The number of participants who died while in the ICU is compared between study arms.

GroupValue95% CI
Treatment Protocol52
Control Protocol49
Mortality at 180 Days Secondary · Day 180

The number of participants who did not survive until Day 180 is compared between study arms.

GroupValue95% CI
Treatment Protocol102
Control Protocol94
Length of ICU Stay Secondary · Day 30

The number of days that participants were in the ICU is compared between study arms.

GroupValue95% CI
Treatment Protocol6.7± 7.3
Control Protocol6.4± 6.9
Length of Hospital Stay Secondary · Day 30

The number of days that participants were in the hospital is compared between study arms.

GroupValue95% CI
Treatment Protocol12.6± 10
Control Protocol13.5± 25.7
Digit Span Test Score Secondary · Day 180

The Digit Span Test is used to assesses attention. In the Digit Span Test, participants are read a series of numbers and are asked to repeat them back in the same order. The Digit Span test is scored by the number of digits the participant is able to remember in each test. Higher scores indicate greater ability to pay attention and to remember sequences. The average adult can remember about 7 numbers, plus or minus two, without making an error.

GroupValue95% CI
Treatment Protocol8.3± 3.1
Control Protocol9.5± 3.8
Number of Participants With Delirium Assessed With the DeliriumTelephone Confusion Assessment Method (CAM) Secondary · Day 180

The Telephone CAM evaluates dementia with 9-items, where additional questions are asked if symptoms are present. Rather than providing a summary score, if participants exhibit signs of a change in mental status which fluctuates and they experience inattention, along with disorganized thinking or altered level of consciousness, delirium is suggested.

GroupValue95% CI
Treatment Protocol0
Control Protocol0
Hayling Test Score Secondary · Day 180

Executive function is assessed with the Hayling Test. The Hayling Test includes two parts of 15 items each where participants complete sentences by providing the missing word. The test is scored as the amount of time it takes, in seconds, to recite a correct response and the appropriateness of the response (in Part 2). Scaled scores range from 1 to 10 where 1 = impaired, 6 = average, and 10 = very superior.

GroupValue95% CI
Treatment Protocol4.2± 1.9
Control Protocol4.2± 1.8
Controlled Oral Word Association Test (COWAT) Score Secondary · Day 180

Language is assessed with the Controlled Oral Word Association Test (COWAT). Participants generate words beginning with selected letters within 60 seconds. Generating a higher number of words indicates greater language skills.

GroupValue95% CI
Treatment Protocol40± 11
Control Protocol40± 11
Wechsler Memory Scale III - Delayed Recall Logical Memory Score Secondary · Day 180

Memory is assessed with the Logical Memory subtest from the Wechsler Memory Scale III. Participants listened to two short paragraphs and were asked to recall details from each story after 30 minutes. Scores represent the number of correctly remembered details. Total scores range from 0 to 25 with higher scores reflecting better memory.

GroupValue95% CI
Treatment Protocol6.9± 2.8
Control Protocol8.1± 3.2
Telephone Interview for Cognitive Status (TICS) Secondary · Day 180

The Telephone Interview for Cognitive Status (TICS) is an 11-item instrument assessing orientation. Correct responses to the items are scored in a variety of ways, depending on how much of the response is correct. Total scores range from 0 to 41 with higher scores indicating increased cognitive orientation.

GroupValue95% CI
Treatment Protocol30.6± 4.9
Control Protocol31.2± 5.2

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events potentially associated with the study treatment and serious adverse events were monitored from the time of randomization up to Day 30. Mortality was recorded from the time of randomization up to Day 180.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment Protocol
Serious: 0/252 (0%)
Deaths: 102/252
Control Protocol
Serious: 0/249 (0%)
Deaths: 94/249
Other adverse events (2 terms — click to expand)

ReactionSystemTreatment ProtocolControl Protocol
Hemorrhagic shock due to hemolysisBlood and lymphatic system disorders
Worsening of renal functionRenal and urinary disorders

Data from ClinicalTrials.gov NCT03509350 adverse events section.

Sponsor's own description

The VItamin C, Thiamine And Steroids in Sepsis (VICTAS) Study is a double-blind, placebo-controlled, adaptive randomized clinical trial designed to investigate the efficacy of the combined use of vitamin C, thiamine and corticosteroids versus indistinguishable placebos for patients with sepsis. The objective of this study is to demonstrate the efficacy of combination therapy using vitamin C, thiamine and corticosteroids in reducing mortality and improving organ function in critically ill patients with sepsis.

Publications & conference data

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

  1. Effect of Vitamin C, Thiamine, and Hydrocortisone on Ventilator- and Vasopressor-Free Days in Patients With Sepsis: The VICTAS Randomized Clinical Trial.
    Sevransky JE, Rothman RE, Hager DN, Bernard GR, et al · · 2021 · cited 206× · PMID 33620405 · DOI 10.1001/jama.2020.24505
  2. 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
  3. 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
  4. 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
  5. Vitamin C: A Comprehensive Review of Its Role in Health, Disease Prevention, and Therapeutic Potential.
    Alberts A, Moldoveanu ET, Niculescu AG, Grumezescu AM. · · 2025 · cited 41× · PMID 39942850 · DOI 10.3390/molecules30030748
  6. Recent innovations in adaptive trial designs: A review of design opportunities in translational research.
    Kaizer AM, Belli HM, Ma Z, Nicklawsky AG, et al · · 2023 · cited 25× · PMID 37313381 · DOI 10.1017/cts.2023.537
  7. Association of Vitamin C, Thiamine, and Hydrocortisone Infusion With Long-term Cognitive, Psychological, and Functional Outcomes in Sepsis Survivors: A Secondary Analysis of the Vitamin C, Thiamine, and Steroids in Sepsis Randomized Clinical Trial.
    Williams Roberson S, Nwosu S, Collar EM, Kiehl AL, et al · · 2023 · cited 20× · PMID 36853612 · DOI 10.1001/jamanetworkopen.2023.0380
  8. Treating sepsis with vitamin C, thiamine, and hydrocortisone: Exploring the quest for the magic elixir.
    Obi J, Pastores SM, Ramanathan LV, Yang J, et al · · 2020 · cited 19× · PMID 32061462 · DOI 10.1016/j.jcrc.2019.12.011

Verify or expand the search:

Other trials of Vitamin C

Trials testing the same drug.

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