Phase 3
Completed N=501
Vitamin C, Thiamine, and Steroids in Sepsis
Source: ClinicalTrials.gov NCT03509350 ↗Enrolled (actual)
501
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcomePrimary: Vasopressor and Ventilator-free Days (VVFD) — 25; 26 days
◆ Published Evidence
Highly cited
274citations · ~55 / year
Effect of Vitamin C, Thiamine, and Hydrocortisone on Ventilator- and Vasopressor-Free Days in Patients With Sepsis: The VICTAS Randomized Clinical Trial.
Summary
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.
Linked Publications (5)
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Effect of Vitamin C, Thiamine, and Hydrocortisone on Ventilator- and Vasopressor-Free Days in Patients With Sepsis: The VICTAS Randomized Clinical Trial.
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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.
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Update to the Vitamin C, Thiamine and Steroids in Sepsis (VICTAS) protocol: statistical analysis plan for a prospective, multicenter, double-blind, adaptive sample size, randomized, placebo-controlled, clinical trial.
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In response: Letter on update to the Vitamin C, Thiamine and Steroids in Sepsis (VICTAS) protocol.
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Surviving sepsis and intensive care unit delirium: a remarkable recovery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Vasopressor and Ventilator-free Days (VVFD) |
25; 26 | — |
| SECONDARY Mortality at 30 Days |
56; 60 | — |
| SECONDARY Intensive Care Unit (ICU) Mortality |
52; 49 | — |
| SECONDARY Mortality at 180 Days |
102; 94 | — |
| SECONDARY Length of ICU Stay |
6.7; 6.4 | — |
| SECONDARY Length of Hospital Stay |
12.6; 13.5 | — |
| SECONDARY Digit Span Test Score |
8.3; 9.5 | — |
| SECONDARY Number of Participants With Delirium Assessed With the DeliriumTelephone Confusion Assessment Method (CAM) |
0; 0 | — |
| SECONDARY Hayling Test Score |
4.2; 4.2 | — |
| SECONDARY Controlled Oral Word Association Test (COWAT) Score |
40; 40 | — |
| SECONDARY Wechsler Memory Scale III - Delayed Recall Logical Memory Score |
6.9; 8.1 | — |
| SECONDARY Telephone Interview for Cognitive Status (TICS) |
30.6; 31.2 | — |
| SECONDARY Wechsler Adult Intelligence Scale (WAIS)-IV Similarities Score |
7.7; 8.2 | — |
| SECONDARY Katz Index of Independence in Activities of Daily Living (ADL) Score |
2.8; 2.4 | — |
| SECONDARY Number of Participants Employed |
17; 25 | — |
| SECONDARY Functional Activities Questionnaire (FAQ) Score |
9.5; 7.7 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 6 |
11.9; 11.9 | — |
| SECONDARY Posttraumatic Stress Disorder-8 (PTSD-8) Score |
5.7; 5.2 | — |
| SECONDARY EuroQol, 5 Dimension (EQ-5D) Visual Analog Scale Score |
66; 67 | — |
Eligibility Criteria
Inclusion Criteria
- Suspected or confirmed infection as evidenced by ordering of blood cultures and administration of at least one antimicrobial agent
- Anticipated or confirmed intensive care unit (ICU) admission
- Acute respiratory or cardiovascular organ dysfunction attributed to sepsis as evidenced by at least one of the following requirements:
- Vasopressor Requirement - Continuous infusion of norepinephrine, epinephrine, vasopressin, dopamine, phenylephrine or other vasopressor agents at any dose for greater than 1 hour and required to maintain a mean arterial pressure ≥ 65 mm Hg despite intravenous crystalloid infusion of at least 1000cc
- Respiratory Support Requirement - Acute hypoxemic respiratory failure defined as persistent hypoxemia (partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) ≤ 300 or blood oxygen saturation (SpO2)/FiO2 ≤ 315) requiring (1) intubation and mechanical ventilation, or (2) positive pressure ventilation via tight-fitting face mask (i.e. continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP) or (3) high flow nasal cannula ≥ 40 liter per minute (LPM) flow and FiO2 ≥ 0.40
Exclusion Criteria
- Weight 24 hours before the subject could be randomized
- Limitations of care (defined as refusal of cardiovascular and respiratory support modes) including "do not intubate" (DNI) status
- Current hospitalization > 30 days at time of randomization
- Chronic hypoxemia requiring supplemental non-invasive oxygen (nasal cannula or NIPPV) or home mechanical ventilation
- Chronic cardiovascular failure requiring home mechanical hemodynamic support (e.g., LVAD) or home chemical hemodynamic support (e.g., milrinone)
- Known allergy or contraindication to vitamin C, thiamine, and/or corticosteroids (including previously or currently diagnosed primary hyperoxaluria and/or oxalate nephropathy, or known/suspected ethylene glycol ingestion, or known glucose-6-phosphate dehydrogenase (G6PD) deficiency)
- Use of vitamin C at a dose of > 1 gram daily within the 24 hours preceding first episode of qualifying organ dysfunction during a given ED or ICU admission
- Chronic disease/illness that, in the opinion of the site investigator, have an expected lifespan of < 30 days unrelated to current sepsis diagnosis (e.g., stage IV malignancy, neurodegenerative disease, etc.)
- Pregnancy or known active breastfeeding
- Prisoner or Incarceration
- Current participation in another interventional research study
- Inability or unwillingness of subject or legal surrogate/representative to give written informed consent
Data sourced from ClinicalTrials.gov (NCT03509350) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.