CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 501 enrolled
Drug / intervention
Vitamin C +5 moredrug
Likely dose
Thiamine 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03509350
NCT03509350Phase 3Completed

A Multi-center, Randomized, Placebo-controlled, Double-blind, Adaptive Clinical Trial of Vitamin C, Thiamine and Steroids as Combination Therapy in Patients With Sepsis.

Emory University·interventional·Posted Apr 26, 2018·Updated Apr 13, 2021

In Brief

A Phase 3 clinical trial evaluating Vitamin C, Thiamine, and 4 other interventions for Sepsis. Completed, enrolled 501 participants across 43 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSepsis
CountriesUnited States

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedApr 26, 2018
Enrollment StartAug 22, 2018
Primary CompletionAug 22, 2019
Study CompletionJan 29, 2020
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 8.2 years ago

Interventions

Vitamin Cdrug

Intravenous vitamin C (1.5 grams every 6 hours) will be administered for 4 days or until ICU discharge.

Thiaminedrug

Intravenous thiamine (100 mg every 6 hours) will be administered for 4 days or until ICU discharge.

Hydrocortisonedrug

Intravenous hydrocortisone (50 mg every 6 hours) will be administered for 4 days or until ICU discharge.

Vitamin C Placebodrug

A placebo to match intravenous vitamin C (1.5 grams every 6 hours) will be administered for 4 days or until ICU discharge.

Thiamine Placebodrug

A placebo to match intravenous thiamine (100 mg every 6 hours) will be administered for 4 days or until ICU discharge.

Hydrocortisone Placebodrug

A placebo to match intravenous hydrocortisone (50 mg every 6 hours) will be administered for 4 days or until ICU discharge. Steroids will be used when clinically indicated.