Vitamin C, Thiamine, and Steroids in Sepsis

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.

Conditions

• Sepsis

Interventions

DRUG

Vitamin C

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

DRUG

Thiamine

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

DRUG

Hydrocortisone

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

DRUG

Vitamin C Placebo

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

DRUG

Thiamine Placebo

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

DRUG

Hydrocortisone Placebo

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.

Sponsors & Collaborators

• The Marcus Foundation

  collaborator OTHER

• Emory University

  lead OTHER

Principal Investigators

• Jonathan Sevransky, MD, MHS · Emory University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-08-22

Primary Completion

2019-08-22

Completion

2020-01-29

FDA Drug

Yes

Countries

• United States

Study Locations