CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 205 enrolled
Drug / intervention
vitamin C, vitamin B1, hydrocortisone +1 moredrug
Likely dose
vitamin C, vitamin B1, hydrocortisone 1.5gfrom 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/NCT03389555
NCT03389555Phase 3Completed
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Ascorbic Ccid, Hydrocortisone, and Thiamine in Sepsis and Septic Shock - A Randomized, Double-Blind, Placebo-Controlled Trial

Beth Israel Deaconess Medical Center·interventional·Posted Jan 3, 2018·Updated Feb 16, 2021

In Brief

A Phase 3 clinical trial evaluating vitamin C, vitamin B1, hydrocortisone and Normal saline for Sepsis and 2 related conditions. Completed, enrolled 205 participants across 13 sites.

Detailed Summary

In this study, we aim to determine whether the combination of Ascorbic Acid (Vitamin C), Thiamine (Vitamin B1), and Corticosteroids improves the trajectory of organ failure and reduces mortality in patients with sepsis and septic shock as compared to placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSepsis, Septic Shock, Metabolic Disturbance
CountriesUnited States
CollaboratorsOpen Philanthropy

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJan 3, 2018
Enrollment StartFeb 9, 2018
Primary CompletionNov 26, 2019
Study CompletionFeb 28, 2020
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 8.5 years ago

Interventions

vitamin C, vitamin B1, hydrocortisonedrug

Vitamin C (1.5g) plus vitamin B1 (100mg) will be diluted in 100ml 0.9% NACL(normal saline) and administered IV every 6 hours for 4 days or until participant is discharged from the ICU. Hydrocortisone 50mg/ml will be administered via IV push over 1-2 minutes every 6hours for 4 days or until the patient is discharged from the ICU.

Normal salinedrug

Normal saline (0.9% NaCl solution) volume to match all components