At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 120 enrolled

Drug / intervention

Vitamin C +1 moredrug

Likely dose

Vitamin C 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/NCT03592277

NCT03592277Phase 2Completed

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Vitamins B1 and C to Improve Outcomes in Patients With Severe Sepsis

Trinity Health Of New England·interventional·Posted Jul 19, 2018·Updated Sep 28, 2022

In Brief

A Phase 2 clinical trial evaluating Vitamin C and Vitamin B1 for Sepsis and Septic Shock. Completed, enrolled 120 participants across 1 site.

Detailed Summary

Investigators propose to investigate the use of IV vitamins B1 and C in a randomized, double-blinded, prospective trial to determine if these medications decrease mortality rates in patients with severe sepsis or septic shock.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsSepsis, Septic Shock

CountriesUnited States

Collaborators--

Timeline

Phase 2CompletedFinished

20192020202120222023202420252026

First PostedJul 2018

Enrollment StartSep 2018

Primary CompletionFeb 2021

TodayJul 2026

First PostedJul 19, 2018

Enrollment StartSep 14, 2018

Primary CompletionFeb 22, 2021

TodayJul 2, 2026

Enrollment to primary: 2.4 yearsPosted 8.0 years ago

Interventions

Vitamin Cdrug

Patients will receive 1.5g of vitamin C in 100mL of 0.9% sodium chloride (normal saline) every six hours for four days or until discharge from the ICU, whichever happens first (seventeen dose maximum).

Vitamin B1drug

Patients will also receive 200 mg of IV vitamin B1 every 12 hours in 50 mL of normal saline for four days or until ICU discharge (whichever happens first, nine dose maximum).