At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 95 enrolled
Drug / intervention
Thiamine Hydrochloride +1 moredrug
Likely dose
Thiamine Hydrochloride 200mgfrom 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.
Thiamine as a Renal Protective Agent in Septic Shock: A Randomized, Controlled Study
In Brief
A Phase 2 clinical trial evaluating Thiamine Hydrochloride and Placebo for Sepsis and 2 related conditions. Completed, enrolled 95 participants across 4 sites.
Detailed Summary
This is a randomized, double-blind, placebo controlled study to investigate the effect of intravenous thiamine (vitamin B1) on renal function in septic shock.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSepsis, Kidney Injury, Thiamine Deficiency
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJun 2018
Enrollment StartSep 2018
Primary CompletionApr 2022
TodayJul 2026
First PostedJun 8, 2018
Enrollment StartSep 4, 2018
Primary CompletionApr 5, 2022
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 8.1 years ago
Interventions
Thiamine Hydrochloridedrug
Thiamine hydrochloride is a water soluble vitamin (vitamin B1). 200mg of thiamine hydrochloride in 50ml 0.9%NACL will be administered twice daily for 3 days.
Placebodrug
50ml of 0.9% NACL will serve as the placebo