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Thiamine as a Renal Protective Agent in Septic Shock

NCT03550794 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2023-06-27

Study results available
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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.

Conditions

  • Sepsis
  • Kidney Injury
  • Thiamine Deficiency

Interventions

DRUG

Thiamine Hydrochloride

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.

DRUG

Placebo

50ml of 0.9% NACL will serve as the placebo

Sponsors & Collaborators

Principal Investigators

  • Ari Moskowitz, MD · Beth Israel Deaconess Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-04
Primary Completion
2022-04-05
Completion
2022-04-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03550794 on ClinicalTrials.gov