CompletedPhase 2

Thiamine as a Renal Protective Agent in Septic Shock

United States95 participantsStarted 2018-09-04

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Adult ≥18 years of age
✓. Suspected or Confirmed Infection (defined as collection of a blood/fluid culture and provision of an antimicrobial)
✓. Receipt of a vasopressor agent (e.g. norepinephrine, phenylephrine, vasopressin)
✓. Serum lactate ≥2mmol/L
✓. Creatinine \>1.0mg/dL

Exclusion criteria

✕. Clinical indication for thiamine administration (alcoholism, known or highly suspected deficiency) or treatment with thiamine beyond the amount found in a standard multivitamin within the last 10 days
✕. Renal replacement therapy within the past 30 days
✕. Comfort measures only or anticipated withdrawal of support within 24 hours
✕. Protected populations (pregnant women, prisoners)
✕. Known thiamine allergy

What they're measuring

Kidney Injury Biomarker

Timeframe: Enrollment to 72-hours

Trial details

NCT IDNCT03550794

SponsorBeth Israel Deaconess Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-05

Results submitted2023-05-01

View on ClinicalTrials.gov More Sepsis trials