Phase 2
N=95
Thiamine as a Renal Protective Agent in Septic Shock
Sepsis · Kidney Injury · Thiamine Deficiency
Bottom Line
View on ClinicalTrials.gov: NCT03550794 ↗Enrolled (actual)
95
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: Kidney Injury Biomarker — 2.24; 2.79 mg/dL — p=0.07
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Thiamine Hydrochloride (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Beth Israel Deaconess Medical Center
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Kidney Injury Biomarker |
2.24; 2.79 | 0.07 |
| SECONDARY Number of Participants Receiving Renal Replacement Therapy |
6; 10 | 0.34 |
| SECONDARY ICU Free Days |
22.5; 0.0 | 0.002 sig |
| SECONDARY In-hospital Mortality |
15; 25 | 0.14 |
| SECONDARY Number of Participants Experiences Acute Renal Failure |
23; 34 | 0.07 |
| SECONDARY Change in Lactate Level |
1.65; 1.95 | 0.79 |
| SECONDARY Number of Participants With Delirium on Day 3 |
25; 30 | — |
| SECONDARY Change in the Sequential Organ Failure Assessment Score |
8.09; 9.61 | 0.16 |
| SECONDARY Novel Biomarkers of Renal Injury |
763.1; 793.9; 1067898.2; 1558285.0; 1689158.2; 2183175.4 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03550794). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.