Thiamine as a Renal Protective Agent in Septic Shock

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Treatments: Protective Agents; Thiamine; Vitamins

Criteria

Inclusion Criteria:

1. Adult ≥18 years of age

2. Suspected or Confirmed Infection (defined as collection of a blood/fluid culture and provision of an antimicrobial)

3. Receipt of a vasopressor agent (e.g. norepinephrine, phenylephrine, vasopressin)

4. Serum lactate ≥2mmol/L

5. Creatinine >1.0mg/dL

Exclusion Criteria:

1. 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

2. Renal replacement therapy within the past 30 days

3. Comfort measures only or anticipated withdrawal of support within 24 hours

4. Protected populations (pregnant women, prisoners)

5. Known thiamine allergy