NCT03550794

Thiamine as a Renal Protective Agent in Septic Shock

Thiamine as a Renal Protective Agent in Septic Shock: A Randomized, Controlled Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized, double-blind, placebo controlled study to investigate the effect of intravenous thiamine (vitamin B1) on renal injury in septic shock. Patients admitted with septic shock who have a lactate of at least 2.0mmol/L and do not have pre-existing renal failure requiring dialysis will be eligible for the study. Enrolled patients will be randomized to intravenous thiamine 200mg twice daily for 6 doses or matching placebo. Blood will be drawn at several time points to assess biomarkers of renal injury. Secondary endpoints include need for renal replacement therapy, length of ICU stay, and hospital mortality.

Conditions

• Sepsis
• Kidney Injury
• Thiamine Deficiency

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-09-04
• Primary completion: 2022-04-05
• Completion: 2022-04-05
• First posted: 2018-06-08
• Last updated: 2023-06-27
• Results posted: 2023-06-27

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study