Effect of Intravenous Thiamine Supplementation on AKI Outcomes in Patients with Sepsis: A Randomized Controlled Trial

Background: Acute kidney injury (AKI) affects 40-50% of sepsis patients and increases mortality by up to 60%. Mitochondrial dysfunction caused by thiamine deficiency has been implicated in sepsis-associated AKI pathogenesis. Despite thiamine's potential role in mitochondrial protection, its efficacy in preventing AKI in sepsis patients remains understudied, with no previous randomized controlled trials specifically designed to evaluate this as a primary outcome. Methods: This single-center, randomized controlled trial enrolled 100 adult patients with early sepsis and preserved baseline renal function. Participants were randomized to receive either thiamine (200 mg IV every 12 hours for 7 days) or standard care. The primary outcome was AKI incidence within 7 days, defined by KDIGO criteria. Secondary outcomes included 28-day mortality, renal replacement therapy (RRT), major adverse kidney events (MAKE), and lactate clearance. Results: All-cause mortality was significantly lower in the thiamine group (4%) compared to the control group (16%, p=0.046). AKI occurred in 22% of thiamine-treated patients versus 40% of controls, representing a clinically meaningful 45% relative risk reduction that approached statistical significance (p=0.052). Major adverse kidney events showed a favorable trend in the thiamine group (p=0.065). Renal replacement therapy requirements and median length of stay were comparable between groups. Thiamine supplementation was well-tolerated with no adverse events reported. Conclusion: In sepsis patients, thiamine supplementation significantly reduced all-cause mortality and showed a strong trend toward AKI reduction. The 45% relative reduction in AKI incidence represents a clinically meaningful effect that may have important implications for sepsis management. These findings suggest thiamine's potential role as a safe, cost-effective adjunctive therapy in sepsis that may improve both survival and renal outcomes. Future research should focus on patients with confirmed thiamine deficiency or more severe illness to further identify specific populations who may benefit most. Funding: Government Support – Non-U.S.