Comparative Efficacy of Ulinastatin and Vitamin C in Burn-associated Sepsis: A Randomized Controlled Trial.

Abstract

Introduction: Sepsis remains a leading cause of morbidity and mortality in burn patients due to inflammatory dysregulation and immune impairment. Adjunctive therapies such as ulinastatin and Vitamin C may attenuate inflammation and improve organ function, but comparative evidence in burn-associated sepsis is limited. This study compared ulinastatin and Vitamin C in burn patients with sepsis, focusing on survival, organ dysfunction, and inflammatory biomarkers.

Materials and methods: This prospective, randomized, triple-blind controlled trial was conducted over 1 year in the burn intensive care unit (ICU) of a tertiary care center. Seventy adult patients (≥18 years) with 10%-40% total body surface area thermal burns and sepsis as per Sepsis-3 criteria were randomized to receive either ulinastatin (200,000 IU intravenous [IV]) or Vitamin C (1.5 g IV) for 3 days. Biomarkers (interleukin [IL-6], C-reactive protein [CRP], procalcitonin [PCT], and lactate) and clinical parameters (PaO2/FiO2 [P/F] ratio and ICU stay) were assessed at baseline and at 24, 48, and 72 h.

Results: Both the groups showed clinical and biomarker improvement over time. Ulinastatin resulted in significantly greater reductions in IL-6 and CRP by 72 h and was associated with shorter ICU stays, reduced vasopressor requirement, and improved P/F ratio compared to the Vitamin C group. PCT decreased more significantly in the Vitamin C group over time. Mortality was lower in the ulinastatin group (22.8%) compared to the Vitamin C group (34.3%), although not statistically significant (P = 0.289). No adverse drug-related effects were reported.

Conclusion: Both ulinastatin and Vitamin C provided benefit in burn-associated sepsis; however, ulinastatin demonstrated more consistent anti-inflammatory effects and reduced need for intensive supportive measures, supporting its role as an adjunctive therapy.