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

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.

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.

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.

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.