Clinical Efficacy of Ulinastatin for Treatment of Sepsis With Systemic Inflammatory Response Syndrome

Summary

Sepsis is a life-threatening organ dysfunction caused by the maladjusted response of the host to infection. It is a clinical syndrome with high mortality. Studies have confirmed that many cytokines play a vital role in the pathogenesis of sepsis. Ulinastatin (UTI) is a glycoprotein that exists in human blood and can be isolated and purified from human urine. It is a broad-spectrum protease inhibitor. Previous studies have shown that Ulinastatin may have the effect of treating sepsis. 120 septic patients with systemic inflammatory response syndrome were recruited and randomly assigned to the ordinary-dose group, high-dose group, or placebo in a 1:1:1 ratio. The trial was followed up on days 0, 1, 3, 5, 7 and 28. The primary outcome is the change in Sequential Organ Failure Assessment (SOFA) score from baseline to Day 5 (ΔSOFA). All-cause mortality at day 28 is a secondary outcome.

Timeline

Start

2022-11-10

Primary completion

2024-05-28

Completion

2024-06-20

Drugs

Indications