Efficacy of Sivelestat Sodium in the Therapy of Critically ill Patients at high risk of developing ARDS due to SIRS: A Multicenter Prospective Study

Abstract Background Sivelestat sodium has been proposed as a therapeutic strategy to mitigate respiratory dysfunction and reduce the need for mechanical ventilation in critically ill patients. Its clinical usage remains controversial. This multicenter prospective study aimed to evaluate the efficacy of sivelestat sodium in patients presenting high-risk of developing acute respiratory distress syndrome (ARDS) due to systemic inflammatory response syndrome with an oxygenation index (PaO2/FIO2 ratio; P/F ratio) between 100–400 mmHg upon ICU administration. Methods Eighty-two patients were divided into two groups: sivelestat group and conventional group. Clinical information, including vital sign, etiology, scoring systems for illness severity, laboratory test data, P/F ratio and chronic comorbidities were collected at the time of administration. The primary end points were invasive mechanical ventilation ratio and ventilator-free days (VFDs). Besides, the severe ARDS ratio, changes of P/F ratio (∆P/F ratio), levels of inflammatory factors (procalcitonin (PCT), C-reactive protein (CRP) and Interleukin-6 (IL-6)) before and after 7 days therapy were also collected. Results Prescribe sivelestat sodium, as compared with conventional therapy, did not have a significant effect on mechanical ventilation ratio or severe ARDS ratio. Notably, sivelestat group exhibited significantly higher VFDs and an improved ∆P/F ratio in mild and moderate ARDS subgroup. Additionally, the ∆P/F ratio was significantly elevated on the fifth day following therapy initiation. Furthermore, there was a reduction in the levels of CRP and PCT, indicating a potential anti-inflammatory effect. Conclusion The results facilitate a randomized controlled trial to determine sivelestat sodium may be considered to alleviate inflammation response and protect patients with mild or moderate ARDS.