Effect of Neutrophil Elastase Inhibitor (Sivelestat Sodium) on Oxygenation in Patients with Sepsis-Induced Acute Respiratory Distress Syndrome.

Summary

In a multicenter double-blind RCT (n=70) of sepsis-induced ARDS, sivelestat improved oxygenation within five days and triggered early termination due to a potential between-group mortality difference at interim analysis. The findings suggest a possible survival signal but require larger, confirmatory trials.

Key Findings

• Multicenter, double-blind RCT enrolled 70 patients with sepsis-induced ARDS within 48 hours of symptom onset.
• Sivelestat improved oxygenation within the first five days compared with placebo.
• Interim analysis suggested a potential between-group mortality difference, prompting early trial termination; possible reduction in 28-day mortality.

Clinical Implications

Sivelestat may be considered for clinical trial enrollment or compassionate use in selected sepsis-induced ARDS cases; routine use is premature pending larger trials and full safety/efficacy characterization.

Limitations

• Small sample size and early termination reduce power and increase risk of type I error
• Primary endpoint details and full safety profile are not fully described in the abstract

Future Directions

Conduct adequately powered, international RCTs with patient-centered outcomes (mortality, ventilator-free days) and predefined safety monitoring to confirm efficacy.