Protective Effect of Sivelestat Sodium on ARDS in Patients With Sepsis Complicated With Respiratory Failure

• Status: Not yet recruiting
• Trial end date: 2023-10-30
• Target enrollment: 0
• Participant gender: All

Summary

Sivelestat sodium has been approved for use in patients with SIRS and ALI, but whether it can protect patients with sepsis with respiratory failure from developing ARDS remains unknown.The aim of this study was to determine whether sivelestat sodium has a protective effect on ARDS in patients with sepsis complicated with respiratory failure.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southeast University, China
• Treatments: Sivelestat

Criteria

Inclusion Criteria:

• Within 24 hours after admission, sepsis 3.0 diagnostic criteria were met: life threatening organ dysfunction caused by uncontrolled response to infection (initial screening qSOFA ≥ 2, confirmed SOFA ≥ 2);

• Respiratory failure: oxygenation index < 300 mmHg, or SpO2 / FiO2 < 315 (used without blood gas analysis)

• The patients or their family members fully understand the purpose and significance of the trial, voluntarily participate in the clinical trial, and sign the informed consent.

Exclusion Criteria:

• Patients with ARDS were identified at the time of admission;

• Patients who explicitly refused mechanical ventilation;

• Patients with 3 or more extrapulmonary organ injuries and organ failure(single organ SOFA score ≥ 3);

• Patients with home mechanical ventilation (by tracheotomy or noninvasive ventilation, but excluding CPAP / BiPAP, only for patients with obstructive sleep apnea)

• Patients with chronic obstructive pulmonary disease and pulmonary fibrosis who need home oxygen therapy;

• The patient whose expected survival time was less than 48 hours;

• Pregnant women and lactating women;

• Other conditions judged by the researcher not suitable for inclusion.