Neutrophil Elastase Inhibitor in Treatment of ARDS Patients With Mechanical Ventilation Caused by Sepsis

• Status: Not yet recruiting
• Trial end date: 2025-02-10
• Target enrollment: 0
• Participant gender: All

Summary

Sepsis is a life-threatening organ dysfunction caused by the host's maladjusted response to infection. It is one of the common clinical critical diseases, often accompanied by multiple organ failure, immune imbalance and high mortality. Sepsis is a syndrome of physiological, pathological and biochemical abnormalities caused by infection. Its incidence rate and prevalence have been on the rise in the past few years. Sepsis has greatly endangered the lives and health of the public. Among them, ARDS is a fatal complication of sepsis and a common critical illness syndrome in ICU. At present, the conventional treatment for ARDS caused by sepsis is still limited to indirect supportive therapy such as primary disease treatment, infection control, mechanical ventilation support, and nutrition improvement, lacking specific direct treatment methods. So far, the drug treatment effect of ARDS at home and abroad is not satisfactory. Therefore, it has become an urgent task to find a new treatment strategy to alleviate ARDS. Neutrophil elastase inhibitors can reversibly and competitively inhibit the release of neutrophil elastase, inhibit the activation of neutrophils and the infiltration of inflammatory cells in the lungs, alleviate the release of inflammatory mediators, and thus improve respiratory function, which has a good protective effect on various experimental ARDS. However, the efficacy of neutrophil elastase inhibitor represented by sivelestat sodium in the treatment of ARDS has reached a relatively consistent positive conclusion in animal experiments, while the results of clinical studies are different. These differences in clinical research still need further analysis, research and verification in clinical trials.

At present, the clinical studies of neutrophil elastase inhibitors in the treatment of sepsis induced ARDS are very few, and there is a lack of related prospective randomized controlled clinical studies. Therefore, further prospective clinical trials are needed to evaluate the therapeutic effect of neutrophil elastase inhibitors on sepsis induced ARDS patients. This study is intended to determine whether neutrophil elastase inhibitor can reduce the mechanical ventilation time, Murray lung injury score, ICU hospitalization time and 28-day mortality of septic ARDS patients compared with the control group through a single center randomized controlled trial, so as to provide a new basis for the treatment strategy of septic ARDS patients.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Hospital of Jilin University
• Treatments: Sivelestat

Criteria

Inclusion Criteria:

• 1. Adults (aged 18-75)

2. Patients with ARDS caused by sepsis

3. Patients admitted to ICU and mechanically ventilated

4. Patients who can provide informed consent

Exclusion Criteria:

• 1. Pregnant or lactating women;

2. Patients allergic to planned medication;

3. Patients who are expected to stay in the ICU for less than 5 days;

4. Patients included in other trial items;

5. Other reasons that the researcher thinks are not suitable to participate in this study.