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:
Participant gender:
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.