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

NCT05672472 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-01-05

No results posted yet for this study

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.

Conditions

  • Acute Respiratory Distress Syndrome

Interventions

DRUG

Sivelestat sodium

Continuous infusion of sivelestat sodium for 5 days

Sponsors & Collaborators

  • The First Hospital of Jilin University

    lead OTHER

Principal Investigators

  • Dong Zhang, doctor · The First Hospital of Jilin University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-10
Primary Completion
2025-01-10
Completion
2025-02-10

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05672472 on ClinicalTrials.gov