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

NCT05672472 | Unknown DMC

• 1 other identifier: Yuting Li1
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Acute respiratory distress syndrome; Sepsis; Neutrophil elastase inhibitor; Mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Mechanical ventilation time

  Comparison of mechanical ventilation time between the two groups

  2 years

Secondary Outcomes (2)

• Murray Lung Injury Score

  2 years

• ICU length of stay

  2 years

Study Arms (2)

Sivelestat sodium

EXPERIMENTAL

The patients in the test group were given 0.2 mg/kg. h of sivelestat sodium (0.1 g/tube, Shanghai Huilun Jiangsu Pharmaceutical Co., Ltd.) (the daily dose was added to 250 ml of 0.9% sodium chloride) intravenously for 24 hours and 5 consecutive days.

Drug: Sivelestat sodium

sodium chloride

PLACEBO COMPARATOR

The patients in the control group were given 250 ml 0.9% sodium chloride (250ml/bag, Jilin Dubang Pharmaceutical Co., Ltd.) by intravenous pump for 24 hours and 5 consecutive days.

Drug: Sivelestat sodium

Interventions

Sivelestat sodium DRUG

Continuous infusion of sivelestat sodium for 5 days

Also known as: Mechanical ventilation

Sivelestat sodium; sodium chloride

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 1. Adults (aged 18-75)
• \. Patients with ARDS caused by sepsis
• \. Patients admitted to ICU and mechanically ventilated
• \. Patients who can provide informed consent

You may not qualify if:

• \. Pregnant or lactating women;
• \. Patients allergic to planned medication;
• \. Patients who are expected to stay in the ICU for less than 5 days;
• \. Patients included in other trial items;
• \. Other reasons that the researcher thinks are not suitable to participate in this study.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Related Publications (1)

• Miyoshi S, Hamada H, Ito R, Katayama H, Irifune K, Suwaki T, Nakanishi N, Kanematsu T, Dote K, Aibiki M, Okura T, Higaki J. Usefulness of a selective neutrophil elastase inhibitor, sivelestat, in acute lung injury patients with sepsis. Drug Des Devel Ther. 2013 Apr 10;7:305-16. doi: 10.2147/DDDT.S42004. Print 2013.

  PMID: 23596346 RESULT

Related Links

• Usefulness of a selective neutrophil elastase inhibitor, sivelestat, in acute lung injury patients with sepsis

MeSH Terms

Conditions

Respiratory Distress Syndrome; Sepsis

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy

Study Officials

• Dong Zhang, doctor

  The First Hospital of Jilin University

  STUDY DIRECTOR

Central Study Contacts

Yuting Li, master

CONTACT

13943179756; liyuting@jlu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending doctor

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 5, 2023
• Study Start: January 10, 2023
• Primary Completion: January 10, 2025
• Study Completion: February 10, 2025
• Last Updated: January 5, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share