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A real-world study of sivelestat in the treatment of acute lung injury/acute respiratory distress syndrome in patients with acute exacerbation of interstitial lung disease

A real-world study of sivelestat in the treatment of acute lung injury/acute respiratory distress syndrome in patients with acute exacerbation of interstitial lung disease

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400083364
Enrollment
Unknown
Registered
2024-04-23
Start date
2024-04-27
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial lung disease

Interventions

Sivelestat sodium application group:NA
Sivelestat sodium non-application group:NA

Sponsors

Affiliated Hospital of Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: (1) Patients aged =18 years old; (2) Patients met the diagnostic criteria for AE-ILD (see Appendix I for details); (3) Patients received sivelestat within 72 hours after onset; (4) Patients received conventional treatment in accordance with their conditions; (5) Patients could understand and abide by the requirements of the protocol and signed the informed consent voluntarily to participate in this study;

Exclusion criteria

Exclusion criteria: (1) Patients participating in other clinical studies; (2) Patients with serious lack of diagnosis and treatment data; (3) pregnant women, breastfeeding women or women who may be pregnant; (4) Combined with 3 or more severe organ dysfunction on the basis of the primary disease; (5) Patients diagnosed with neutropenia (absolute neutrophil count <2?109/L); (6) Patients who are receiving chemotherapeutics and other immunomodulatory drugs (such as recombinant human granulocyte colony-stimulating factor, thymus fasin, Xuebijin, ulinastatin, etc.); (7) patients who, as judged by the investigator, are not suitable for the study group (such as patients suffering from mental illness);

Design outcomes

Primary

MeasureTime frame
dium: Oxygenation index improvement rate at day 5 and 7 day;

Secondary

MeasureTime frame
Inflammatory index;Respiratory support mode and duration;Lung function;Arterial blood gas (partial pressure of oxygen, partial pressure of carbon dioxide);D-D dimer content or concentration;28 day mortality rate;

Countries

China

Contacts

Public ContactBi Chen

Affiliated Hospital of Xuzhou Medical University

chenbi207@126.com+86 150 0520 7551

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026