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A single-center, prospective, open-label study of the efficacy of sivelestat sodium in patients with post-surgical acute lung injury

A single-center, prospective, open-label study of the efficacy of sivelestat sodium in patients with post-surgical acute lung injury

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098962
Enrollment
Unknown
Registered
2025-03-17
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

Acute lung injury after surgery

Interventions

Group A (sivelestat sodium) :Group A (sivelestat sodium group) : the patients were given sivelestat sodium 4.8 mg/kg+50 ml normal saline, which was continuously pumped for 24 h away from light, equiva
It has been applied for 5 consecutive days.
Group B (saline control):Group B (normal saline control group) : 50 ml normal saline was given, continuously pumped intravenously for 24 h, and continuously applied for 5 days.

Sponsors

Shaoxing People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) ALI/ARDS patients aged >=18 years; (2) Meet the Berlin diagnostic criteria (see annex); (3) Patients who can be administered within 72 hours of the onset of ALI/ARDS; (4) Can understand and comply with the requirements of the agreement, and voluntarily sign the informed consent;

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) Patients who, as judged by the investigator, are not suitable for the study group (such as patients suffering from mental illness); (5) Patients diagnosed with primary neutropenia (absolute neutrophil count <2?109/L);

Design outcomes

Primary

MeasureTime frame
Oxygenation index (PaO2/FiO2) and 28 days of mechanical ventilation;

Secondary

MeasureTime frame
Inflammatory markers at day 0, 1, 3, 5: WBC, CRP, PCT, IL-6;Overall outcome of ARDS: length of stay in ICU, ICU mortality, in-hospital mortality, 28-day mortality;Safety indicators: Blood routine, liver and kidney function, coagulation function at day 0, 1, 3 and 5;Adverse event;Scores: SOFA score at day 0, 1, 3 and 5, APACHE II, Murray lung injury score, chest radiograph /CT score;

Countries

China

Contacts

Public ContactXuedong Sun

Shaoxing People's Hospital

sunxd@usx.edu.cn+86 137 7731 6811

Outcome results

None listed

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