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A multicenter clinical study on the efficacy and safety of sivelestat sodium in the treatment of patients with ARDS

A multicenter clinical study on the efficacy and safety of sivelestat sodium in the treatment of patients with ARDS

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046772
Enrollment
Unknown
Registered
2021-05-28
Start date
2021-06-01
Completion date
Unknown
Last updated
2022-01-10

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

Conditions

ARDS

Interventions

Test group:Sivelestat sodium
Control group:Normal saline

Sponsors

He'nan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.There is no restriction on gender, over 18 years old; 2.Patients diagnosed with ARDS according to the Berlin ARDS diagnostic guidelines (oxygenation index PaO2/FiO2 <300 mmHg, appendix 1); 3.Patients who can be administered within 72 hours of the onset of ARDS; 4.The doctor performs routine treatment according to the patient's condition; 5.Able to understand and abide by the requirements of the agreement, voluntarily participate in this research and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Patients participating in other clinical studies; 2.Patients with serious lack of diagnosis and treatment data; 3.Women during pregnancy, lactation or women who may be pregnant; 4.According to the judgement of the investigator, patients who are deemed unsuitable for this study group (such as patients with mental illness, patients who may die in a short time.

Design outcomes

Primary

MeasureTime frame
Oxygenation index;Mechanical ventilation time;

Secondary

MeasureTime frame
Inflammation indicators;Lung imaging indicators;Lung function index;Acute Respiratory Distress Syndrome (ARDS) overall outcome;

Countries

China

Contacts

Public ContactQin Bingyu

He'nan Provincial People's Hospital

nicolasby@126.com+86 13633810677

Outcome results

None listed

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