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Study on the therapeutic effect of sivelestat sodium in patients with high risk of ARDS

Study on the therapeutic effect of sivelestat sodium in patients with high risk of ARDS

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064094
Enrollment
Unknown
Registered
2022-09-26
Start date
2022-09-12
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

Acute Respiratory Distress Syndrome

Interventions

control:No
sivillistat sodium group:Sivillistat sodium is inistered

Sponsors

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 and 90; 2. Patients admitted to ICU due to high risk factors of ALI/ARDS (pneumonia, aspiration, physical and chemical factors, sepsis, pancreatitis, etc.) with oxygenation index of 200-400mmHg; 3. Consistent with the diagnosis of systemic inflammatory response syndrome (SIRS) : body temperature >38? or 90 times/min; Breathing > 20 beats/min or hyperventilation,PaCO212×109/L or 10%; 4. Serum IL-6 or CRP was higher than normal; 5. X-ray chest film generally increased density in both lung fields, decreased brightness, increased and thickened lung texture, scattered patchy shadows of increased density, namely diffuse lung infiltration shadow

Exclusion criteria

Exclusion criteria: 1. Age90-year old; 2. Endotracheal intubation or tracheotomy has been performed; 3. Allergic to sivillistat sodium; 4. Patients with chronic obstructive pulmonary disease, bronchial asthma and myasthenia gravis; 5. Severe liver and kidney failure; Severe hemodynamic instability; Severe heart block or cardiac insufficiency; 6. Patients deemed unsuitable by the investigator

Design outcomes

Primary

MeasureTime frame
Utilization rate of mechanical ventilation;Incidence of severe ARDS;

Secondary

MeasureTime frame
SOFA score;APACHE ? score;white blood cell count;red blood cell count;hemoglobin;blood platelet count;urea;creatinine;bicarbonate radical;eGFR;alanine transaminase;glutamic oxalacetic transaminase;total protein;albumin;globulin;total bilirubin;direct bilirubin;indirect bilirubin;alkaline phosphatase;? glutamyl transpeptidase;total cholesterol;lactic dehydrogenase;thrombin time;prothrombin time;activated partial thromboplastin time;fibrinogen;procalcitonin;Interleukin 6;APACHE ? score;SOFA score;CPOT score;RASS score;arterial pressure;heart rate;respiratory rate;oxygen index;temperature;CRP;

Countries

China

Contacts

Public ContactWei Zhu
tjjzkzw512@163.com13971209138

Outcome results

None listed

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