Treatment of Acute Respiratory Distress Syndrome with Sivelestat Sodium
Efficacy of Sivelestat Sodium in the Treatment of ARDS With SIRS, a Multicenter Double-blind Randomized Controlled Clinical Trial
This study is testing if a new medication called sivelestat sodium can help patients with Acute Respiratory Distress Syndrome and Systemic Inflammatory Response Syndrome by protecting their lungs from damage.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 324 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sichuan Provincial People's Hospital Academic / other |
| Locations | 1 site (Chengdu, Sichuan Privince) |
| Trial ID | NCT04909697 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy of sivelestat sodium, a specific inhibitor of neutrophil elastase, in treating patients with Acute Respiratory Distress Syndrome (ARDS) who also have Systemic Inflammatory Response Syndrome (SIRS). The study aims to prevent lung tissue injury caused by the inflammatory cascade associated with ARDS. It is a multicenter randomized controlled trial designed to provide robust evidence on the effectiveness of this treatment approach. Participants will receive either sivelestat sodium or saline as a control.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 who meet the Berlin diagnostic criteria for ARDS and have specific oxygenation levels.
Not a fit: Patients with chronic respiratory diseases, single cardiogenic pulmonary edema, or those with a poor prognosis are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients suffering from ARDS by reducing lung injury.
How similar studies have performed: While previous observational studies have shown promise for sivelestat sodium, this is one of the first prospective multicenter randomized controlled trials evaluating its efficacy in ARDS.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Males and females \> 18 years old and \<75 years old (non-pregnant, non-lactating females). 2. Patients fulfilled the Berlin diagnostic criteria of acute respiratory distress syndrome, with a arterial oxygen partial pressure (PaO2) to fraction of inspired oxygen (FiO2) between 150 mmHg and 300 mmHg. 3. Signed written informed consent has been obtained Exclusion Criteria: 1. History of chronic respiratory disease 2. Single cardiogenic pulmonary edema 3. Apach2 score ≥21 points 4. Complicated with end-stage disease, or poor prognosis judged by the clinical doctor in charge 5. ARDS course\>3 days 6. Agranulocytosis or receiving immunosuppressive agents or high doses of corticosteroids (methylprednisolone\>40mg/day) 7. Pregnancy or breastfeeding 8. Participated in this study 9. Do not agree to participate in this experiment
Where this trial is running
Chengdu, Sichuan Privince
- Sichuan provincial people's hospital — Chengdu, Sichuan Privince, China (Recruiting)
Study contacts
- Principal investigator: Xiaobo Huang, MD — Sichuan Academy of Medical Sciences
- Study coordinator: Hongli He, Ph.D.
- Email: hhl0408@163.com
- Phone: +86-28-87393633
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.