Treatment of ARDS With Sivelestat Sodium

Launched by SICHUAN PROVINCIAL PEOPLE'S HOSPITAL · May 26, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called sivelestat sodium to help patients with Acute Respiratory Distress Syndrome (ARDS), a serious condition that affects breathing. The trial aims to see if sivelestat can reduce lung injury by blocking a substance called neutrophil elastase, which is known to cause inflammation and damage in the lungs. This study is important because while previous research has shown promise, there haven't been enough large-scale clinical trials to confirm its effectiveness.

To participate in this trial, individuals must be between 18 and 75 years old and diagnosed with ARDS based on specific criteria. Participants should have a certain level of oxygen in their blood and must provide written consent to join. Patients with certain conditions, like chronic lung disease or severe health issues, may not be eligible. Those who qualify can expect to receive the study medication and will be monitored closely by the medical team throughout the trial. This research could potentially lead to better treatments for ARDS in the future.

Gender

ALL

Eligibility 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