Acute respiratory distress syndrome
Conditions
Interventions
Sivelestat sodium:Group A (sevelamer sodium group): sevelamer sodium 4.8 mg/kg + 50 ml saline was given and continuously pumped for 24 h, avoiding light, equivalent to 0.2 mg/kg/h
it was applied for 5 consecutive days.
Blank control group:None
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Male or female, 18 years <= age <= 75 years; 2) Meet the new global definition of ARDS 2023 diagnostic criteria; 3) Patients who are able to administer the drug within 72 hours of the time of ARDS diagnosis; 4) Able to understand and comply with the requirements of the protocol, voluntarily participate in this study and sign the informed consent form;
Exclusion criteria
Exclusion criteria: 1) Patients who participate in other exploratory clinical studies at the same time; 2) Pregnant women, lactating women or women who may be pregnant; 3) The patient or family refuses to sign the informed consent form; 4) Allergy to experimental drugs; 5) Severe chronic respiratory diseases: autoimmune diseases involve the lungs, chronic respiratory failure, such as moderate and severe chronic obstructive pulmonary disease (FEV1<70%pred or clinical judgment with obvious airway obstructive disease), bronchiectasis or pulmonary interstitial fibrosis (with an area of more than 20% of lung volume); patients with diaphragm or respiratory muscle weakness; 6) Patients with advanced tumors or malignant disease (expected survival of no more than 3 months); 7) Intracranial hypertension, cerebral hernia, deep coma [Glasgow coma score due to primary central nervous system disease (GSC) <8 points] patients; 8) Patients with severe missing data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite endpoint combining mortality at 28 days with time without mechanical ventilation; | — |
Secondary
| Measure | Time frame |
|---|---|
| 28-day morbidity and mortality in patients with ARDS;Murray Lung Injury Score;clinical pulmonary infection score(CPIS);Oxygenation index (PaO2/FiO2) on days 3, 5, and 7 (or at the end of treatment) in patients treated with sevelamer sodium;White Blood Cell(WBC);Neutrophil-to-Lymphocyte Ratio(NLR);C-reactive protein(CRP);Procalctonin(PCT);Interleukin-6(IL-6);Plateau pressure at day 7 (or end of treatment);Drive pressure at day 7 (or end of treatment);Tidal volume at day 7 (or end of treatment);Rate of intubation in non-intubated ARDS patients at 7 days of treatment (or at end of treatment);ICU days of hospitalization;Total days of hospitalization;ICU morbidity and mortality;In-hospital morbidity and mortality;SOFA scores before the start and at the end of treatment;APACHE II scores before the start and at the end of treatment; | — |
Countries
China
Contacts
Public ContactTongwen Sun
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed