Acute Respiratory Distress Syndrome
Conditions
Keywords
Acute Respiratory Distress Syndrome
Brief summary
Neutrophil elastase (NE) released by neutrophils play an important role in inflammatory cascade and lung tissue injury of ARDS.Inhibition of NE is expected to prevent the pathophysiological process of ARDS and alleviate lung injury. Siverestat sodium is a specific inhibitor of NE, which has been proved by basic and observational clinical studies to be effective in alleviating lung injury of ARDS, but there is a lack of prospective multi-center randomized controlled clinical trials.Therefore, this study was intended to evaluate the efficacy of sivelestat sodium in the treatment of ARDS patients with SIRS in a multicenter randomized controlled clinical trial
Interventions
4.8mg/kg sivelestat sodium was given in 50ml normal saline, and was continuously pumped in the dark for 24h, equivalent to 0.2mg/kg/h.Applied for 5 consecutive days
DRUGSaline
50ml normal saline was continuously pumped in the dark for 24h. Applied for 5 consecutive days
Sponsors
Sichuan Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| oxygenation improvement rate | day 3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 28-day ventilator-free days | day 28 | The 28-day VFDs is defined as the number of study days that the patient is alive and off mechanical ventilation after successful weaning. If a patient dies within 28 days, the VFD is recorded as 0. |
| Invasive mechanical ventilation rate | day 28 | — |
| length of stay in ICU | day 28 | — |
| length of stay in hospital | day 28 | — |
| 28 days mortality | day 28 | — |
| ICU mortality | day 28 | — |
| Incidence of acquired infections | day 28 | — |
| oxygenation improvement rate | day 1 | — |
| incidence of severe adverse effect | day 28 | — |
| activity of neutrophil elastase in plasma | day0 | — |
| concentration of IL-6 | day 0 | — |
| concentration of IL-10 | day 0 | — |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORXiaobo Huang, MD
Sichuan Academy of Medical Sciences
Outcome results
None listed