Treatment of ARDS With Sivelestat Sodium

Acute Respiratory Distress Syndrome Clinical Trial

— TOAWSS  

Official title:

Efficacy of Sivelestat Sodium in the Treatment of ARDS With SIRS, a Multicenter Double-blind Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04909697
• Other study ID #: SichuanPPHospital
• Status: Recruiting
• Phase: Phase 4
• Start date: April 18, 2022
• Est. completion date: July 30, 2024

Study information

• Verified date: April 2022
• Source: Sichuan Provincial People's Hospital
• Contact: Hongli He, Ph.D.
• Phone: +86-28-87393633
• Email: hhl0408[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 324
• Est. completion date: July 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Drug:
• Sivelestat sodium
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
• Saline
50ml normal saline was continuously pumped in the dark for 24h. Applied for 5 consecutive days

Locations

Country	Name	City	State
China	Sichuan provincial people's hospital	Chengdu	Sichuan Privince

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oxygenation improvement rate		day 3
Primary	ventilator free days		day 28
Secondary	Invasive mechanical ventilation rate		day 28
Secondary	length of stay in ICU		day 28
Secondary	length of stay in hospital		day 28
Secondary	28 days mortality		day 28
Secondary	ICU mortality		day 28
Secondary	Incidence of acquired infections		day 28
Secondary	oxygenation improvement rate		day 1
Secondary	oxygenation improvement rate		day 5
Secondary	incidence of severe adverse effect		day 28
Secondary	activity of neutrophil elastase in plasma		day0
Secondary	activity of neutrophil elastase in plasma		day 1
Secondary	activity of neutrophil elastase in plasma		day 3
Secondary	activity of neutrophil elastase in plasma		day 5
Secondary	concentration of IL-6		day 0
Secondary	concentration of IL-6		day 1
Secondary	concentration of IL-6		day 3
Secondary	concentration of IL-6		day 5
Secondary	concentration of IL-10		day 0
Secondary	concentration of IL-10		day 1
Secondary	concentration of IL-10		day 3
Secondary	concentration of IL-10		day 5