TOAWSS: Treatment of ARDS With Sivelestat Sodium

• Sponsor: Sichuan Provincial People's Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04909697
• Collaborator: (none)
• Enrollment: 324
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 27.4
• Patients Per Site Per Month: 11.8

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Distress Syndrome	Drug: Sivelestat sodium; Drug: Saline	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 324 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Efficacy of Sivelestat Sodium in the Treatment of ARDS With SIRS, a Multicenter Double-blind Randomized Controlled Clinical Trial
• Actual Study Start Date: Apr 18, 2022
• Anticipated Primary Completion Date: Jun 30, 2024
• Anticipated Study Completion Date: Jul 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Saline	Drug: Saline; 50ml normal saline was continuously pumped in the dark for 24h. Applied for 5 consecutive days
Experimental: Sivelestat Sodium	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

Outcome Measures

Primary Outcome Measures

1. oxygenation improvement rate [day 3]

2. ventilator free days [day 28]

Secondary Outcome Measures

1. Invasive mechanical ventilation rate [day 28]

2. length of stay in ICU [day 28]

3. length of stay in hospital [day 28]

4. 28 days mortality [day 28]

5. ICU mortality [day 28]

6. Incidence of acquired infections [day 28]

7. oxygenation improvement rate [day 1]

8. oxygenation improvement rate [day 5]

9. incidence of severe adverse effect [day 28]

10. activity of neutrophil elastase in plasma [day0]

11. activity of neutrophil elastase in plasma [day 1]

12. activity of neutrophil elastase in plasma [day 3]

13. activity of neutrophil elastase in plasma [day 5]

14. concentration of IL-6 [day 0]

15. concentration of IL-6 [day 1]

16. concentration of IL-6 [day 3]

17. concentration of IL-6 [day 5]

18. concentration of IL-10 [day 0]

19. concentration of IL-10 [day 1]

20. concentration of IL-10 [day 3]

21. concentration of IL-10 [day 5]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sichuan provincial people's hospital	Chengdu	Sichuan Privince	China

Sponsors and Collaborators

• Sichuan Provincial People's Hospital

Investigators

• Principal Investigator: Xiaobo Huang, MD, Sichuan Academy of Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: He Hongli, Principal Investigator, Sichuan Provincial People's Hospital
• ClinicalTrials.gov Identifier: NCT04909697
• Other Study ID Numbers: SichuanPPHospital
• First Posted: Jun 2, 2021
• Last Update Posted: Apr 19, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by He Hongli, Principal Investigator, Sichuan Provincial People's Hospital: Acute Respiratory Distress Syndrome
• Additional relevant MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Sivelestat

Study Results

No Results Posted as of Apr 19, 2022