Effect of Early Treatment With Sivelestat Sodium in ARDS Patients

• Conditions: Inflammatory Response; ARDS
• Interventions: Drug: Sivelestat sodium

• Registration Number: NCT05020210
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

This study is a multicenter, prospective, observational cohort study. The subjects were patients who developed ARDS within the preceding 72h. They were divided into 2 groups based on the use of sivelestat sodium which was determined by the physician in charge based on the condition of the patients: sivelestat sodium group and conventional treatment group. 560 patients were planned to be enrolled, with 280 patients in each group. In the sivelestat sodium group, patients were treated with sivelestat sodium within 72h of the diagnosis of ARDS. After 5 days of sivelestat treatment, sivelestat treatment should be stopped if the oxygenation index is greater than 300mmHg for at least 3 consecutive times; otherwise, sivelestat treatment should be continued until the oxygenation index is greater than 300mmHg for at least 3 consecutive times; if sivelestat treatment is continued until the 14th day, the drug should be stopped regardless of the oxygenation situation. Baseline data and Murray lung injury score, inflammatory markers, routine test results, duration of ECMO use/length of hospital stay/length of ICU stay were recorded at 1, 3,5, and 7 days after patients were enrolled, and patients were followed up on the 28th and 90th days.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-27
• Study First Submitted QC: 2021-08-18
• Study First Posted: 2021-08-25
• Study Start: 2021-09-30
• Status Verified: 2022-06
• Last Update Submitted: 2022-12-19
• Last Update Posted: 2022-12-21
• Primary Completion: 2023-05-31
• Study Completion: 2023-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 560

Inclusion Criteria

• Voluntarily signed informed consent;
• ≥18 years old;
• Patients developed ARDS in the preceding 72h;
• The total scores of the Murray lung injury scores were greater than 6 （When lung compliance was not measured, the total scores of the other three scores were greater than 4）;

Exclusion Criteria

• Pregnancy or lactation;
• ARDS was diagnosed for more than 72 hours;
• Sivelestat sodium was used for treatment prior to enrollment;
• Patients with more than 3 extra-pulmonary organ injuries/failure;
• Severe chronic liver disease (Child-pugh grade C);
• Previous history of allergy to sivelestat sodium or any of its ingredients or preservatives;
• Patients whose primary disease cannot be effectively controlled;
• Patients judged by the investigator to be unsuitable for participation in this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sivelestat Sodium group	Sivelestat sodium	Patients treated with Sivelestat Sodium within 72 hours of the diagnosis of ARDS.

Primary Outcome Measures

Name	Time	Method
The serum levels of IL-6	change from admission to 7 days after enrollment
Murray lung injury score	change from admission to 7 days after enrollment	The Lung Injury Score can be used to assess the adult patient for the extent of acute pulmonary damage. It can be used both at the onset of a lung disorder and during the course of the illness to monitor changing lung involvement.; Parameters; * chest X-ray evaluated for alveolar consolidation; * ratio of the partial pressure of oxygen in arterial blood to the inspiratory fraction of oxygen; * PEEP level if ventilated; * respiratory compliance if known

Secondary Outcome Measures

Name	Time	Method
liver function	change from admission to 7 days after enrollment	The serum levels of ALTand AST
Capillary leakage index	change from admission to 7 days after enrollment	Ultrasound lung water score, capillary leakage index
Serum levels of leukocytes	change from admission to 7 days after enrollment
Serum electrolyte level	change from admission to 7 days after enrollment
renal function	change from admission to 7 days after enrollment	The serum levels of creatinine
myocardial injury indexes	change from admission to 7 days after enrollment	The serum levels of cTnT, CK-MB
infection and immunity	change from admission to 7 days after enrollment	The serum levels of TNF-α
coagulation function	change from admission to 7 days after enrollment	The serum levels of Fbg
Incidence of new organ insufficiency/failure after enrollment	up to 2 years
respiratory function	change from admission to 7 days after enrollment	oxygenation index
length of ventilation/length of hospital stay/length of ICU stay	up to 2 years
Mortality rate of in-hospital /28d/90d	90 days after admission

Trial Locations

Locations (1)

Southern medical university Nanfang hospital; 🇨🇳 Guangzhou, China