Effect of Early Treatment With Sivelestat Sodium in ARDS Patients

NCT ID: NCT05020210

Last Updated: 2022-12-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 560 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2023-08-31

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.

Conditions

ARDS; Inflammatory Response

Keywords

sivelestat; ARDS; Inflammatory Response; lung function

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Sivelestat Sodium group

Patients treated with Sivelestat Sodium within 72 hours of the diagnosis of ARDS.

Sivelestat sodium

Intervention Type: DRUG

Patients were treated with Sivelestat Sodium within 72 hours of the diagnosis of ARDS.

Conventional treatment group

Patients not treated with Sivelestat Sodium/Normal Saline after the diagnosis of ARDS

No interventions assigned to this group

Interventions

Sivelestat sodium

Patients were treated with Sivelestat Sodium within 72 hours of the diagnosis of ARDS.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen Hospital of Southern Medical University

OTHER

Sponsor Role: collaborator

Guangdong No.2 Provincial People's Hospital

OTHER

Sponsor Role: collaborator

Foshan Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Southern medical university Nanfang hospital

Guangzhou, , China

Countries

China

Other Identifiers

NFEC-2021-187

Identifier Type: -

Identifier Source: org_study_id