Effect of Early Treatment With Sivelestat Sodium in ARDS Patients (siv-ARDS)

Nanfang Hospital, Southern Medical University

Status

Invitation-only

Conditions

Inflammatory Response

ARDS

Treatments

Drug: Sivelestat sodium

Study type

Observational

Funder types

Other

Identifiers

NCT05020210

NFEC-2021-187

Details and patient eligibility

About

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.

Enrollment

560 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.