Effect of Early Treatment With Sivelestat Sodium in ARDS Patients

N/AUnknownNCT05020210

Nanfang Hospital, Southern Medical University560 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

560

Conditions

ARDS Inflammatory Response

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Murray lung injury score

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