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Effect of Early Treatment With Sivelestat Sodium in ARDS Patients

NCT05020210 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 560

Last updated 2022-12-21

No results posted yet for this study

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

Interventions

DRUG

Sivelestat sodium

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

Sponsors & Collaborators

  • Shenzhen Hospital of Southern Medical University

    collaborator OTHER

  • Guangdong No.2 Provincial People's Hospital

    collaborator OTHER

  • Foshan Hospital of Traditional Chinese Medicine

    collaborator OTHER

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2023-05-31
Completion
2023-08-31
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05020210 on ClinicalTrials.gov