NCT05020210|UnknownDMCFDA Drug
Effect of Early Treatment With Sivelestat Sodium in ARDS Patients
siv-ARDS
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Sponsor study identifier
observational
560
1 country
1
Study Start
September 30, 2021
Actual (reported)Primary Completion
May 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 27, 2021
Actual (reported)August 25, 2021
Actual (reported)September 30, 2021
Actual (reported)May 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
change from admission to 7 days after enrollment
The serum levels of IL-6
change from admission to 7 days after enrollment
Capillary leakage index
change from admission to 7 days after enrollment
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
liver function
change from admission to 7 days after enrollment
Patients treated with Sivelestat Sodium within 72 hours of the diagnosis of ARDS.
Patients not treated with Sivelestat Sodium/Normal Saline after the diagnosis of ARDS
Patients were treated with Sivelestat Sodium within 72 hours of the diagnosis of ARDS.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients developed ARDS in the preceding 72h
Southern medical university Nanfang hospital
Guangzhou, 510515, China
blood
First Submitted
July 27, 2021
First Posted
August 25, 2021
Study Start
September 30, 2021
Actual (reported)Primary Completion
May 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Treatment of ARDS With Sivelestat Sodium
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Study Completion
August 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 21, 2022
Record last verified: 2022-06
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Source: ClinicalTrials.gov.
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