An observational study in ARDS and Inflammatory Response, sponsored by Nanfang Hospital, Southern Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-21.
Sponsored by Nanfang Hospital, Southern Medical University · Observational
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.
Nanfang Hospital, Southern Medical University is the lead sponsor of 480 studies on the registry; 212 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients developed ARDS in the preceding 72h
Exclusion Criteria:
Patients treated with Sivelestat Sodium within 72 hours of the diagnosis of ARDS.
Drug: Sivelestat sodium
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.
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
Time frame: change from admission to 7 days after enrollment
The serum levels of IL-6
Time frame: change from admission to 7 days after enrollment
Capillary leakage index
Ultrasound lung water score, capillary leakage index
Time frame: change from admission to 7 days after enrollment
Serum levels of leukocytes
Time frame: change from admission to 7 days after enrollment
Serum electrolyte level
Time frame: change from admission to 7 days after enrollment
renal function
The serum levels of creatinine
Time frame: change from admission to 7 days after enrollment
liver function
The serum levels of ALTand AST
Time frame: change from admission to 7 days after enrollment
myocardial injury indexes
The serum levels of cTnT, CK-MB
Time frame: change from admission to 7 days after enrollment
respiratory function
oxygenation index
Time frame: change from admission to 7 days after enrollment
infection and immunity
The serum levels of CRP
Time frame: change from admission to 7 days after enrollment
infection and immunity
The serum levels of PCT
Time frame: change from admission to 7 days after enrollment
infection and immunity
The serum levels of IL-10 and IL-1β
Time frame: change from admission to 7 days after enrollment
infection and immunity
The serum levels of TNF-α
Time frame: change from admission to 7 days after enrollment
coagulation function
The serum levels of APTT, PT, TT
Time frame: change from admission to 7 days after enrollment
coagulation function
The serum levels of INR
Time frame: change from admission to 7 days after enrollment
coagulation function
The serum levels of Fbg
Time frame: change from admission to 7 days after enrollment
Incidence of new organ insufficiency/failure after enrollment
Time frame: up to 2 years
length of ventilation/length of hospital stay/length of ICU stay
Time frame: up to 2 years
Mortality rate of in-hospital /28d/90d
Time frame: 90 days after admission
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Nanfang Hospital, Southern Medical University