Clinical trial NCT05020210: Effect of Early Treatment With Sivelestat Sodium in ARDS Patients
Official title: Effect of Early Treatment With Sivelestat Sodium on Lung Function and Inflammatory Response of ARDS Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ARDS
Inflammatory Response
Keywords: sivelestat
ARDS
Inflammatory Response
lung function
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Shenzhen Hospital of Southern Medical University
name: Guangdong No.2 Provincial People's Hospital
name: Foshan Hospital of Traditional Chinese Medicine
First posted: 2021-08-25
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients developed ARDS in the preceding 72h

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Murray lung injury score
timeFrame: change from admission to 7 days after enrollment
measure: The serum levels of IL-6
timeFrame: change from admission to 7 days after enrollment
Secondary outcomes:
measure: Capillary leakage index
timeFrame: change from admission to 7 days after enrollment
measure: Serum levels of leukocytes
timeFrame: change from admission to 7 days after enrollment
measure: Serum electrolyte level
timeFrame: change from admission to 7 days after enrollment
measure: renal function
timeFrame: change from admission to 7 days after enrollment
measure: liver function
timeFrame: change from admission to 7 days after enrollment
measure: myocardial injury indexes
timeFrame: change from admission to 7 days after enrollment
measure: respiratory function
timeFrame: change from admission to 7 days after enrollment
measure: infection and immunity
timeFrame: change from admission to 7 days after enrollment
measure: infection and immunity
timeFrame: change from admission to 7 days after enrollment
measure: infection and immunity
timeFrame: change from admission to 7 days after enrollment
measure: infection and immunity
timeFrame: change from admission to 7 days after enrollment
measure: coagulation function
timeFrame: change from admission to 7 days after enrollment
measure: coagulation function
timeFrame: change from admission to 7 days after enrollment
measure: coagulation function
timeFrame: change from admission to 7 days after enrollment
measure: Incidence of new organ insufficiency/failure after enrollment
timeFrame: up to 2 years
measure: length of ventilation/length of hospital stay/length of ICU stay
timeFrame: up to 2 years
measure: Mortality rate of in-hospital /28d/90d
timeFrame: 90 days after admission
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Southern medical university Nanfang hospital
Study officials:
References: