Effect of Early Treatment With Sivelestat Sodium in ARDS Patients

ARDS Clinical Trial

— siv-ARDS  

Official title:

Effect of Early Treatment With Sivelestat Sodium on Lung Function and Inflammatory Response of ARDS Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05020210
• Other study ID #: NFEC-2021-187
• Status: Enrolling by invitation
• Start date: September 30, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: June 2022
• Source: Nanfang Hospital of Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 560
• Est. completion date: August 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• ARDS
• Inflammatory Response

Intervention

Drug:
• Sivelestat sodium
Patients were treated with Sivelestat Sodium within 72 hours of the diagnosis of ARDS.

Locations

Country	Name	City	State
China	Southern medical university Nanfang hospital	Guangzhou

Sponsors (4)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	Foshan Hospital of Traditional Chinese Medicine, Guangdong No.2 Provincial People's Hospital, Shenzhen Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	The serum levels of IL-6		change from admission to 7 days after enrollment
Secondary	Capillary leakage index	Ultrasound lung water score, capillary leakage index	change from admission to 7 days after enrollment
Secondary	Serum levels of leukocytes		change from admission to 7 days after enrollment
Secondary	Serum electrolyte level		change from admission to 7 days after enrollment
Secondary	renal function	The serum levels of creatinine	change from admission to 7 days after enrollment
Secondary	liver function	The serum levels of ALTand AST	change from admission to 7 days after enrollment
Secondary	myocardial injury indexes	The serum levels of cTnT, CK-MB	change from admission to 7 days after enrollment
Secondary	respiratory function	oxygenation index	change from admission to 7 days after enrollment
Secondary	infection and immunity	The serum levels of CRP	change from admission to 7 days after enrollment
Secondary	infection and immunity	The serum levels of PCT	change from admission to 7 days after enrollment
Secondary	infection and immunity	The serum levels of IL-10 and IL-1ß	change from admission to 7 days after enrollment
Secondary	infection and immunity	The serum levels of TNF-a	change from admission to 7 days after enrollment
Secondary	coagulation function	The serum levels of APTT, PT, TT	change from admission to 7 days after enrollment
Secondary	coagulation function	The serum levels of INR	change from admission to 7 days after enrollment
Secondary	coagulation function	The serum levels of Fbg	change from admission to 7 days after enrollment
Secondary	Incidence of new organ insufficiency/failure after enrollment		up to 2 years
Secondary	length of ventilation/length of hospital stay/length of ICU stay		up to 2 years
Secondary	Mortality rate of in-hospital /28d/90d		90 days after admission