Effect of Early Treatment With Sivelestat Sodium in ARDS Patients (siv-ARDS)

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Inflammatory Response; ARDS
• Intervention / Treatment: Drug: Sivelestat sodium

• Study Type: Observational
• Enrollment (Anticipated): 560

Contacts and Locations

Study Locations

• China
  • Guangzhou, China, 510515
    • Southern Medical University Nanfang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients developed ARDS in the preceding 72h

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sivelestat Sodium group; Patients treated with Sivelestat Sodium within 72 hours of the diagnosis of ARDS.	Drug: Sivelestat sodium; Patients were treated with Sivelestat Sodium within 72 hours of the diagnosis of ARDS.
Conventional treatment group; Patients not treated with Sivelestat Sodium/Normal Saline after the diagnosis of ARDS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Capillary leakage index	Ultrasound lung water score, 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	The serum levels of creatinine	change from admission to 7 days after enrollment
liver function	The serum levels of ALTand AST	change from admission to 7 days after enrollment
myocardial injury indexes	The serum levels of cTnT, CK-MB	change from admission to 7 days after enrollment
respiratory function	oxygenation index	change from admission to 7 days after enrollment
infection and immunity	The serum levels of CRP	change from admission to 7 days after enrollment
infection and immunity	The serum levels of PCT	change from admission to 7 days after enrollment
infection and immunity	The serum levels of IL-10 and IL-1β	change from admission to 7 days after enrollment
infection and immunity	The serum levels of TNF-α	change from admission to 7 days after enrollment
coagulation function	The serum levels of APTT, PT, TT	change from admission to 7 days after enrollment
coagulation function	The serum levels of INR	change from admission to 7 days after enrollment
coagulation function	The serum levels of Fbg	change from admission to 7 days after enrollment
Incidence of new organ insufficiency/failure after enrollment		up to 2 years
length of ventilation/length of hospital stay/length of ICU stay		up to 2 years
Mortality rate of in-hospital /28d/90d		90 days after admission

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University
• Collaborators: Guangdong No.2 Provincial People's Hospital; Foshan Hospital of Traditional Chinese Medicine; Shenzhen Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2021
• Primary Completion (Anticipated): May 31, 2023
• Study Completion (Anticipated): August 31, 2023

Study Registration Dates

• First Submitted: July 27, 2021
• First Submitted That Met QC Criteria: August 18, 2021
• First Posted (Actual): August 25, 2021

Study Record Updates

• Last Update Posted (Estimate): December 21, 2022
• Last Update Submitted That Met QC Criteria: December 19, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: lung function; ARDS; Inflammatory Response; sivelestat
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Serine Proteinase Inhibitors; Sivelestat
• Other Study ID Numbers: NFEC-2021-187

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No