Effect of Early Treatment With Sivelestat Sodium in ARDS Patients

NCT05020210 | Unknown DMC FDA Drug

• 1 other identifier: NFEC-2021-187
• Study Type: observational
• Target: 560
• Locations: 1 country
• Sites: 1

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.

Conditions

ARDS; Inflammatory Response

Keywords

sivelestat; ARDS; Inflammatory Response; lung function

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (17)

• 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

Study Arms (2)

Sivelestat Sodium group

Patients treated with Sivelestat Sodium within 72 hours of the diagnosis of ARDS.

Drug: Sivelestat sodium

Conventional treatment group

Patients not treated with Sivelestat Sodium/Normal Saline after the diagnosis of ARDS

Interventions

Sivelestat sodium DRUG

Patients were treated with Sivelestat Sodium within 72 hours of the diagnosis of ARDS.

Sivelestat Sodium group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients developed ARDS in the preceding 72h

You may qualify if:

• 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）;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• Shenzhen Hospital of Southern Medical University: collaborator
• Guangdong No.2 Provincial People's Hospital: collaborator
• Foshan Hospital of Traditional Chinese Medicine: collaborator

Study Sites (1)

Southern medical university Nanfang hospital

Guangzhou, 510515, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 25, 2021
• Study Start: September 30, 2021
• Primary Completion: May 31, 2023
• Study Completion: August 31, 2023
• Last Updated: December 21, 2022

Record last verified: 2022-06

Locations

CN (1)