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RECRUITING
NCT06195267
NA

Protective Effect of Sivelestat Against Negative Pulmonary Function and Organ Dysfunction After Cardiovascular Surgery (PANDA VI)

Sponsor: Nanjing Medical University

View on ClinicalTrials.gov

Summary

Systemic inflammatory response syndrome (SIRS) and multiple organ dysfunction syndrome (MODS) are the major causes of death in patients with cardiovascular diseases. Therefore, the prevention of SIRS and MODS is of great clinical value, and immunomodulatory therapy with sivelestat may be beneficial. This study was designed to test the hypothesis that the administration of sivelestat during the acute phase of cardiovascular diseases will result in a reduced incidence of SIRS and MODS.

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2024-07-01

Completion Date

2025-12-31

Last Updated

2024-11-22

Healthy Volunteers

No

Interventions

DRUG

Sivelestat

The total 24-hour dose of Sivelestat sodium (4.8mg/kg) was dissolved with 50 ml normal saline. The drug flow rate was set at 2ml/h with an intravenous microinfusion pump, and the constant speed infusion was completed in 24h.

DRUG

Blank control

Patients only received standard treatment and care.

Locations (2)

Beijing Anzhen Hospital

Beijing, China

The First Affiliated Hospital of Nanjing Medical University and Jiang ye-fan

Nanjing, China