Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06195267

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
500 (estimated)
Sponsor
Nanjing Medical University · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGSivelestatThe 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.
DRUGBlank controlPatients only received standard treatment and care.

Timeline

Start date
2024-07-01
Primary completion
2025-12-31
Completion
2025-12-31
First posted
2024-01-08
Last updated
2024-11-22

Locations

2 sites across 1 country: China

Source: ClinicalTrials.gov record NCT06195267. Inclusion in this directory is not an endorsement.