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

Study acronym: PANDA
StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated November 22, 2024 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Site contacts updated at 2 of 2 sitesv3
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
    • Enrollment target: 200 to 500
    • Start date changed from estimate of Feb 1, 2024 to Jul 1, 2024
    • Interventions: Sivelestat (Drug) to Blank control (Drug), Sivelestat (Drug)
    • Site details revised at 2 of 2 sites
    • Collaborators: 1 to 2
    • Study title expanded, about 7 words
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06195267
Lead Sponsor Nanjing Medical University
Collaborators: The First Affiliated Hospital with Nanjing Medical University, Beijing Anzhen Hospital
Conditions
(from sponsor)		 Aortic Dissection, Systemic Inflammatory Response Syndrome, Cardiovascular Diseases (CVD)
Related terms Aortic Dissection, Cardiovascular Diseases, Systemic Inflammatory Response Syndrome
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov