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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorNanjing Medical University

About this trial

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.

Eligibility criteria

Qualifiers

The patients are conformed to 2010 ACC/AHA guidelines for the diagnosis and treatment of thoracic aortic disease (TAD) within two weeks of onset;

Patients with type A acute aortic syndrome confirmed clinically and radiologically and planning to undergo emergency surgery were enrolled.

The patients' age between 18 ~90 years old.

Agree to participate in the study and sign the informed consent.

Disqualifiers

Patients allergic to sivelestat sodium;

Lactating women and pregnant women;

Patients with mental diseases, drug and alcohol dependence;

Refuse to participate in this study and refuse to sign the informed consent.

Trial design

Treatments tested in this trial

  • Sivelestat
  • Blank control

Treatment groups

500 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Nanjing Medical University

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Collaborator

Beijing Anzhen Hospital

Collaborator