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

Nanjing Medical University

Status: Enrolling

Conditions: Systemic Inflammatory Response Syndrome; Cardiovascular Diseases (CVD); Aortic Dissection

Treatments: Drug: Blank control; Drug: Sivelestat

Study type: Interventional

Funder types: Other

Identifiers

NCT06195267

PANDA VI

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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500 participants in 2 patient groups

Sivelestat

Experimental group

Treatment:

Drug: Sivelestat

Blank control

Sham Comparator group

Description:

The control group did not receive any intervention.

Treatment:

Drug: Blank control