Using sivelestat to protect lung function after heart surgery

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

This study is testing if giving sivelestat to patients having emergency heart surgery can help protect their lungs and improve recovery by reducing serious complications.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 500 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Nanjing Medical University (other)
• Locations: 2 sites (Beijing and 1 other locations)
• Trial ID: NCT06195267 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the protective effects of sivelestat, an immunomodulatory therapy, on patients undergoing cardiovascular surgery. It aims to determine whether administering sivelestat during the acute phase of cardiovascular diseases can reduce the incidence of systemic inflammatory response syndrome (SIRS) and multiple organ dysfunction syndrome (MODS). The study will enroll patients diagnosed with type A acute aortic syndrome who are scheduled for emergency surgery, comparing outcomes between those receiving sivelestat and a control group. The trial is designed to provide insights into the potential benefits of sivelestat in improving postoperative recovery.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 90 diagnosed with type A acute aortic syndrome who are planning to undergo emergency surgery.

Not a fit: Patients with allergies to sivelestat, pregnant or lactating women, and those with mental health issues or substance dependence may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce complications and improve recovery outcomes for patients undergoing cardiovascular surgery.

How similar studies have performed: While the specific use of sivelestat in this context may be novel, similar immunomodulatory approaches have shown promise in managing SIRS and MODS in other studies.

Eligibility criteria

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.

Where this trial is running

Beijing and 1 other locations

• Beijing Anzhen Hospital — Beijing, China (RECRUITING)
• The First Affiliated Hospital of Nanjing Medical University and Jiang ye-fan — Nanjing, China (RECRUITING)

Study contacts

• Study coordinator: Hong Liu, MD

Conditions: Aortic Dissection, Systemic Inflammatory Response Syndrome, Cardiovascular Diseases