Using sivelestat to protect lung function after heart surgery
Official title: Protective Effect of Sivelestat Against Negative Pulmonary Function and Organ Dysfunction After Cardiovascular Surgery (PANDA VI)
Run by Nanjing Medical University · NCT06195267 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Nanjing Medical University Academic / other |
| Locations | 2 sites (Beijing and 1 other locations) |
| Status | Recruiting |
| Started | July 1, 2024 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | November 22, 2024 |
| Trial ID | NCT06195267 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 90 diagnosed with type A acute aortic syndrome who are planning to undergo emergency surgery.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
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
- Email: dr.hongliu@foxmail.com
- Phone: +8618801281613
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.