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

Launched by NANJING MEDICAL UNIVERSITY · Dec 23, 2023

Keywords

ClinConnect Summary

The PANDA VI clinical trial is studying a medication called sivelestat to see if it can help prevent serious complications after heart surgery, especially in patients with conditions like aortic dissection and systemic inflammatory response syndrome (SIRS). These complications can lead to organ dysfunction, which is a major concern for patients undergoing cardiovascular surgeries. The researchers believe that giving sivelestat during the early stages of treatment could lower the chances of these complications occurring.

To participate in this trial, individuals need to be between 18 and 90 years old and have been diagnosed with certain types of aortic conditions within two weeks of their symptoms starting. They must also agree to take part in the study and sign a consent form. Those who are allergic to sivelestat, pregnant or breastfeeding, or have certain mental health issues cannot join. Participants will receive the medication and be monitored closely to see how it affects their health after surgery. This study is currently in the recruitment phase, meaning they are looking for eligible patients to enroll.

Gender

ALL

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.