Protective Effect of Sivelestat Against Negative Pulmonary Function and Organ Dysfunction After Cardiovascular Surgery (PANDA VI)
Nanjing Medical University
500 participants
Jul 1, 2024
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria4
- 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 Criteria4
- 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.
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Interventions
The total 24-hour dose of Sivelestat sodium (4.8mg/kg) was dissolved with 50 ml normal saline. The drug flow rate was set at 2ml/h with an intravenous microinfusion pump, and the constant speed infusion was completed in 24h.
Patients only received standard treatment and care.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06195267