Protective Effect of Sivelestat Against Negative Pulmonary Function and Organ Dysfunction After Cardiovascular Surgery (PANDA VI)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sivelestat, Blank control.
- Who it may be relevant to
- Registry conditions: Aortic Dissection, Systemic Inflammatory Response Syndrome, Cardiovascular Diseases (CVD). Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Drug Sivelestat
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. - Drug Blank control
Patients only received standard treatment and care.
Primary outcome measures
- The highest SOFA score of 7 days after surgery [Time frame: 7 days after surgery]
Secondary outcome measures (1)
- all-cause mortality [Time frame: 30 days after surgery]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Beijing Anzhen Hospital — Beijing
- The First Affiliated Hospital of Nanjing Medical University and Jiang ye-fan — Nanjing
Identifiers
NCT: NCT06195267 · PANDA VI