About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Sivelestat
DrugThe 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.
Blank control
DrugPatients only received standard treatment and care.
Treatment groups
Trial outcomes
Primary outcomes
The highest SOFA score of 7 days after surgery
The daily SOFA score after baseline was calculated for each patient on the basis of five organ systems: cardiovascular, respiratory, renal, hepatic, and coagulation systems. (Scores for each system range from 0 to 4, with higher scores indicating more severe organ-system dysfunction).
Secondary outcomes
all-cause mortality
Sponsors and contacts
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Nanjing Medical University
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborator
Beijing Anzhen Hospital
Collaborator