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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
500
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.
Beijing Anzhen Hospital
Beijing, China
RECRUITINGThe First Affiliated Hospital of Nanjing Medical University and Jiang ye-fan
Nanjing, China
RECRUITINGThe 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).
Time frame: 7 days after surgery
all-cause mortality
Time frame: 30 days after surgery
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