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| Name | Class |
|---|---|
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
| Beijing Anzhen Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sivelestat | Experimental |
| |
| Blank control | Sham Comparator | The control group did not receive any intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sivelestat | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 7 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| all-cause mortality | 30 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hong Liu, MD | Contact | +8618801281613 | dr.hongliu@foxmail.com | |
| Sheng Zhao, MD | Contact | 02568303105 | zhaosheng0824@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital | Recruiting | Beijing | China |
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| Blank control | Drug | Patients only received standard treatment and care. |
|
| The First Affiliated Hospital of Nanjing Medical University and Jiang ye-fan | Recruiting | Nanjing | China |
|
| ID | Term |
|---|---|
| D000784 | Aortic Dissection |
| D018746 | Systemic Inflammatory Response Syndrome |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D000094665 | Dissection, Blood Vessel |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D000094683 | Acute Aortic Syndrome |
| D001018 | Aortic Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
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| ID | Term |
|---|---|
| C069195 | sivelestat |
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