Aortic Dissection, Systemic Inflammatory Response Syndrome, Cardiovascular Diseases (CVD)
Conditions
Keywords
Systemic Inflammatory Response Syndrome
Brief 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.
Interventions
DRUGSivelestat
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.
DRUGBlank control
Patients only received standard treatment and care.
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Beijing Anzhen Hospital
Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The highest SOFA score of 7 days after surgery | 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
| Measure | Time frame |
|---|---|
| all-cause mortality | 30 days after surgery |
Countries
China
Contacts
Primary ContactHong Liu, MD
Backup ContactSheng Zhao, MD
Outcome results
None listed