Additive Anti-inflammatory Action for Aortopathy & Arteriopathy (Sivelestat) VI

Aortic Dissection Clinical Trial

Official title:

Effects of Sivelestat on Inflammatory Response for Acute Aortic Syndrome Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06195267
• Other study ID #: 5A Plan VI
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2023
• Source: Nanjing Medical University
• Contact: Hong Liu, MD
• Phone: +8618801281613
• Email: dr.hongliu[@]foxmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Systemic inflammatory response syndrome (SIRS) and multiple organ dysfunction syndrome (MODS) are the major causes of death in patients with acute aortic syndrome (AAS). 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 AAS will result in a reduced incidence of SIRS and MODS.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Dissection
• Syndrome
• Systemic Inflammatory Response Syndrome

Intervention

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.

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital	Beijing
China	The First Affiliated Hospital of Nanjing Medical University and Jiang ye-fan	Nanjing

Sponsors (2)

Lead Sponsor	Collaborator
Nanjing Medical University	Beijing Anzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	all-cause mortality		30 days after surgery