Additive Anti-inflammatory Action for Aortopathy & Arteriopathy (Ulinastatin) II

Acute Aortic Syndrome Clinical Trial

Official title:

Effects of Ulinastatin on Inflammatory Response for Acute Aortic Syndrome Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04711889
• Other study ID #: 5A-Plan II
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: January 2024
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Acute Aortic Syndrome (AAS) is a common feature of acute aortic wall events, including aortic dissection, intramural hematoma, aortic ulceration and aortic trauma, and occurs in up to 35 cases per 100,000 cases per year between the ages of 65 and 75 years. Ulinastatin has antiinflammatory activity and suppresses the infiltration of neutrophils and the release of elastase and chemical mediators from neutrophils. Recent studies have shown that ulinastatin may be cytoprotective against ischemia-reperfusion injury in the liver, kidney, heart, and lung. The authors aim to examine the association between decreased release of inflammatory response to urinary trypsin inhibitor treatment and decreased myocardial and lung injury after acute aortic syndrome surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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 aortic surgery were enrolled.
• The patients' age of 18 years or older.
• Agree to participate in the study and sign the informed consent.

Exclusion Criteria:

• Patients allergic to Ulinastatin;
• Lactating women and pregnant women;
• Patients with mental diseases;
• Refuse to participate in this study and refuse to sign the informed consent.

Related Conditions & MeSH terms

• Acute Aortic Syndrome
• Aortic Dissection
• Syndrome
• Type A Aortic Dissection

Intervention

Drug:
• Ulinastatin
Ulinastatin is taken three times a day.
• Blank control
Blank control

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital	Beijing
China	The first affiliated hospital of nanjing medical university	Nanjing	Jiangsu

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	SOFA score	The daily SOFA score after baseline was calculated for each patient on the basis of organ systems: neurologic, 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)	mean SOFA score 7 days after surgery
Secondary	Mortality	Death from any cause	30 days after surgery