Protective Effect of Ulinastatin Against Negative Inflammatory Response and Organ Dysfunction After Acute Type a Aortic Dissection Surgery (PANDA I)

Not Applicable

Completed

• Conditions: Acute Aortic Syndrome; Type a Aortic Dissection
• Interventions: Drug: Ulinastatin; Drug: Blank control

• Registration Number: NCT04711889
• Lead Sponsor: Nanjing Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-01-13
• Study First Submitted QC: 2021-01-13
• Study First Posted: 2021-01-15
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ulinastatin	Ulinastatin	Ulinastatin 10 0000 Units is taken intravenously three times a day.
Blank control	Blank control	Blank control.

Primary Outcome Measures

Name	Time	Method
SOFA score	mean SOFA score 7 days after surgery	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)

Secondary Outcome Measures

Name	Time	Method
Mortality	30 days after surgery	Death from any cause

Trial Locations

Locations (2)

The first affiliated hospital of nanjing medical university; 🇨🇳 Nanjing, Jiangsu, China

Beijing Anzhen Hospital; 🇨🇳 Beijing, China