Protective Effect of Sivelestat Against Negative Pulmonary Function and Organ Dysfunction After Cardiovascular Surgery (PANDA VI)

Not Applicable

Recruiting

• Conditions: Aortic Dissection; Systemic Inflammatory Response Syndrome; Cardiovascular Diseases (CVD)
• Interventions: Drug: Sivelestat; Drug: Blank control

• Registration Number: NCT06195267
• Lead Sponsor: Nanjing Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-23
• Study First Submitted QC: 2023-12-23
• Study First Posted: 2024-01-08
• Study Start: 2024-07-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sivelestat	Sivelestat	-
Blank control	Blank control	The control group did not receive any intervention.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
all-cause mortality	30 days after surgery

Trial Locations

Locations (2)

Beijing Anzhen Hospital; 🇨🇳 Beijing, China

The First Affiliated Hospital of Nanjing Medical University and Jiang ye-fan; 🇨🇳 Nanjing, China