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

NCT06195267 | Recruiting DMC

• 1 other identifier: PANDA VI
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 2

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.

Conditions

Aortic Dissection; Systemic Inflammatory Response Syndrome; Cardiovascular Diseases (CVD)

Keywords

Systemic Inflammatory Response Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• all-cause mortality

  30 days after surgery

Study Arms (2)

Sivelestat

EXPERIMENTAL

Drug: Sivelestat

Blank control

SHAM COMPARATOR

The control group did not receive any intervention.

Drug: Blank control

Interventions

Sivelestat DRUG

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.

Sivelestat

Blank control DRUG

Patients only received standard treatment and care.

Blank control

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing Medical University: lead
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Beijing Anzhen Hospital: collaborator

Study Sites (2)

Beijing Anzhen Hospital

Beijing, China

RECRUITING

The First Affiliated Hospital of Nanjing Medical University and Jiang ye-fan

Nanjing, China

RECRUITING

MeSH Terms

Conditions

Aortic Dissection; Systemic Inflammatory Response Syndrome; Cardiovascular Diseases

Interventions

sivelestat

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Acute Aortic Syndrome; Aortic Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Central Study Contacts

Hong Liu, MD

CONTACT

+8618801281613; dr.hongliu@foxmail.com

Sheng Zhao, MD

CONTACT

02568303105; zhaosheng0824@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator of Cardiovascular Surgery

Study Record Dates

• First Submitted: December 23, 2023
• First Posted: January 8, 2024
• Study Start: July 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 22, 2024

Record last verified: 2024-11

Locations

CN (2)