Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
NCT06195267

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

Led by Nanjing Medical University · Updated on 2024-11-22

500

Participants Needed

2

Research Sites

78 weeks

Total Duration

On this page

Sponsors

N

Nanjing Medical University

Lead Sponsor

T

The First Affiliated Hospital with Nanjing Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients meet 2010 ACC/AHA guidelines for thoracic aortic disease diagnosis and treatment within two weeks of onset
  • Patients with type A acute aortic syndrome confirmed clinically and by imaging, planned for emergency surgery
  • Age between 18 and 90 years
  • Agree to participate and sign informed consent
Not Eligible

You will not qualify if you...

  • Allergy to sivelestat sodium
  • Pregnant or breastfeeding women
  • Patients with mental illness or drug and alcohol dependence
  • Refusal to participate or to sign informed consent

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Beijing Anzhen Hospital

Beijing, China

Actively Recruiting

2

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

Nanjing, China

Actively Recruiting

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Research Team

H

Hong Liu, MD

CONTACT

S

Sheng Zhao, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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