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NCT Number: NCT06195267

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

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.

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Key information

Conditions

Aortic Dissection Acute Aortic Syndrome Aneurysm Aortic Diseases Cardiovascular Diseases Cardiovascular Diseases (CVD) Dissection, Blood Vessel Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Systemic Inflammatory Response Syndrome Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Anzhen Hospital, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Blank control

Drug

Patients only received standard treatment and care.

Primary outcomes

  1. The highest SOFA score of 7 days after surgery

    Time frame: 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 outcomes

  1. all-cause mortality

    Time frame: 30 days after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Hong Liu, MD

CONTACT

[email protected]

+8618801281613

Sheng Zhao, MD

CONTACT

[email protected]

02568303105

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Collaborators

  • Beijing Anzhen Hospital
  • The First Affiliated Hospital with Nanjing Medical University

Registry information

Acronym: PANDA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 8, 2024
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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