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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorNanjing Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: SivelestatExperimental treatment 1 intervention
Group B: Blank controlSham comparator 1 intervention

Trial outcomes

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).

Time frame
7 days after surgery

Secondary outcomes

1

all-cause mortality

Time frame
30 days after surgery

Other outcomes

Sponsors and contacts

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Nanjing Medical University

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Collaborator

Beijing Anzhen Hospital

Collaborator