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NCT Number: NCT06276569

Efficacy and Safety of Sivelestat in Preventing Postoperative Acute Lung Injury or Acute Respiratory Distress Syndrome After Cardiac Surgery

The aim of this study is to assess the effectiveness and safety of sivelestat sodium in preventing acute lung injury and/or acute respiratory distress syndrome (ALI/ARDS) following cardiac surgery, with the objective of providing evidence-based support for its clinical application.

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Key information

Conditions

Cardiac Disease Cardiovascular Diseases Heart Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, China

About this study

This study is being performed as a randomized, placebo-controlled trial conducted in 442 patients who met the inclusion and exclusion criteria and were scheduled for elective cardiac surgery. Following informed consent, patients were randomly assigned to either the experimental group or the control group, with the study drug administered after transfer to the ICU post-surgery. In the experimental group, sivelestat was dissolved in 0.9% sodium chloride injection and diluted with 50ml of the same solution to achieve a dose of 4.8mg/kg/day; this mixture was then placed in a sealed package and administered intravenously at a rate of 0.2 mg/kg/h for seven consecutive days. The control group received an equivalent volume (50ml) of saline continuously administered intravenously at a rate of 0.2 mg/kg/hour. Demographic and clinical information, including admission diagnosis, underlying diseases, medical history, surgical history, details of the surgical procedure, postoperative complications, and in-hospital outcomes were collected from all participants. The primary outcome is the incidence of postoperative ARDS. Secondary outcome measures include data collection on the following parameters: elevated inflammatory response indices (WBC>20×109/L; IL-6>301.88mg/ml; CRP>49.76mg/L; PCT>2.18ng/ml) on postoperative days 1, 3, 5, and 7; APACHE II score; Murray lung injury score; incidence of severe pneumonia; mechanical ventilation-free rate at day 28; mortality rates at both day 28 and day 90. Adverse events such as liver injury, leukopenia, and thrombocytopenia resulting from sivelestat treatment were also monitored. Additionally,during the follow-up period, mortality within a 90-day period will be recorded.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged between 50 and 80 years old.
  • Both sexes.
  • Patients undergoing elective cardiac surgery;informed consent.

Exclusion criteria

  • Patients undergoing emergency surgery.
  • Patients undergoing deep hypothermic circulatory arrest surgery;.
  • Patients with liver and kidney dysfunction (Child-Pugh class B or C, estimated glomerular filtration rate <35 mL/min/1.73 m2).
  • Patients with abnormal baseline inflammatory markers [interleukin-6 (IL6) >10 pg/mL, procalcitonin (PCT) >0.5 ng/mL, C-reactive protein (CRP) >10 mg/L].
  • Patients diagnosed with inflammatory immune disease, infectious disease, or oncological disease; patients receiving other medications that inhibit neutrophil elastase (e.g., ulinastatin, alpha 1-antiprotease).
  • Patients allergic to or intolerant to sodium sivelestat.
  • Pregnant.
  • Patients with prognostic mortality on the European System for Cardiac Surgery Risk Evaluation II (EuroSCORE II) >3% were randomly assigned to either the treatment group or the control group based on the inclusion and exclusion criteria.

Treatment and study plan

Sivelestat

Drug

(1)Experimental group: Received intravenous sivelestat sodium admission to the ICU. Sivelestat sodium was dissolved in 0.9% sodium chloride injection and a one-day dose (4.8mg/kg) was diluted in 50ml of 0.9% sodium chloride injection, which was then sealed for continuous intravenous administration at a rate of 0.2 mg/kg/h for seven consecutive days.

Placebo

Other

2)Control group: Receiving the same dose of placebo, 50 ml of saline, were administered intravenously at a rate of 0.2 mg/kg throughout the treatment period without any discernible impact on patient's regular treatment regimen.

Primary outcomes

  1. Oxygenation index

    Time frame: postoperative day 1, 3, 5 and 7

    SpO2 /FIO2

  2. Inflammatory index

    Time frame: postoperative day 1, 3, 5 and 7

    WBC[×109/L], Neutrophil[NEU,%], Interleukin(IL)-1β[pg/mL], IL-6[pg/mL], IL-8[pg/mL], TNF-α[pg/mL], CRP[mg/L], PCT[ng/mL], neutrophil elastase[NE,ng/mL] and myeloperoxidase[MPO, ng/ml]

  3. Myocardial injury marker

    Time frame: postoperative day 1, 3, 5 and 7

    myoglobin[Myo, ng/ml], CK-MB[ng/ml], hs-cTnI[ng/ml]

  4. Acute physiology and chronic health evaluation(APACHE II) socre

    Time frame: postoperative day 1, 3, 5 and 7

    Interpretation of APACHE II : minimum 0 and maximum 71; increasing score is associated with an increasing risk of hospital death. acute physiology score, chronic health status score, and age adjustment score

  5. Murray socre

    Time frame: postoperative day 1, 3, 5 and 7

    Interpretation of Murray socre : the Murray Lung Injury Score, a clinical assessment tool for evaluating the severity of acute lung injury. The score ranges from 0 to 4, with higher scores indicating worse pulmonary function and more severe lung injury.

  6. ICU time

    Time frame: postoperative 28 days

    Time to stay in the intensive care unit

  7. In-hospital time

    Time frame: postoperative 28 days

    All time during hospitalization

  8. 30-day all-cause mortality

    Time frame: postoperative 30 dayS

    Proportion of deaths caused by various reasons within a certain period of time (30 days) compared to the total number of people in a certain group

  9. 90-day all-cause mortality

    Time frame: postoperative 90 days

    Proportion of deaths caused by various reasons within a certain period of time (90 days) compared to the total number of people in a certain group

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Registry information

Official study title

A Single-center, Randomized, Controlled, Study Evaluating the Efficacy and Safety of Sivelestat Sodium in Preventing Postoperative Acute Lung Injury or Acute Respiratory Distress Syndrome Following Cardiac Surgery

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 26, 2024
Registry last updated
Aug 6, 2025

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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