Efficacy and Safety of Sivelestat in Preventing Postoperative Acute Respiratory Distress Syndrome After Cardiac Surgery :a Single Centre Random Control Trial.

Last updated: February 26, 2024
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Overall Status: Active - Not Recruiting

Phase

3

Condition

Lung Injury

Cardiac Disease

Acute Respiratory Distress Syndrome (Ards)

Treatment

Sivelestat

placebo

Clinical Study ID

NCT06276569
2023-LCYJ-MS-26
  • Ages 50-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  1. Patients undergoing emergency surgery.
  2. Patients undergoing deep hypothermic circulatory arrest surgery;.
  3. Patients with liver and kidney dysfunction (Child-Pugh class B or C, estimatedglomerular filtration rate <35 mL/min/1.73 m2).
  4. 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].
  5. Patients diagnosed with inflammatory immune disease, infectious disease, oroncological disease; patients receiving other medications that inhibit neutrophilelastase (e.g., ulinastatin, alpha 1-antiprotease).
  6. Patients allergic to or intolerant to sodium sivelestat.
  7. Pregnant.
  8. Patients with prognostic mortality on the European System for Cardiac Surgery RiskEvaluation II (EuroSCORE II) >3% were randomly assigned to either the treatment groupor the control group based on the inclusion and exclusion criteria.

Study Design

Total Participants: 384
Treatment Group(s): 2
Primary Treatment: Sivelestat
Phase: 3
Study Start date:
February 18, 2024
Estimated Completion Date:
December 31, 2026

Study Description

This study is being performed as a randomized, single-blind, placebo-controlled trial conducted in 384 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 drug administration occurring within 6 hours 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.