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

Cardiac Disease Clinical Trial

Official title: A Single-center, Randomized, Controlled, Single-blind Study Evaluating the Efficacy and Safety of Sivelestat Sodium in Preventing Postoperative Acute Respiratory Distress Syndrome Following Cardiac Surgery

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Acute Lung Injury
• Cardiac Disease
• Heart Diseases
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

• NCT number: NCT06276569
• Study type: Interventional
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: February 18, 2024
• Completion date: December 31, 2026