Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06276569
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-28
First Post:
2024-01-31
Brief Title:
Efficacy and Safety of Sivelestat in Preventing Postoperative Acute Respiratory Distress Syndrome After Cardiac Surgery a Single Centre Random Control Trial
Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Organization:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study Overview
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
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 09 sodium chloride injection and diluted with 50ml of the same solution to achieve a dose of 48mgkgday this mixture was then placed in a sealed package and administered intravenously at a rate of 02 mgkgh for seven consecutive days The control group received an equivalent volume 50ml of saline continuously administered intravenously at a rate of 02 mgkghour 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 WBC20109L IL-630188mgml CRP4976mgL PCT218ngml 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 Additionallyduring the follow-up period mortality within a 90-day period will be recorded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None