Viewing Study NCT06336213



Ignite Creation Date: 2024-05-06 @ 8:19 PM
Last Modification Date: 2024-10-26 @ 3:25 PM
Study NCT ID: NCT06336213
Status: RECRUITING
Last Update Posted: 2024-03-28
First Post: 2024-03-12

Brief Title: Antibacterial Tactics Based on Presepsin Level in Thoracic Aorta Surgery Patients
Sponsor: Petrovsky National Research Centre of Surgery
Organization: Petrovsky National Research Centre of Surgery

Study Overview

Official Title: Changes in Antibacterial Therapy Based on Perioperative Dynamics of Presepsin During Reconstructive Thoracic Aorta Surgery
Status: RECRUITING
Status Verified Date: 2024-03
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: According to the literature presepsin was recommended not only as an effective indicator in the diagnosis of sepsis in intensive care units but also as a reliable prognostic marker of postoperative inflammatory processes in cardiac surgery Previous study carried out in Petrovsky NRCS related to biomarkers in cardiac surgery and presepsin in particular showed good sensitivity in infection complications prognosis
Detailed Description: Various biomarkers are being used to improve the quality of prediction models aiming to improve clinical outcomes and reduce mortality in the cardiac surgery patient population In particular presepsin and procalcitonin have comparable prognostic value for adverse renal cardiovascular and respiratory outcomes in cardiac surgery patients In addition presepsin has in-hospital 30-day and 6-month prognostic mortality rate value and is also highly effective for the early diagnosis of sepsis in patients in the intensive care unit In the previous study the absence of an increase in the level of presepsin in the first 6 hours after surgery was associated with an increased risk of developing a complicated course of the postoperative period OR 415 95 CI 183-941 The combination of two risk factors - a presepsin level at the end of surgery 5195 pgml and the absence of an increase in the presepsin level in the first 6 hours after surgery was associated with an increased risk of developing a complicated course of the postoperative period OR 580 95 CI 2 19-1535 The hypothesis of this study suggests that in case of insufficient prevention of infectious complications based on the dynamics of presepsin it is permissible to administer the broad-spectrum drug ampicillinsulbactam 3 g every 6 hours for at least 72 hours from the date of surgery It is expected that changes in the tactics of antibacterial therapy will reduce the number of inflammatory complications in patients undergoing surgery on thoracic aorta

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?: None
Is an FDA AA801 Violation?: None