Antibacterial Tactics Based on Presepsin Level in Thoracic Aorta Surgery Patients

Not Applicable

Recruiting

• Conditions: Aortic Aneurysm and Dissection; Cardiac Valve Disease; Thoracic Aortic Aneurysm; Thoracic Aortic Dissection
• Interventions: Drug: Ampicillin-sulbactam

• Registration Number: NCT06336213
• Lead Sponsor: Petrovsky National Research Centre of Surgery

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 4.15, 95% CI: 1.83-9.41). The combination of two risk factors - a presepsin level at the end of surgery \>519.5 pg/ml 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 5.80, 95% CI: 2. 19-15.35). 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 ampicillin/sulbactam 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 Timeline

• Study Start: 2024-02-19
• Study First Submitted: 2024-03-12
• Study First Submitted QC: 2024-03-21
• Study First Posted: 2024-03-28
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-11-01
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Thoracic aorta aneurysm/dissection

Exclusion Criteria

Blood sample hemolysis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ampicillin/sulbactam intervention group	Ampicillin-sulbactam	If a patient meets dual criteria (presepsin \> 519,5 pg/ml at the end of surgery and the absence of presepsin increase after 6 hours after the end of surgery) then switching to ampicillin/sulbactam 3 g every 6 hours at least 72 h after the surgery is done.

Primary Outcome Measures

Name	Time	Method
Infectious complications rate	up to 10 days	Postoperative pneumonia, sepsis, wound infection, mediastinitis

Secondary Outcome Measures

Name	Time	Method
Mortality	up to 10 days	In-hospital mortality rate
Total amount of complicated patients	up to 10 days	Patients that suffer at least 1 complication in postoperative period
Length of hospital stay	up to 10 days	Days spent in hospital since admission
Length of ICU stay	up to 10 days	Hours in ICU after the surgery
Multiorgan failure	up to 10 days	2 or more organ dysfunction in postoperative period

Trial Locations

Locations (1)

Petrovsky Research National Centre of Surgery (Petrovsky NRCS); 🇷🇺 Moscow, Russian Federation