Clinical trial NCT06336213: Antibacterial Tactics Based on Presepsin Level in Thoracic Aorta Surgery Patients
Official title: Changes in Antibacterial Therapy Based on Perioperative Dynamics of Presepsin During Reconstructive Thoracic Aorta Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Aneurysm and Dissection
Cardiac Valve Disease
Thoracic Aortic Aneurysm
Thoracic Aortic Dissection
Keywords: biomarkers
presepsin
complications
aortic arch
aorta
aortic aneurysm
ascending aorta
cardiac surgery
Lead sponsor: Petrovsky National Research Centre of Surgery
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

Thoracic aorta aneurysm/dissection

Exclusion Criteria:

Blood sample hemolysis

Primary outcomes:
measure: Infectious complications rate
timeFrame: up to 10 days
Secondary outcomes:
measure: Total amount of complicated patients
timeFrame: up to 10 days
measure: Mortality
timeFrame: up to 10 days
measure: Length of hospital stay
timeFrame: up to 10 days
measure: Length of ICU stay
timeFrame: up to 10 days
measure: Multiorgan failure
timeFrame: up to 10 days
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Petrovsky Research National Centre of Surgery (Petrovsky NRCS)
Study officials:
affiliation: Petrovsky NRCS
name: Boris Akselrod, Professor
role: PRINCIPAL_INVESTIGATOR
References: