Antibacterial Tactics Based on Presepsin Level in Thoracic Aorta Surgery Patients

Petrovsky National Research Centre of Surgery

Status: Enrolling

Conditions: Thoracic Aortic Dissection; Thoracic Aortic Aneurysm; Cardiac Valve Disease; Aortic Aneurysm and Dissection

Treatments: Drug: Ampicillin-sulbactam

Study type: Interventional

Funder types: Other

Identifiers

NCT06336213

20240306

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Thoracic aorta aneurysm/dissection

Exclusion criteria

Blood sample hemolysis

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Ampicillin/sulbactam intervention group

Experimental group

Description:

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.

Treatment:

Drug: Ampicillin-sulbactam

Cefazolin

No Intervention group

Description:

If presepsin \< 519,5 pg/ml at the end of surgery, cefazolin 2 g every 6 h at least 72 h p/o is continued further