Actively Recruiting
Changes in Antibacterial Therapy Based on Perioperative Dynamics of Presepsin During Reconstructive Thoracic Aorta Surgery
Led by Petrovsky National Research Centre of Surgery · Updated on 2026-01-29
50
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring the use of presepsin, a biomarker valuable for diagnosing sepsis and predicting postoperative inflammatory complications, in patients undergoing thoracic aorta surgery. This study aims to improve antibacterial therapy decisions based on presepsin levels to reduce infection-related complications after surgery. Previous findings suggest presepsin levels can indicate risks for adverse outcomes during the postoperative period in cardiac surgery patients. Participants undergo reconstructive thoracic aorta surgery and are monitored for presepsin levels at the end of surgery and six hours afterward. Those meeting specific criteria—presepsin above 519.5 pg/ml at surgery end and no increase after six hours—may switch to an antibacterial treatment with ampicillin/sulbactam 3 g every six hours for at least 72 hours. Patients with presepsin below this threshold continue on cefazolin 2 g every six hours for a minimum of 72 hours postoperatively. During the study, participants are observed for up to 10 days to track infectious complication rates, mortality, length of hospital and ICU stays, multiorgan failure, and the total number of patients with complicated courses. The study evaluates how adjusting antibacterial therapy based on presepsin dynamics may impact these outcomes, with close monitoring to assess safety and effectiveness throughout the postoperative period.
CONDITIONS
Brief Title
Antibacterial Tactics Based on Presepsin Level in Thoracic Aorta Surgery Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of thoracic aorta aneurysm or dissection
- Age between 18 and 75 years
You will not qualify if you...
- Blood sample hemolysis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Hospital stay including surgery and first 6 hours after surgery
Participants undergo reconstructive thoracic aorta surgery followed by immediate post-operative monitoring including presepsin level assessments to determine antibacterial therapy.
Continuous monitoring during hospital stay
Duration - At least 72 hours after surgery
Participants receive antibacterial therapy based on presepsin levels: either ampicillin/sulbactam 3 g every 6 hours or cefazolin 2 g every 6 hours for at least 72 hours after surgery.
Multiple daily doses during hospitalization
Duration - Up to 10 days post surgery
Participants are monitored for infectious complications, organ function, and recovery outcomes up to 10 days post surgery.
Daily assessments during hospital stay
Trial Site Locations
Total: 1 location
1
Petrovsky Research National Centre of Surgery (Petrovsky NRCS)
Moscow, Moscow, Russia, 119991
Actively Recruiting
Research Team
A
Artem Gubko, Ph.D.
B
Boris Akselrod, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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