Antibacterial Tactics Based on Presepsin Level in Thoracic Aorta Surgery Patients

Changes in Antibacterial Therapy Based on Perioperative Dynamics of Presepsin During Reconstructive Thoracic Aorta Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Thoracic Aortic Aneurysm; Thoracic Aortic Dissection; Cardiac Valve Disease; Aortic Aneurysm and Dissection
• Intervention / Treatment: Drug: Ampicillin-sulbactam

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Artem Gubko, Ph.D.; Phone Number: +79684241490; Email: gubko@artvig.ru
• Study Contact Backup: Name: Boris Akselrod, Professor; Phone Number: +79257403797; Email: aksel@mail.ru

Study Locations

• Russia
  • Moscow
    • Moscow, Moscow, Russia, 119991
      • Recruiting
      • Petrovsky Research National Centre of Surgery (Petrovsky NRCS)
      • Contact: Artem Gubko, Ph.D.; Phone Number: +79684241490; Email: gubko@artvig.ru
      • Sub-Investigator: Denis Guskov, Ph.D
      • Principal Investigator: Boris Akselrod, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Thoracic aorta aneurysm/dissection

Exclusion Criteria:

Blood sample hemolysis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ampicillin/sulbactam intervention group; 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.	Drug: 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.; Other Names: sulmacefta, amibactam
No Intervention: Cefazolin; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infectious complications rate	Postoperative pneumonia, sepsis, wound infection, mediastinitis	up to 10 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Petrovsky National Research Centre of Surgery
• Investigators: Principal Investigator: Boris Akselrod, Professor, Petrovsky NRCS

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2024
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): February 15, 2027

Study Registration Dates

• First Submitted: March 12, 2024
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: cardiac surgery; biomarkers; complications; aortic aneurysm; presepsin; aorta; aortic arch; ascending aorta
• Additional Relevant MeSH Terms: Dissection, Blood Vessel; Acute Aortic Syndrome; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Aortic Diseases; Aneurysm; Dissection, Thoracic Aorta; Aortic Aneurysm; Aortic Dissection; Heart Valve Diseases; Aortic Aneurysm, Thoracic; Anti-Bacterial Agents; Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; beta-Lactamase Inhibitors; sultamicillin
• Other Study ID Numbers: 20240306 (WCG IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No