Antibacterial Tactics Based on Presepsin Level in Thoracic Aorta Surgery Patients

Thoracic Aortic Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06336213
• Other study ID #: 20240306
• Status: Recruiting
• Phase: N/A
• Start date: February 19, 2024
• Est. completion date: December 15, 2024

Study information

• Verified date: March 2024
• Source: Petrovsky National Research Centre of Surgery
• Contact: Artem Gubko, Ph.D.
• Phone: +79684241490
• Email: gubko[@]artvig.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 15, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

Thoracic aorta aneurysm/dissection

Exclusion Criteria:

Blood sample hemolysis

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm and Dissection
• Aortic Aneurysm, Thoracic
• Aortic Dissection
• Cardiac Valve Disease
• Heart Valve Diseases
• Thoracic Aortic Aneurysm
• Thoracic Aortic Dissection

Intervention

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.

Locations

Country	Name	City	State
Russian Federation	Petrovsky Research National Centre of Surgery (Petrovsky NRCS)	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Petrovsky National Research Centre of Surgery

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infectious complications rate	Postoperative pneumonia, sepsis, wound infection, mediastinitis	up to 10 days
Secondary	Total amount of complicated patients	Patients that suffer at least 1 complication in postoperative period	up to 10 days
Secondary	Mortality	In-hospital mortality rate	up to 10 days
Secondary	Length of hospital stay	Days spent in hospital since admission	up to 10 days
Secondary	Length of ICU stay	Hours in ICU after the surgery	up to 10 days
Secondary	Multiorgan failure	2 or more organ dysfunction in postoperative period	up to 10 days