An interventional study of Ampicillin-sulbactam in Aortic Aneurysm and Dissection, Cardiac Valve Disease and Thoracic Aortic Aneurysm, sponsored by Petrovsky National Research Centre of Surgery. Recruiting at 1 site in Russia. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-29.
Sponsored by Petrovsky National Research Centre of Surgery · Not applicable, Interventional, and Prevention
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.
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.
30 studies on the registry are indexed under Dissection, Thoracic Aorta; 10 are open to participants now.
This study's planned enrollment of 50 is below the median of 87 across 13 interventional studies indexed under Dissection, Thoracic Aorta.
Browse Dissection, Thoracic Aorta studies →Petrovsky National Research Centre of Surgery is the lead sponsor of 18 studies on the registry; 8 are open to participants now.
Compared within Dissection, Thoracic Aorta, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Aortic Dissection. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Thoracic aorta aneurysm/dissection
Exclusion Criteria:
Blood sample hemolysis
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 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
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.
Also known as: sulmacefta, amibactam
Infectious complications rate
Postoperative pneumonia, sepsis, wound infection, mediastinitis
Time frame: up to 10 days
Total amount of complicated patients
Patients that suffer at least 1 complication in postoperative period
Time frame: up to 10 days
Mortality
In-hospital mortality rate
Time frame: up to 10 days
Length of hospital stay
Days spent in hospital since admission
Time frame: up to 10 days
Length of ICU stay
Hours in ICU after the surgery
Time frame: up to 10 days
Multiorgan failure
2 or more organ dysfunction in postoperative period
Time frame: up to 10 days
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2024 (actual). Primary completion is estimated for Dec 2026, 34 months after the start.
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Studies of the drug tested here: Sultamicillin
Petrovsky National Research Centre of Surgery