Petrovsky Research National Centre of Surgery (Petrovsky NRCS)
Moscow, 119991, Russia
Location status: Recruiting
Location contact
Artem Gubko, Ph.D.
CONTACT
Boris Akselrod, Ph.D
PRINCIPAL_INVESTIGATOR
Denis Guskov, Ph.D
SUB_INVESTIGATOR
NCT Number: NCT06336213
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Moscow, 119991, Russia
Location status: Recruiting
Artem Gubko, Ph.D.
CONTACT
Boris Akselrod, Ph.D
PRINCIPAL_INVESTIGATOR
Denis Guskov, Ph.D
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Other names: sulmacefta, amibactam
Time frame: up to 10 days
Postoperative pneumonia, sepsis, wound infection, mediastinitis
Time frame: up to 10 days
Patients that suffer at least 1 complication in postoperative period
Time frame: up to 10 days
In-hospital mortality rate
Time frame: up to 10 days
Days spent in hospital since admission
Time frame: up to 10 days
Hours in ICU after the surgery
Time frame: up to 10 days
2 or more organ dysfunction in postoperative period
Contact information is provided by the study sponsor or research team.
Artem Gubko, Ph.D.
CONTACT
Boris Akselrod, Professor
CONTACT
Petrovsky National Research Centre of Surgery
Other
Changes in Antibacterial Therapy Based on Perioperative Dynamics of Presepsin During Reconstructive Thoracic Aorta Surgery
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