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Clinical trial

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

ID
Name
20240306
Description
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.
Trial arms
Trial start
2024-02-19
Estimated PCD
2024-11-01
Trial end
2024-12-15
Status
Recruiting
Treatment
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.
Arms:
Ampicillin/sulbactam intervention group
Other names:
sulmacefta, amibactam
Size
50
Primary endpoint
Infectious complications rate
up to 10 days
Eligibility criteria
Inclusion Criteria: Thoracic aorta aneurysm/dissection Exclusion Criteria: Blood sample hemolysis
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2024-03-28

1 organization

1 product

4 indications

Organization
Petrovsky National Research Centre of Surgery
Product
Ampicillin-sulbactam
Indication
Aortic Aneurysm and Dissection
Indication
Valvular Heart Disease
Indication
Thoracic Aortic Aneurysm
Indication
Aortic Dissection