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Antibacterial Tactics Based on Presepsin Level in Thoracic Aorta Surgery Patients

ConditionsAortic Aneurysm and DissectionCardiac Valve DiseaseThoracic Aortic AneurysmThoracic Aortic Dissection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPetrovsky National Research Centre of Surgery

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ampicillin-sulbactam

    Drug

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Ampicillin/sulbactam intervention groupExperimental treatment 1 intervention
Group B: CefazolinNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Infectious complications rate

Postoperative pneumonia, sepsis, wound infection, mediastinitis

Time frame
up to 10 days

Secondary outcomes

1

Total amount of complicated patients

Patients that suffer at least 1 complication in postoperative period

Time frame
up to 10 days
2

Mortality

In-hospital mortality rate

Time frame
up to 10 days
3

Length of hospital stay

Days spent in hospital since admission

Time frame
up to 10 days
4

Length of ICU stay

Hours in ICU after the surgery

Time frame
up to 10 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Petrovsky National Research Centre of Surgery

Lead sponsor

Source ClinicalTrials.gov
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