RecruitingNCT06028789

AOrtic Surgery: Systemic Inflammatory Response Versus Sepsis

Differential Diagnosis of Sterile Systemic Inflammation and Sepsis in Patients Undergoing Thoracic Aortic Surgery


Sponsor

University Hospital Hradec Kralove

Enrollment

60 participants

Start Date

Apr 1, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

The goal of the prospective observational study is to evaluate the immunological background of inflammatory response often seen after open thoracic aortic surgery. Patients scheduled for this type of procedure will undergo a series of blood testing (preoperatively, and several times postoperatively). The blood samples will be used for a wide scale of immunological tests to better evaluate potential differential markers against infection. A control group will include patients with active infective endocarditis (preoperatively). The main question is if there is a biomarker able to determine a difference between sterile systemic inflammation and infection after thoracic aortic surgery. The second question is if there is a difference in dynamics of evaluated biomarkers between sterile postoperative inflammation and active endocarditis.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria4

  • patient scheduled for elective replacement of thoracic aorta of any extent by artificial vascular graft, including Bentall procedure, Yacoub procedure, supracoronary aortic replacement, also Ross procedure with supracoronary aortic replacement, hemiarch and total aortic arch replacement
  • signature of informed patient consent
  • patient with active infectious endocarditis
  • signature of informed patient consent

Exclusion Criteria3

  • active endocarditis or other infection
  • unstable preoperative condition
  • more than 5 days since diagnosis

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Interventions

DIAGNOSTIC_TESTBlood sample test

The following groups of biomarkers will be examined: * standard panel of inflammation markers: CRP, PCT, IL-6, Leukocyte count, differential blood count * microbiology cultures according to the clinical status * serum biomarkers: sCD64, sTREM-1, calprotectin, pentraxin 3 * flow cytometry: HLA-DR, CD14, CD16, CD40, CD45, CD64, CD163 expression on granulocytes and monocytes * cell function assay: IL-18 and IFN-γ * hematology: ICIS, Neutrophil-to-lymphocyte ratio - examined together with conventional hematological parameters. The schedule of blood sample taking will be as follows: A. the study group: preoperatively (T-1), 1st postoperative day (T1), 3rd postoperative day (T2), 7th postoperative day (T3), 10th postoperative day (T4) B. the control group: at admission or the next day (T1), 3rd day of hospital stay (T2), 7th day of hospital stay (T3), 10th day of hospital stay (T4)

PROCEDUREThoracic Aortic Surgery

Scheduled surgical intervention, i.e. replacement of pre-specified part of thoracic aorta by a vascular prosthesis.


Locations(1)

University Hospital Hradec Králové

Hradec Králové, Královehradecký Kraj, Czechia

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NCT06028789


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