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RECRUITING
NCT06028789

AOrtic Surgery: Systemic Inflammatory Response Versus Sepsis

Sponsor: University Hospital Hradec Kralove

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

OBSERVATIONAL

Enrollment

60

Start Date

2022-04-01

Completion Date

2024-06-30

Last Updated

2024-05-21

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Blood 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)

PROCEDURE

Thoracic 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