AOrtic Surgery: Systemic Inflammatory Response Versus Sepsis

NCT06028789 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2024-05-21

No results posted yet for this study

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.

Conditions

  • Systemic Inflammatory Response Syndrome
  • Infections
  • Thoracic Aortic Aneurysm
  • Aortic Diseases
  • Immunological Abnormality

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.

Sponsors & Collaborators

  • American Association for Thoracic Surgery

    collaborator UNKNOWN
  • University Hospital Hradec Kralove

    lead OTHER

Principal Investigators

  • Jan Vojacek, Prof. MD · University Hospital Hradec Kralove

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • Czechia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06028789 on ClinicalTrials.gov