AOrtic Surgery: Systemic Inflammatory Response Versus Sepsis

NCT06028789 | Recruiting

• 1 other identifier: 202202 P02
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

systemic inflammatory response syndrome; infection; thoracic aortic surgery

Outcome Measures

Primary Outcomes (3)

• Serum concentration of sCD64

  A statistically significant difference in absolute value or dynamics of serum concentrations of sCD64 between the study groups to help distinguish between the specified clinical syndromes.

  After completion of the study - until the end of 2023

• Expression of CD64 on granulocytes

  A statistically significant difference in absolute values or dynamics of the expression of CD64 on granulocytes between the study groups to distinguish between the specified clinical syndromes. Expression on monocytes will be also assessed.

  After completion of the study - until the end of 2023

• Cell function assay of INF-γ

  A significant difference in the outcomes of cell function assay of INF-γ between the study groups to distinguish between the specified clinical syndromes.

  After completion of the study - until the end of 2023

Secondary Outcomes (11)

• Serum concentration of sTREM-1

  After completion of the study - until the end of 2023

• Serum concentration of calprotectin

  After completion of the study - until the end of 2023

• Serum concentration of pentraxin 3

  After completion of the study - until the end of 2023

• Expression of HLA-DR on granulocytes

  After completion of the study - until the end of 2023

• Expression of CD-14 on granulocytes

  After completion of the study - until the end of 2023

Other Outcomes (5)

• Serum concentration of C-Reactive protein

  After completion of the study - until the end of 2023

• Serum concentration of procalcitonin

  After completion of the study - until the end of 2023

• Serum concentration of IL-6

  After completion of the study - until the end of 2023

Study Arms (2)

Study group

Patients undergoing elective thoracic aortic surgery.

Diagnostic Test: Blood sample test; Procedure: Thoracic Aortic Surgery

Control group

Patients admitted to our institution with active infectious endocarditis.

Diagnostic Test: Blood sample test

Interventions

Blood sample test DIAGNOSTIC_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)

Control group; Study group

Thoracic Aortic Surgery PROCEDURE

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

Study group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study group is defined as patients scheduled for elective replacement of thoracic aorta of any extent by artificial vascular graft, including Bentall procedure,valve-sparing root replacement, supracoronary aortic replacement, also Ross procedure with supracoronary aortic replacement, hemiarch and total aortic arch replacement. Control group is defined as patients admitted to our institution with active infectious endocarditis.

You may qualify if:

• 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

You may not qualify if:

• active endocarditis or other infection
• unstable preoperative condition
• patient with active infectious endocarditis
• signature of informed patient consent
• more than 5 days since diagnosis

Sponsors & Collaborators

• University Hospital Hradec Kralove: lead
• American Association for Thoracic Surgery: collaborator

Study Sites (1)

University Hospital Hradec Králové

Hradec Králové, Královehradecký Kraj, 500 02, Czechia

RECRUITING

Related Publications (8)

• Gabaldo K, Sutlic Z, Miskovic D, Knezevic Pravecek M, Prvulovic D, Vujeva B, Cvitkusic Lukenda K, Hadzibegovic I. Postpericardiotomy syndrome incidence, diagnostic and treatment strategies: experience AT two collaborative centers. Acta Clin Croat. 2019 Mar;58(1):57-62. doi: 10.20471/acc.2019.58.01.08.

  PMID: 31363326 BACKGROUND

• Daye D, Walker TG. Complications of endovascular aneurysm repair of the thoracic and abdominal aorta: evaluation and management. Cardiovasc Diagn Ther. 2018 Apr;8(Suppl 1):S138-S156. doi: 10.21037/cdt.2017.09.17.

  PMID: 29850426 BACKGROUND

• Raveendran AV, Kumar A, Gangadharan S. Biomarkers and newer laboratory investigations in the diagnosis of sepsis. J R Coll Physicians Edinb. 2019 Sep;49(3):207-216. doi: 10.4997/JRCPE.2019.308.

  PMID: 31497788 BACKGROUND

• Gibot S, Bene MC, Noel R, Massin F, Guy J, Cravoisy A, Barraud D, De Carvalho Bittencourt M, Quenot JP, Bollaert PE, Faure G, Charles PE. Combination biomarkers to diagnose sepsis in the critically ill patient. Am J Respir Crit Care Med. 2012 Jul 1;186(1):65-71. doi: 10.1164/rccm.201201-0037OC. Epub 2012 Apr 26.

  PMID: 22538802 BACKGROUND

• Nierhaus A, Linssen J, Wichmann D, Braune S, Kluge S. Use of a weighted, automated analysis of the differential blood count to differentiate sepsis from non-infectious systemic inflammation: the intensive care infection score (ICIS). Inflamm Allergy Drug Targets. 2012 Apr;11(2):109-15. doi: 10.2174/187152812800392841.

  PMID: 22280231 BACKGROUND

• Kofoed K, Andersen O, Kronborg G, Tvede M, Petersen J, Eugen-Olsen J, Larsen K. Use of plasma C-reactive protein, procalcitonin, neutrophils, macrophage migration inhibitory factor, soluble urokinase-type plasminogen activator receptor, and soluble triggering receptor expressed on myeloid cells-1 in combination to diagnose infections: a prospective study. Crit Care. 2007;11(2):R38. doi: 10.1186/cc5723.

  PMID: 17362525 BACKGROUND

• Djebara S, Biston P, Fosse E, Daper A, Joris M, Boudjeltia KZ, Lelubre C, Cauchie P, Piagnerelli M. Time Course of CD64, a Leukocyte Activation Marker, During Cardiopulmonary Bypass Surgery. Shock. 2017 Feb;47(2):158-164. doi: 10.1097/SHK.0000000000000751.

  PMID: 27648690 BACKGROUND

• Kolackova M, Kudlova M, Kunes P, Lonsky V, Mandak J, Andrys C, Jankovicova K, Krejsek J. Early expression of FcgammaRI (CD64) on monocytes of cardiac surgical patients and higher density of monocyte anti-inflammatory scavenger CD163 receptor in "on-pump" patients. Mediators Inflamm. 2008;2008:235461. doi: 10.1155/2008/235461.

  PMID: 18320015 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome; Infections; Aortic Aneurysm, Thoracic; Aortic Diseases

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jan Vojacek, Prof. MD

  University Hospital Hradec Kralove

  STUDY CHAIR

Central Study Contacts

Jan Gofus, MD, PhD

CONTACT

+420 722 301 527; jan.gofus@gmail.com

Andrej Myjavec, MD

CONTACT

andrej.myjavec@fnhk.cz

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: September 8, 2023
• Study Start: April 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)