Myeloid-Derived Supressor Cells in Cardiac Surgery Patients

Study Overview
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Brief Summary
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Pro- and anti-inflammatory response during the formation of the critical state develops at the same time. Because of its balanced or unbalanced systemic inflammation can be either aborted or able to lead to multiple organ failure. With regard to sepsis, systemic inflammatory response characteristics are well understood, is not achieved in respect of the sterile inflammation. Extracorporeal circulation is a clinical model of systemic inflammatory response due to non-physiological activation of tissue factor in the extracorporeal perfusion, the use of non-pulsatile circulation mode, intentional / unintentional hypothermia, bacterial translocation from the gastrointestinal tract and perfusion deficit. We have proved that the monocytes demonstrate suppressor function, which can be a predictor of complications from cardiac surgery patients. The most important component of the formation of multiple organ failure (MOF) in critically ill patients is immunosuppression. During the study of experimental and clinical tumor growth process scientists has provided a new population of immature myeloid cells (myeloid suppressor cells or suppressor cells of myeloid origin, MDSC). Most of the works have been devoted to the role of MDSC in the development of tumors, where it has been clearly shown that this cell population has an undoubted effect of immune suppression. However, recent studies show that the role of MDSC is not limited to cancer process, but extends to chronic or acute inflammation. The aim of this study is to determine the role of MDSC in the development of immune suppression and complications after heart surgery carried out under cardiopulmonary bypass.

Detailed Description
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The use of MEC systems can be useful to prevent the MDSC activation after cardiac surgery. The procedures to modulate the cytokines concentration can be useful to prevent the MDSC activation after cardiac surgery.

Official Title
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Myeloid-Derived Supressor Cells in Uncomplicated vs Complicated Patients After Cardiac Surgery

Conditions
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Insufficiency; Cardiac, Complicating Surgery, Systemic Inflammatory Response Syndrome

Intervention / Treatment
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* Device: minimal extracorporeal circulation (MEC)
* Procedure: The cytokines modulations


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: the patients with ischemia heart disease and/or valvular heart disease, signed inform consent, CABG and/or valve replacement/plastic procedures. Exclusion Criteria: 1) congenital heart disease.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Uncomplicated cardiac surgery patients<br>Patients after scheduled cardiac surgery procedures | |
| Active Comparator: Complicated cardiac surgery patients<br>MECC systems Cytokines modulation by CytoSorb and PMMA membranes | Device: minimal extracorporeal circulation (MEC)<br>* We should use the modification of extracorporeal circulation to reduce the systemic inflammatory response due to excessive haemodilution, allogenic blood transfusion.<br>Procedure: The cytokines modulations<br>* We should use the modification of cytokines by CytoSorb devices and cytokines removal by PMMA membranes during extracorporeal circulation in patients with risk factors of complications (long duration of extracorporeal circulation, re-do procedures and other)<br>* Other names: CytoSorb devices,;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MOF-free days |  | 28 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU length of stay |  | 28 day | 
| the incidents of infection complications |  | 28 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immune Suppression, Inflammatory Response, Cardiac Surgery