Myeloid-Derived Supressor Cells in Cardiac Surgery Patients (MyDeCCS)

Research Institute for Complex Problems of Cardiovascular Diseases, Russia

Status: Completed

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

Treatments: Device: minimal extracorporeal circulation (MEC); Procedure: The cytokines modulations

Study type: Interventional

Funder types: Other

Identifiers

NCT02902939

20161101

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. the patients with ischemia heart disease and/or valvular heart disease,
2. signed inform consent,
3. CABG and/or valve replacement/plastic procedures.

Exclusion criteria

1. congenital heart disease.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Uncomplicated cardiac surgery patients

No Intervention group

Description:

Patients after scheduled cardiac surgery procedures

Complicated cardiac surgery patients

Active Comparator group

Description:

MECC systems Cytokines modulation by CytoSorb and PMMA membranes

Treatment:

Device: minimal extracorporeal circulation (MEC)

Procedure: The cytokines modulations