Clinical trial NCT02902939: Myeloid-Derived Supressor Cells in Cardiac Surgery Patients
Official title: Myeloid-Derived Supressor Cells in Uncomplicated vs Complicated Patients After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insufficiency; Cardiac, Complicating Surgery
Systemic Inflammatory Response Syndrome
Keywords: Immune Suppression, Inflammatory Response, Cardiac Surgery
Lead sponsor: Research Institute for Complex Problems of Cardiovascular Diseases, Russia
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: MOF-free days
timeFrame: 28 day
Secondary outcomes:
measure: ICU length of stay
timeFrame: 28 day
measure: the incidents of infection complications
timeFrame: 28 day
Other outcomes:
Locations:
city: Kemerovo
country: Russian Federation
facility: Georgy Plotnikov
Study officials:
References: