Myeloid-Derived Supressor Cells in Cardiac Surgery Patients

NCT ID: NCT02902939

Last Updated: 2018-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2018-07-19

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.

Conditions

Insufficiency; Cardiac, Complicating Surgery; Systemic Inflammatory Response Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Uncomplicated cardiac surgery patients

Patients after scheduled cardiac surgery procedures

Group Type: NO_INTERVENTION

No interventions assigned to this group

Complicated cardiac surgery patients

MECC systems Cytokines modulation by CytoSorb and PMMA membranes

Group Type: ACTIVE_COMPARATOR

minimal extracorporeal circulation (MEC)

Intervention Type: DEVICE

We should use the modification of extracorporeal circulation to reduce the systemic inflammatory response due to excessive haemodilution, allogenic blood transfusion.

The cytokines modulations

Intervention Type: PROCEDURE

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)

Interventions

minimal extracorporeal circulation (MEC)

We should use the modification of extracorporeal circulation to reduce the systemic inflammatory response due to excessive haemodilution, allogenic blood transfusion.

Intervention Type: DEVICE

The cytokines modulations

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)

Intervention Type: PROCEDURE

Other Intervention Names

CytoSorb devices,

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Research Institute for Complex Problems of Cardiovascular Diseases, Russia

OTHER

Sponsor Role: lead

Responsible Party

Evgeny Grigoryev

professor, the deputy director for scientific and clinical affairs, senior research specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Georgy Plotnikov

Kemerovo, , Russia

Countries

Russia

Other Identifiers

20161101

Identifier Type: -

Identifier Source: org_study_id