Myeloid-Derived Supressor Cells in Cardiac Surgery Patients

NCT02902939 | Completed

• 1 other identifier: 20161101
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Insufficiency; Cardiac, Complicating Surgery; Systemic Inflammatory Response Syndrome

Keywords

Immune Suppression, Inflammatory Response, Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• MOF-free days

  28 day

Secondary Outcomes (2)

• ICU length of stay

  28 day

• the incidents of infection complications

  28 day

Study Arms (2)

Uncomplicated cardiac surgery patients

NO INTERVENTION

Patients after scheduled cardiac surgery procedures

Complicated cardiac surgery patients

ACTIVE COMPARATOR

MECC systems Cytokines modulation by CytoSorb and PMMA membranes

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

Interventions

minimal extracorporeal circulation (MEC) DEVICE

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

Complicated cardiac surgery patients

The cytokines modulations 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)

Also known as: CytoSorb devices,

Complicated cardiac surgery patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \) congenital heart disease.

Sponsors & Collaborators

• Research Institute for Complex Problems of Cardiovascular Diseases, Russia: lead

Study Sites (1)

Georgy Plotnikov

Kemerovo, 650002, Russia

Location

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor, the deputy director for scientific and clinical affairs, senior research specialist

Study Record Dates

• First Submitted: September 4, 2016
• First Posted: September 16, 2016
• Study Start: September 1, 2016
• Primary Completion: July 19, 2018
• Study Completion: July 19, 2018
• Last Updated: July 20, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)