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

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

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.

Study Overview

• Status: Completed
• Conditions: Systemic Inflammatory Response Syndrome; Insufficiency; Cardiac, Complicating Surgery
• Intervention / Treatment: Device: minimal extracorporeal circulation (MEC); Procedure: The cytokines modulations

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Kemerovo, Russian Federation, 650002
    • Georgy Plotnikov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Uncomplicated cardiac surgery patients; Patients after scheduled cardiac surgery procedures
Active Comparator: Complicated cardiac surgery patients; MECC systems Cytokines modulation by CytoSorb and PMMA membranes	Device: 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.; Procedure: 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); Other Names: CytoSorb devices,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
MOF-free days	28 day

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): July 19, 2018
• Study Completion (Actual): July 19, 2018

Study Registration Dates

• First Submitted: September 4, 2016
• First Submitted That Met QC Criteria: September 15, 2016
• First Posted (Estimate): September 16, 2016

Study Record Updates

• Last Update Posted (Actual): July 20, 2018
• Last Update Submitted That Met QC Criteria: July 18, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Immune Suppression, Inflammatory Response, Cardiac Surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Inflammation; Shock; Heart Failure; Systemic Inflammatory Response Syndrome
• Other Study ID Numbers: 20161101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No