Myeloid-Derived Supressor Cells in Cardiac Surgery Patients

Not Applicable

Completed

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

• Registration Number: NCT02902939
• Lead Sponsor: Research Institute for Complex Problems of Cardiovascular Diseases, Russia

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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-04
• Study First Submitted QC: 2016-09-15
• Study First Posted: 2016-09-16
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-18
• Primary Completion: 2018-07-19
• Study Completion: 2018-07-19
• Last Update Posted: 2018-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Complicated cardiac surgery patients	minimal extracorporeal circulation (MEC)	MECC systems Cytokines modulation by CytoSorb and PMMA membranes
Complicated cardiac surgery patients	The cytokines modulations	MECC systems Cytokines modulation by CytoSorb and PMMA membranes

Primary Outcome Measures

Name	Time	Method
MOF-free days	28 day

Secondary Outcome Measures

Name	Time	Method
the incidents of infection complications	28 day
ICU length of stay	28 day

Trial Locations

Locations (1)

Georgy Plotnikov; 🇷🇺 Kemerovo, Russian Federation