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Completed

NCT Number: NCT02902939

Myeloid-Derived Supressor Cells in Cardiac Surgery Patients

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Georgy Plotnikov

Kemerovo, 650002, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • congenital heart disease.

Treatment and study plan

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.

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)

Other names: CytoSorb devices,

Primary outcomes

  1. MOF-free days

    Time frame: 28 day

Secondary outcomes

  1. ICU length of stay

    Time frame: 28 day

  2. the incidents of infection complications

    Time frame: 28 day

Sponsors and collaborators

Lead sponsor

Research Institute for Complex Problems of Cardiovascular Diseases, Russia

Other

Registry information

Official study title

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

Acronym: MyDeCCS

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 16, 2016
Registry last updated
Jul 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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