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临床试验/NCT02902939
NCT02902939已完成不适用

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

Research Institute for Complex Problems of Cardiovascular Diseases, Russia2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
MOF-free days

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • congenital heart disease.

研究组 & 干预措施

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

干预措施: minimal extracorporeal circulation (MEC) (Device)

Complicated cardiac surgery patients

Active Comparator

MECC systems Cytokines modulation by CytoSorb and PMMA membranes

干预措施: The cytokines modulations (Procedure)

结局指标

主要结局

MOF-free days

时间窗: 28 day

次要结局

  • the incidents of infection complications(28 day)
  • ICU length of stay(28 day)

研究者

发起方
Research Institute for Complex Problems of Cardiovascular Diseases, Russia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Evgeny Grigoryev

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

Research Institute for Complex Problems of Cardiovascular Diseases, Russia

研究点 (2)

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