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临床试验/NCT03617796
NCT03617796Unknown不适用

Prognostic Value of CD64 Marker for Patients in Intensive Care Unit

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年9月10日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Mortality at 28 days after admission

研究概览

简要总结

Among patients admitted to the intensive care unit (ICU), early recognition of those with the highest risk of death is of paramount importance. Since clinical judgment is sometimes uncertain biomarkers could provide additional information likely to guide critical illness management. We want to evaluate the prognostic value of leucocyte surface expression of CD64.

Blood samples for CD64 biomarker measurement will be obtained daily during the patient's hospitalization. The primary outcome was all-cause death at D28 after admission

详细描述

Some local or systemic biological markers, using highly specialized techniques, have an interest that remains quite marginal in routine.

Markers of inflammation generally have elevated concentrations in circulating blood, but these increases are not specific for prognosis. This is the case of pro-inflammatory cytokines (TNF, IL-1, IL-6...)[1, 2] and especially, so-called'acute phase' proteins such as C-reactive protein (CRP) and procalcitonin. It is now well established that the rise in the CRP is totally non-specific. With regard to procalcitonin, the published data are far from univocal[3-4], in particular because of the heterogeneity of the populations studied (emergency services, medical services, intensive care).

These conventional biological assays are therefore not very informative and less efficient than the clinical-biological scores used in routine (SAPSII and SOFA).

An alternative diagnostic approach relies on molecular changes in the cellular compartment of innate immunity. Activation of neutrophil polymorphils (PNN) is the result of the pro/anti-inflammatory cytokinic balance and hormonal cascades In other words, the degree of activation of NNPs can be considered as the barometer of the intensity of any acute inflammatory phenomenon. One of the most specific indicators of a systemic inflammatory response is the increased expression of CD64, a high affinity receptor to the immunoglobulin fragment Fcγ, on the surface of PNNs.

CD64 expression elevation is induced in 4-6 hours by numerous cytokines (G-CSF, IFN- γ[5-7]. Given the very low basal expression level of CD64 (less than 2000 sites per cell) and its rate of elevation in case of inflammation, its determination could prove interesting in demonstrating the inflammatory response and its intensity.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Patients admitted to the intensive care unit

排除标准

  • Neutropenia (<500 neutrophils/mm3)
  • Treatment by G-CSF or IFN-γ during the week preceding admission to intensive care
  • Age < 18 years
  • Pregnancy
  • Patient refusal

结局指标

主要结局

Mortality at 28 days after admission

时间窗: 28 days

次要结局

未报告次要终点

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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