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临床试验/NCT06513520
NCT06513520已完成不适用

Evaluation of Monocyte Expression of HLA-DR (mHLA-DR) in the Multi-pathological Elderly Subject in Geriatric Service

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2025年1月6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
入组人数
81
试验地点
2
主要终点
mHLA DR expression

研究概览

简要总结

The acceleration of population aging and the improved management of comorbidities lead to an increase in the number of multi-pathological elderly patients admitted to geriatric services. This is an extremely specific population in terms of immunology due to the presence of immunosenescence (physiological aging of the immune system) and the potential additional effect of multiple chronic pathologies (comorbidities) presented by these patients.

The specific effect of multiple chronic pathologies on the immune status of elderly patients is currently underexplored because most studies on immune system aging only include elderly patients who do not have comorbidities or treatments that could impact the immune system (e.g. SENIEUR protocol). Therefore, their results are not applicable to patients in geriatric services.

The decrease in monocyte expression of HLA-DR (mHLA-DR) has been studied as a marker of immune alteration in intensive care units in the context of sepsis, but also in chronic pathologies (e.g. cancer, diabetes, renal insufficiency). These chronic pathologies are frequently found in elderly subjects.

The objective of the study would therefore be to investigate the relative contribution of age (immunosenescence) and comorbidities to the alteration of the immune status of geriatric patients through the measurement of mHLA-DR.

To date, no study has explored mHLA-DR in a population of multi-pathological geriatric patients. Our work aims to generate initial data through a pilot study in hospitalized multi-pathological subjects over 75 years old in geriatric services.

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
75 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • For all patients:
  • Patients aged over 75 hospitalised in one of the geriatric units defined as the research sites;
  • Patient affiliated to a social security scheme;
  • Patients or relatives who have been informed and have no objections to the research.
  • To be eligible in the acute situation sub-population:
  • - Patients presenting with an acute episode on admission or following a stay in the research sites; The acute episode is defined, for example, by an infection, cardiac decompensation, a complicated fall, acute renal failure, any acute or decompensated cardiovascular pathology, any discovery of cancer that has not been stabilised.
  • To be eligible in the stable situation sub-population:
  • - A patient who has not had an acute episode for at least 7 days.

排除标准

  • For all patients:
  • Patients under legal protection: curatorship, guardianship, safeguard of justice ;
  • Patients under exclusive comfort care for whom it has been decided not to take a blood sample;
  • Patients undergoing long-term antibiotic treatment, i.e. with no defined stopping date;
  • An immunocompromised patient or a patient undergoing immunosuppressive treatment (for example: HIV infection, a patient awaiting solid organ transplantation, a patient undergoing haematopoietic stem cell transplantation, a patient undergoing chemotherapy for a solid tumour or haematological malignancy, a patient suffering from an auto-immune disease and being treated with immunotherapy and/or immunosuppressive therapy and/or biotherapy, an asplenic or hyposplenic patient, a patient undergoing experimental potentially immunosuppressive treatment, a patient undergoing Eculizumab treatment, a patient presenting a hereditary immune deficiency).
  • For patients in an acute clinical situation:
  • - Patient previously included in the same sub-population.

研究组 & 干预措施

Patients in acute medical situation

Patients over 75 with polypathology hospitalised in geriatric wards, in acute situation: for example, patients presenting with an infection, cardiac decompensation, a complicated fall, acute renal failure, any acute or decompensated cardiovascular pathology, any discovery of cancer that has not been stabilised.

干预措施: Blood sampling (Biological)

Patients in stable medical situation

Patients over 75 with polypathology hospitalised in geriatric wards, in a stable situation: these are patients who have not had an episode of decompensation or infection for at least 7 days.

干预措施: Blood sampling (Biological)

结局指标

主要结局

mHLA DR expression

时间窗: up to 72 Hour

Expression of mHLA DR assessed by flow cytometry and expressed as the number of antibodies bound per monocyte.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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