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临床试验/NCT05040503
NCT05040503已完成不适用

Monitoring Mitophagy In Myeloid Cells Upon Intensive Care

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 205 人开始时间: 2021年8月25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
205
试验地点
1
主要终点
Level of mitophagy

研究概览

简要总结

Severe infections (sepsis) are a frequent cause of admission to the intensive care unit. Sepsis represent a significant risk for the health of patients in the short and medium term. Sepsis are notably linked to a change in the function of immune cells. In some patients, a state of pseudo-dormancy of monocyte and macrophage immune cells, called myeloid cell immunosuppression, is observed. This situation, which leads to a worsening of the infection, must be avoided because it represents a danger for the patient, even during antibiotic therapy. At present, these events are still very poorly understood. Research is needed to understand how the immunosuppression of myeloid cells occurs in order to adapt existing treatments or to find new ones.

Laboratory work on animal models of sepsis has shown that this state of myeloid cell immunosuppression is closely linked to a modification of energy production by myeloid cells (monocytes and macrophages). The function of the mitochondria ("energy factory" of the cells) in these cells is impaired. Thus, restoring mitochondrial function in myeloid cells could be a therapeutic solution against the immunosuppression of myeloid cells during severe sepsis.

The aim of this study is to verify whether alterations in mitochondrial function in myeloid cells occur in both patients with and without bacterial infection.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

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

  • Criteria common to all 4 groups:
  • Patient (and/or trusted person/health care proxy or relative) or volunteer who provided oral consent after receiving information about the study, or patient included in emergency situation
  • Age ≥ 18 years
  • Common criteria for patients
  • Admission to the Intensive Care Unit or the Anesthesia and Intensive Care Unit of the Dijon University Hospital

排除标准

  • Person not affiliated to national health insurance
  • Person subject to a measure of legal protection (curatorship, guardianship)
  • Person subject to limited judicial protection
  • Pregnancy or breastfeeding
  • Known primary or secondary immune deficiency (radiotherapy, chemotherapy, immunosuppressive treatment or systemic corticosteroid therapy in the 3 months preceding inclusion (> 0.15 mg/kg/d of prednisone equivalent for more than 2 weeks or "bolus" greater than 2mg/kg/d of prednisone equivalent), HIV infection, primary cellular immune deficiency)
  • Patients hospitalized within 3 months prior to inclusion for sepsis.
  • Patients receiving therapy known to modulate mitochondrial function, mitochondrial biogenesis or mitophagy (chloroquine, hydroxychloroquine, rapamycin, carbamazepine, resveratrol, sildenafil)
  • Patients with COVID-19

研究组 & 干预措施

Patients without sepsis

Active Comparator

patient without sepsis admitted to the Intensive Care Unit or the Anesthesia and Intensive Care Unit of the Dijon University Hospital

干预措施: Blood sampling at inclusion (Biological)

Patients without sepsis

Active Comparator

patient without sepsis admitted to the Intensive Care Unit or the Anesthesia and Intensive Care Unit of the Dijon University Hospital

干预措施: Blood sampling at 24 hours (Biological)

Patients without sepsis

Active Comparator

patient without sepsis admitted to the Intensive Care Unit or the Anesthesia and Intensive Care Unit of the Dijon University Hospital

干预措施: Data collection (Other)

Patients with sepsis

Experimental

Patients with sepsis admitted to the Intensive Care Unit or the Anesthesia and Intensive Care Unit of the Dijon University Hospital

干预措施: Blood sampling at inclusion (Biological)

Patients with sepsis

Experimental

Patients with sepsis admitted to the Intensive Care Unit or the Anesthesia and Intensive Care Unit of the Dijon University Hospital

干预措施: Blood sampling at 24 hours (Biological)

Patients with sepsis

Experimental

Patients with sepsis admitted to the Intensive Care Unit or the Anesthesia and Intensive Care Unit of the Dijon University Hospital

干预措施: Data collection (Other)

Patients with septic shock

Experimental

Patients with septic shock admitted to the Intensive Care Unit or the Anesthesia and Intensive Care Unit of the Dijon University Hospital

干预措施: Blood sampling at inclusion (Biological)

Patients with septic shock

Experimental

Patients with septic shock admitted to the Intensive Care Unit or the Anesthesia and Intensive Care Unit of the Dijon University Hospital

干预措施: Blood sampling at 24 hours (Biological)

Patients with septic shock

Experimental

Patients with septic shock admitted to the Intensive Care Unit or the Anesthesia and Intensive Care Unit of the Dijon University Hospital

干预措施: Data collection (Other)

Healthy volunteers

Active Comparator

干预措施: Blood sampling at inclusion (Biological)

Healthy volunteers

Active Comparator

干预措施: Data collection (Other)

结局指标

主要结局

Level of mitophagy

时间窗: at admission and at 24 hours post-admission

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 (1)

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