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Monitoring of Septic Shock-induced Immunosuppression (IMMUNOSEPSIS 5)

2026年7月9日 更新者：Hospices Civils de Lyon

Immunological and Clinical Monitoring of Patients With Septic Shock in Intensive Care Unit : In-depth Immunophenotyping of Circulating Immunoregulatory Cells During Sepsis

Septic syndromes are a major although largely under-recognized health care problem and represent the first cause of mortality in intensive care units (ICU). While it has long been known that sepsis deeply perturbs immune homeostasis by inducing a tremendous systemic inflammatory response, novel findings indicate that sepsis indeed initiates a more complex immune response that varies over time, with the concomitant occurrence of both pro- and anti-inflammatory mechanisms. As a resultant, after a short pro-inflammatory phase, septic patients enter a stage of protracted immunosuppression. This is illustrated in those patients by reactivation of dormant viruses (cytomegalovirus (CMV) or Herpes Simplex Virus (HSV)) or infections due to pathogens, including fungi, which are normally pathogenic solely in immunocompromised hosts. These alterations might be directly responsible for worsening outcome in patients who survived initial resuscitation as nearly all immune functions are deeply compromised. New promising therapeutic strategies are currently emerging from those recent findings such as adjunctive immunostimulation for the most immunosuppressed patients.

Recent studies have described the induction of immunoregulatory cells (of myeloid and lymphoid origin) following septic shock and have revealed a similar induction kinetics across all subpopulations of regulatory cells. Nevertheless, these observations need to be confirmed and linked to the underlying mechanisms responsible for the induction of these cells (notably the activation of the inflammasome pathway), which remain largely unknown.

IMMUNOSEPSIS 5 study will therefore, as part of a prospective observational study involving a large cohort of patients, demonstrate the concurrent induction of all regulatory cell subpopulations following sepsis and the activation of the hyper-inflammatory response, including the inflammasome pathway. The association between these parameters and patient outcomes will also be assessed (death and/or the occurrence of a secondary infection).

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

观察性的

注册 (估计的)

300

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 法国
      • Lyon、法国、69004
        • Service d'Anesthésie-Réanimation Groupement Hospitalier Nord Hôpital de la Croix Rousse
        • 接触：
      • Lyon、法国、69004
        • Service de Médecine Intensive - Réanimation (MIR) Groupement Hospitalier Nord Hôpital de la Croix Rousse
        • 接触：
      • Lyon、法国、69437
        • Service civilo-militaire d'Anesthésie-Réanimation et Médecine Périopératoire - Groupement Hospitalier Centre
        • 接触：
      • Lyon、法国、69437
        • Service de Médecine Intensive - Réanimation (MIR) - Groupement Hospitalier Centre
        • 接触：
      • Pierre-Bénite、法国、69495
        • Service d'Anesthésie-Réanimation-Médecine Intensive Groupement Hospitalier Sud Hôpital Lyon Sud - Bâtiment 3B
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

This study will focus on adult patients admitted to the intensive care unit for the management of septic shock, defined according to the SEPSIS-3 criteria

描述

Inclusion Criteria:

  • Men or women aged 18 years or over
  • Hospitalised patients with septic shock that began less than 48 hours prior to screening, defined by:
  • the presence of a diagnosed or suspected site of infection requiring microbiological sampling
  • the need for vasopressor therapy to maintain a mean arterial pressure ≥ 65 mm Hg
  • hyperlactataemia > 2 mmol/L (18 mg/dL) within 24 hours of the start of vasopressor therapy despite adequate fluid resuscitation (30 ml/kg).
  • A patient or relative who has been informed of the study protocol and has not objected to participating in the study

Exclusion Criteria:

  • Pregnant or breastfeeding women
  • People not covered by a social security scheme or similar scheme
  • Adults subject to legal guardianship (guardianship, curatorship)
  • Patients with a language barrier
  • Persons deprived of their liberty by a judicial or administrative decision
  • Subjects participating in another interventional research study involving an exclusion period that is still ongoing at the time of pre-inclusion and which, in the investigator's judgement, may interfere with this study

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
Adult patient with septic shock
Additional tubes will be collected for the study at the same time as routine blood sample procedure. No specific intervention will be performed for this study. Theses samples will be collected at the following timing : inclusion, J3, J5, J15, J25 (until patient is discharged from intensive care).
生物：Additional tubes during routine blood sample collection
Four additional tubes will be collected during the blood sample carried out as part of standard of care : a 4 mL EDTA tube, a 2.5 mL heparin tube, a 5 mL CytoChex tube and a 4 mL PAXGENE tube.These samples will be taken at inclusion, J3, J5, J15, J25 (until patient is discharged from intensive care)

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Study of the mechanisms regulating the immune response during septic shock, and in particular study of regulatory cell subpopulations in a large cohort of adult patients with septic shock
大体时间：Inclusion DAY 1 (within the 48 hours of starting vasopressor therapy) Between DAY 3 and DAY 4 Between DAY 5 and DAY 7 Between DAY 15 and DAY 20 Between DAY 25 and DAY 30
Modification of immune parameters compared with normal values in particular proportion of immunoregulatory cells
Inclusion DAY 1 (within the 48 hours of starting vasopressor therapy) Between DAY 3 and DAY 4 Between DAY 5 and DAY 7 Between DAY 15 and DAY 20 Between DAY 25 and DAY 30

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Hospices Civils de Lyon

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2031年3月1日

研究完成 (估计的)

2031年12月1日

研究注册日期

首次提交

2026年7月2日

首先提交符合 QC 标准的

2026年7月9日

首次发布 (实际的)

2026年7月13日

研究记录更新

最后更新发布 (实际的)

2026年7月13日

上次提交的符合 QC 标准的更新

2026年7月9日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 69HCL25_0663

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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