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Идёт набор NCT04067674

Septic Shock-induced Immunosuppression

— Наблюдательное Septic Shock

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Blood sampling.
Кому может быть актуально
Состояния в реестре: Septic Shock. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Evaluation of Immunosuppression in Septic Shock: Biomarkers and Pharmacological Restoration

Обзор

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. The prerequisite for immunostimulation administration (Interferon gama (IFNg), Granulocyte Macrophage Colony Stimulating Factor (GM-CSF), interleukin 7 (IL-7)) however relies on clinicians' capacity to identify patients who could benefit the most from these immunoadjuvant therapies, as there is no clinical sign of immune dysfunctions. In this context, the main objectives of IMMUNOSEPSIS 4 study are: 1. to identify the best biomarkers for sepsis-induced immunosuppression 2. to evaluate ex vivo candidate treatments which could rejuvenate immune functions after septic shock

Вмешательства

  • Биопрепарат Blood sampling
    Blood sampling for biomarker measurement

Первичные конечные точки

  • Major Histocompatibility Complex (MHC) class II expression rate [Срок оценки: at day 3 post septic shock diagnosis]
Вторичные конечные точки (2)
  • ICU-acquired infections occurence [Срок оценки: 28 days post septic shock diagnosis]
  • mortality rate [Срок оценки: 28 days post septic shock diagnosis]

Критерии участия

Критерии включения

  • Age over 18 years
  • Patient admitted to ICU
  • Diagnosis of septic shock within less than 48h at time of screening defined by :
  • Presence of a microbiologically diagnosed or suspected infection
  • Initiation of a vasopressive treatment to maintain mean arterial blood pressure ≥ 65 mm Hg initiated during the first 48h after ICU admission
  • Presence of an hyperlactatemia > 2 mmol/L (18 mg/dL) during the 24h before or after initiation of vasopressive treatment despite adequate volemic reanimation (30 ml/kg)
  • Blood sample at D3/D4 available (lab working days)
  • Non opposition to study participation obtained from patient or next of kin

Критерии исключения

  • Pregnant or breastfeeding woman
  • Patient with no social security insurance, with restricted liberty or under legal protection
  • Language barrier
  • Patient taking part in interventional study about medicin that could interfere with biologic results

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • Hôpital Edouard Herriot — Lyon

Публикации

  • Venet M, Bidar F, Derive M, Delwarde B, Monard C, Hengy B, Jolly L, Rimmele T, Lukaszewicz AC, Monneret G, Venet F. Persistently Elevated Soluble Triggering Receptor Expressed on Myeloid Cells 1 and Decreased Monocyte Human Leucocyte Antigen DR Expression Are Associated With Nosocomial Infections in Septic Shock Patients. Crit Care Explor. 2023 Feb 24;5(3):e0869. doi: 10.1097/CCE.0000000000000869. PMID 36861044
  • Coudereau R, Gossez M, Py BF, Henry T, Lukaszewicz AC, Monneret G, Venet F. Monitoring NLRP3 Inflammasome Activation and Exhaustion in Clinical Samples: A Refined Flow Cytometry Protocol for ASC Speck Formation Measurement Directly in Whole Blood after Ex Vivo Stimulation. Cells. 2022 Oct 20;11(20):3306. doi: 10.3390/cells11203306. PMID 36291172

Идентификаторы

NCT: NCT04067674 · 69HCL19_0071

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗