Monitoring of Septic Shock-induced Immunosuppression (IMMUNOSEPSIS 5)
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).
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：VENET FABIENNE, Pr
- 電話番号：+33 4 72 11 97 46
- メール：fabienne.venet@chu-lyon.fr
研究連絡先のバックアップ
- 名前：SAUNIER Clarisse
- 電話番号：+33 04 27 85 62 64
- メール：clarisse.saunier@chu-lyon.fr
研究場所
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Lyon、フランス、69004
- Service d'Anesthésie-Réanimation Groupement Hospitalier Nord Hôpital de la Croix Rousse
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コンタクト：
- DELIGNETTE Marie-Charlotte, Dr
- 電話番号：+33 4 26 10 90 70
- メール：marie-charlotte.delignette@chu-lyon.fr
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Lyon、フランス、69004
- Service de Médecine Intensive - Réanimation (MIR) Groupement Hospitalier Nord Hôpital de la Croix Rousse
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コンタクト：
- BITKER Laurent, Dr
- 電話番号：+33 4 26 10 92 69
- メール：laurent.bitker@chu-lyon.fr
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Lyon、フランス、69437
- Service civilo-militaire d'Anesthésie-Réanimation et Médecine Périopératoire - Groupement Hospitalier Centre
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コンタクト：
- LUKASZEWICZ Anne-Claire, Pr
- 電話番号：+33 4 72 11 96 86
- メール：anne-claire.lukaszewicz@chu-lyon.fr
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Lyon、フランス、69437
- Service de Médecine Intensive - Réanimation (MIR) - Groupement Hospitalier Centre
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コンタクト：
- COUR Martin, Pr
- 電話番号：+33 4 72 11 28 52
- メール：martin.cour@chu-lyon.fr
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Pierre-Bénite、フランス、69495
- Service d'Anesthésie-Réanimation-Médecine Intensive Groupement Hospitalier Sud Hôpital Lyon Sud - Bâtiment 3B
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コンタクト：
- DARGENT Auguste, Dr
- 電話番号：+33 4 78 86 14 76
- メール：auguste.dargent@chu-lyon.fr
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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).
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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)
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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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
時間枠：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
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Modification of immune parameters compared with normal values in particular proportion of immunoregulatory cells
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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
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 69HCL25_0663
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
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