Descriptive Study of the Evolution in Proportion of Regulatory B Lymphocytes in Patients Hospitalized in Intensive Care for Severe Sepsis (DELyBREG)
Severe sepsis and septic shock are the most severe forms of sepsis (which associates a systemic inflammatory response with infection). These are serious pathologies with a lethality estimated at almost 40% at 28 days (after the onset of sepsis).
After a first pro-inflammatory phase, a second compensatory phase called Compensatory Anti-Inflammatory Response Syndrome (CARS) takes place quickly. Patients then show signs of immunosuppression and profound alterations in immune functions. It is during this phase that the vast majority of deaths occur, far from the onset of the shock, which is related to the inability of the immune system to eliminate the initial infectious agent and / or a greater susceptibility Important to develop secondary infections (nosocomial infection, latent virus reactivation ...).
The CARS phase has been the subject of studies focusing on measuring the plasma concentration of anti-inflammatory cytokines (such as Interleukin (IL) -10), the percentage of regulatory T lymphocytes (Treg), Or the percentage of monocytic expression of HLA-DR in septic patients.
The investigator proposes to carry out the first study on a newly described regulatory lymphocytic subpopulation: regulatory B lymphocytes (Breg) from a quantitative and functional point of view in severe septic states.
調査の概要
状態
条件
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Picardie
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Amiens、Picardie、フランス、80054
- 募集
- CHU Amiens Picardie
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Adult patients with severe sepsis or septic shock diagnosed less than 24 hours (defined as D0) and hospitalized in the medical resuscitation department of the Amiens-Picardie University Hospital.
The definitions of severe sepsis and septic shock are the result of the consensus of the Société de Réanimation de Langue Française dating from 2005:
- Sepsis refers to a systemic inflammatory response syndrome (SIRS) in the presence of suspected or identified infection. Sepsis is said to be severe when lactate> 4 mmol / L or arterial hypotension prior to filling or organ dysfunction is present (one is sufficient): hypoxemia with a PaO2 / FIO2 <300 ratio, renal failure with Hepatic insufficiency with INR> 4 or bilirubin> 78 μmol / l, thrombocytopenia (platelets <100 000 / mm3) and hepatic insufficiency> 176 μmol / l, coagulation disorders with INR> 1.5 Disorders of higher functions with a Glasgow Coma Score <13.
- Finally, septic shock is defined as a severe sepsis condition with persistent hypotension despite a well-conducted vascular filling (20-40 ml / kg isotonic saline).
Exclusion Criteria:
- Patient with active neoplasia, immune deficiency, autoimmune disease or autoimmune disease.
- Patient under tutorship or curatorship
- Taking an immunomodulatory or immunosuppressive treatment at the time of the study or the year prior to hospitalization for sepsis.
- Antecedent or haematopoietic graft in progress.
- Pregnancy in progress.
- Known history of infection with human immunodeficiency virus (HIV) type 1 or 2 or with hepatitis B or C virus
- Patient with agranulocytosis (defined as neutrophils <0.5 G / L).
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
- 主な目的:他の
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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他の:Adult patients with severe sepsis
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Describe for the first time the kinetics of evolution in proportion of the circulating Brég in patients with severe septic state, at times D0, D2, D7 and D14 (or on leaving the service if before D14) of hospitalization in medical reanimation.
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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 |
時間枠 |
|---|---|
|
Variation in the proportion of circulating Breg compared to total B lymphocytes in the included cohort of patients
時間枠:28 days
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28 days
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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
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