Immuno Nutrition by L-citrulline for Critically Ill Patients (Immunocitre)
調査の概要
詳細な説明
This is a multicentric therapeutic trial, randomized and double blind: standard enteral nutrition plus L-citrulline (5 grams/12 Hours for 5 days from the admission in Intensive Care Unit (ICU)) versus standard enteral nutrition plus placebo.
Methods-Patients: Non-surgical patients admitted in medical intensive care unit, under mechanical ventilation for an expected duration > 2 days, without severe sepsis or septic shock, will be enrolled. Symptoms leading for ICU admission ongoing for five days maximum. On admission (before treatment), the severity will be evaluated with the Sepsis-related Organ Failure Assessment (SOFA) score together with an assessment of plasmatic arginine, cytokines (InterLeukin-6 (IL6) ), and expression of Human Leukocyte Antigen - antigen D Related (HLA-DR) by monocytes. The same evaluation will be repeated on day 3 (during treatment) and on day 7 (after treatment).
The enrolment of 100 patients is statistically enough to demonstrate a decreased SOFA scores in the L-citrulline group as compared to the placebo group on day 7.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Angers、フランス
- CHU Angers
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Nantes、フランス
- CHU Nantes
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Paris、フランス
- Paris - HEGP
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Rennes、フランス、35033
- Rennes Hospital University
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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:
- age > 18 years
- medical patient (absence of recent surgery or trauma)
- initial aggression < 5 days
- mechanically ventilated with expected duration of mechanical ventilation > 2 days
- exclusive enteral nutrition
- absence of previous immunosuppression
Exclusion Criteria:
- severe sepsis
- septic shock
- obesity defined as BMI above 40
- pregnancy
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：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：L-Citrulline group
Enteral nutrition 5-day L-citrulline treatment (10 grams/day)
|
|
|
プラセボコンパレーター：Control group
Enteral nutrition 5-day placebo treatment
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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 |
|---|---|---|
|
Organ failure score comparison D7
時間枠：At day 7
|
Organ failure score (SOFA score) on day 7 in the L-citrulline group as compared to the placebo group
|
At day 7
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Organ failure score comparison D3
時間枠：At day 3
|
Organ failure score (SOFA score) on day 3 in the L-citrulline group as compared to the placebo group
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At day 3
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SOFA score evolution between randomisation and D7
時間枠：up to 7 days
|
Binary criterion of success or failure : - Success is defined by: an improved SOFA score of at least 2 points from randomization to Day 7 or an improvement in the general condition yielding the release of the unit; - Failure is defined by an improved SOFA score but less than 2 points, no improvement or worsening of the SOFA score from randomization to Day 7 or the patient's death before J7; |
up to 7 days
|
|
Expression of HLA-DR
時間枠：At day 7
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Expression of HLA-DR in the L-citrulline group as compared to the placebo group
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At day 7
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Plasmatic concentration of IL6
時間枠：At day 7
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Comparison of the plasmatic concentration of interleukin-6 between the L-citrulline group and the placebo group
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At day 7
|
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HLA-DR
時間枠：At day 7
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Comparison of the percentage of expression of monocytic HLA-DR between the L-citrulline group and the placebo group
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At day 7
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Plasmatic concentration of L-arginine
時間枠：At day 7
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Comparison of the plasmatic concentration of L-arginine and its metabolites between the L-citrulline group and the placebo group
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At day 7
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Incidence of nosocomial infections
時間枠：during the stay in the ICU, an average of 7 days
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Comparison between the L-citrulline group and the placebo group
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during the stay in the ICU, an average of 7 days
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Length of stay
時間枠：during the stay in hospital, up to 28 days
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Length of stay in ICU and hospital: Comparison between the L-citrulline group and the placebo group
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during the stay in hospital, up to 28 days
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Mortality
時間枠：during the stay in hospital, up to 28 days
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during the stay in hospital, up to 28 days
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Duration of mechanical ventilation
時間枠：during the stay in ICU, an average of 7 days
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Duration of mechanical ventilation: Comparison between the L-citrulline group and the placebo group
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during the stay in ICU, an average of 7 days
|
協力者と研究者
捜査官
- 主任研究者：Jean-Marc TADIE, MD、CHU Rennes
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
プラセボの臨床試験
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