Immuno Nutrition by L-citrulline for Critically Ill Patients (Immunocitre)
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
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Angers、法国
- Chu Angers
-
Nantes、法国
- CHU Nantes
-
Paris、法国
- Paris - HEGP
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Rennes、法国、35033
- Rennes Hospital University
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：L-Citrulline group
Enteral nutrition 5-day L-citrulline treatment (10 grams/day)
|
|
|
安慰剂比较：Control group
Enteral nutrition 5-day placebo treatment
|
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 |
|---|---|---|
|
Organ failure score comparison D7
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Organ failure score comparison D3
大体时间：At day 3
|
Organ failure score (SOFA score) on day 3 in the L-citrulline group as compared to the placebo group
|
At day 3
|
|
SOFA score evolution between randomisation and D7
大体时间：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
大体时间：At day 7
|
Expression of HLA-DR in the L-citrulline group as compared to the placebo group
|
At day 7
|
|
Plasmatic concentration of IL6
大体时间：At day 7
|
Comparison of the plasmatic concentration of interleukin-6 between the L-citrulline group and the placebo group
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At day 7
|
|
HLA-DR
大体时间：At day 7
|
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
|
|
Plasmatic concentration of L-arginine
大体时间：At day 7
|
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
|
|
Incidence of nosocomial infections
大体时间：during the stay in the ICU, an average of 7 days
|
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
|
|
Length of stay
大体时间：during the stay in hospital, up to 28 days
|
Length of stay in ICU and hospital: Comparison between the L-citrulline group and the placebo group
|
during the stay in hospital, up to 28 days
|
|
Mortality
大体时间：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
大体时间：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
|
during the stay in ICU, an average of 7 days
|
合作者和调查者
调查人员
- 首席研究员：Jean-Marc TADIE, MD、CHU Rennes
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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