Immuno Nutrition by L-citrulline for Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 5
- 主要终点
- Organ failure score comparison D7
研究概览
简要总结
The main objective of this study is to demonstrate that the only administration of L-citrulline, can improve immune functions in critically ill patients at high risk of nosocomial infection.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •severe sepsis
- •septic shock
- •obesity defined as BMI above 40
- •pregnancy
结局指标
主要结局
Organ failure score comparison D7
时间窗: At day 7
Organ failure score (SOFA score) on day 7 in the L-citrulline group as compared to the placebo group
次要结局
- Organ failure score comparison D3(At day 3)
- Plasmatic concentration of IL6(At day 7)
- Mortality(during the stay in hospital, up to 28 days)
- Plasmatic concentration of L-arginine(At day 7)
- Incidence of nosocomial infections(during the stay in the ICU, an average of 7 days)
- Duration of mechanical ventilation(during the stay in ICU, an average of 7 days)
- Expression of HLA-DR(At day 7)
- HLA-DR(At day 7)
- Length of stay(during the stay in hospital, up to 28 days)
- SOFA score evolution between randomisation and D7(up to 7 days)