The Efficacy and Safety of High Nitrogen Intake in Critically Ill Patients: a Randomized and Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- all cause mortality
研究概览
简要总结
The patients with sepsis are in high risk of malnutrition, which could contribute to infection, difficulty in weaning from ventilators. The investigators speculate whether nutrition therapy with high nitrogen could attenuate the malnutrition status and improve the outcome in these sepsis patients. In this prospective Randomized Controlled Trial, the investigators aim to compare high nitrogen intake with conventional nitrogen supply which were recommended in guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •need mechanical ventilation for more than 2 days
- •mean blood pressure more than 60mmHg
- •predicted ICU stay more than 7 days
- •tolerance of parenteral or enteral nutrition
排除标准
- •irreversible status of primary disease
- •any history of malnutrition before enrollment
- •history of steroid cortisol administration
- •severe liver dysfunction (Child-Pugh Score C)
- •pregnancy
- •refuse to enrollment
- •re-admission to ICU and has been enrolled during former admission to ICU
研究组 & 干预措施
High Nitrogen
In this arm, daily nitrogen supply is as much as 2.5-3.0 g per kilogram (lean mass weight)
干预措施: nitrogen supply (Other)
conventional nitrogen
In this arm, daily nitrogen supply is 1.2-1.5g per kilogram (lean mass weight) as recommended by ESPEN guideline
干预措施: nitrogen supply (Other)
结局指标
主要结局
all cause mortality
时间窗: 90 days
all cause mortality
时间窗: 28 days
次要结局
- diameter of midpoint of musculus rectus femoris(on 28th. day or endpoint of the trial)
- serum concentration of albumin, pre albumin, retinaldehyde binding protein, transferrin(on 7th. day , 14th. day, 21st. day, 28th. day after enrollment)
- change of body composition(on 7th.day, 14th.day, 21st.dat, 28th.day after enrollment)
- duration on ventilators(patients enrolled will be followed for the duration of mechanical ventilation, an expcected average of 4 weeks)
- ICU stay(patients enrolled will be followed for length of ICU stay, an expected average of 6 weeks)
- infection incidence rate(28 days)
- Liver function and renal function(on 1st. day, 3rd. day, 7th. day, 14th. day, 21st. day, 28th. day after enrollment)
研究者
Ming Zhong
Associate Professor of Division of Critical Care Medicine
Shanghai Zhongshan Hospital