NCT02990065已完成不适用
Optimizing Protein Intake and Nitrogen Balance in Adult Critically Ill Patients: a Randomized Controlled Trial (OPINiB STUDY)
University of Padova0 个研究点目标入组 40 人开始时间: 2017年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- nitrogen balance (gr)
研究概览
简要总结
The purposes of the study are:
- To strictly ensure the appropriate level of protein and caloric provision in critical illness, according to the latest literature recommendation;
- To determine if an association exists between protein intake and nitrogen balance in the context of a nutrition with appropriate protein provision based on the latest literature recommendations, rather than in a standard diet with a caloric target weight-based. Creatinine clearance will also be evaluated to determine if there is any harmful effect to the kidney secondary to an elevated BUN.
- To determine if there is a difference in ICU mortality rate between the current nutrition standard and a hyperproteic nutrition protocol.
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
- Single (Participant)
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
- •Receiving PN and/or EN nutrition
- •Indwelling urinary catheter
- •Mechanically ventilated patients
排除标准
- •Age < 18 years
- •Chronic renal or hepatic failure
- •Current or history (past 6 months) of GI bleeding
- •BMI >30 kg/m2 o <18 kg/m2
- •Terminally ill patients
- •Pregnancy
结局指标
主要结局
nitrogen balance (gr)
时间窗: change from baseline through study completion, an average of 15 days
(gr)
次要结局
未报告次要终点
研究者
Dario Gregori
Associate Professor
University of Padova
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