Can Beta-Hydroxy-beta-Methylbutyrate (HMB) Supplementation Counteract Muscle Catabolism in Critically Ill Patients? A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Muscle mass of the thigh
研究概览
简要总结
The rapid decline of muscle mass and function in mechanically ventilated critically ill patients is associated with prolonged length of mechanical ventilation, prolonged intensive care (ICU) and hospital stay, increased ICU and hospital mortality, and prolonged impairment in physical function and quality of life. High protein feeding only partially attenuates the muscle loss. The aim is to study the impact of HMB (3 g/day) on the muscle mass of the critically ill patients from day 4 of their admission to maximum 30 days, but at least for 10 days.
详细描述
The rapid decline of muscle mass and function in mechanically ventilated critically ill patients is associated with poor outcome, and limitations of functional recovery. High protein feeding only partially attenuates the muscle loss. The aim is to study the impact of HMB (3 g/day) on the muscle mass of the critically ill patients from day 4 of their admission to maximum 30 days, but at least for 10 days. The study is testing a nutrition complement (HMB) that is included in feeding products registered for medical nutrition by Swiss Federal Authorities, but who do not provide sufficient protein quantities.
On days 4 and 15 after ICU admission, specific investigations will include: Ultrasound measurement of the muscle quadriceps femoris (CSA), bioimpedance analysis (BIA) of body composition, protein synthesis and catabolism using amino acid tracers. On D30 and D60: telephone contact to assess global health and mobility (SF-12).
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)
盲法说明
Randomisation controlled by the Hospital Pharmacy Intervention product masked by the Hospital Pharmacy
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
- •likely length of stay >5 days
- •on mechanical ventilation
- •likely survival >7 days
- •full treatment
- •functional gastro-intestinal tract
- •presence of a central venous catheter
排除标准
- •absence of consent
- •less than 18 years patients
- •gastro-intestinal dysfunction
- •major burns >20% body surface
- •admission for cardio-respiratory arrest or brain injury
- •pregnancy or lactation
- •diabetes mellitus (I and II)
- •statin treatment
- •patient on parenteral nutrition
- •absence of central venous line
- •participation in another interventional trial
结局指标
主要结局
Muscle mass of the thigh
时间窗: Change between Day 4 and Day 15
Ultrasound cross sectional area of the thigh, to quantify muscle loss
次要结局
- Body composition(Change between Day 4 and Day 15)
- Protein synthesis and breakdown(Change between Day 4 and Day 15)
- Global Health and Mobility(on days 30 and 60)
- Muscle strength (global and handgrip)(Measurements on Days 4, 15, and 30)
研究者
Mette M Berger
Professor
Centre Hospitalier Universitaire Vaudois