Phase II, Multi-center, Randomized Control Trial of Beta- Hydroxy-Methyl-Butyrate (HMB) in Improving Physical Muscle Function, in Nutritionally at Risk, Elderly Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- 6 minute walk distance
研究概览
简要总结
The investigators propose to conduct a randomized, control trial of β-hydroxy-β-methylbutyrate (HMB) supplementation in elderly patients (≥65 years of age) with acute respiratory failure, who are identified at high risk for malnutrition by ICU-specific nutritional risk scores. Patients will receive either 3g of HMB daily, or control, daily until day 28 following randomization (even if discharged).The investigators will measure functional outcomes using standard, validated measures prior and after discharge.
详细描述
The investigators propose to conduct a randomized, control trial of HMB supplementation in elderly patients (≥65 years of age) with acute respiratory failure, who are identified at high risk for malnutrition by ICU-specific nutritional risk scores. Patients will receive either 3g of HMB daily, or control, daily until day 28 following randomization (even if discharged).the investigators will measure functional outcomes using standard, validated measures prior and after discharge.
The investigators hypothesize that this inexpensive nutrient, HMB, along with our supportive measures, reduces muscle loss, improves physical muscle function, and improves quality of life in the longer term following critical illness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age ≥65 years.
- •Acute respiratory failure (ARF, defined by expected mechanical ventilation for > 72 hours from the point of screening)
- •Elevated nutritional risk (NUTRIC score>5 - see below).
排除标准
- •Over 72 hours from ICU admission.
- •Not expected to survive another 48 hours
- •Lack of commitment to full, aggressive care
- •Patients who have an absolute contraindication to EN (obstruction, perforation, high output fistula),
- •Pregnant women
- •Known allergy to study nutrients
- •Unable to walk prior to current illness.
研究组 & 干预措施
HMB Protein Supplementation Group
Intervention patients will receive 2 x 237mL bottles of the commercially available liquid HMB protein supplement (3g) (Ensure Active™ Muscle Health) throughout the study.
In addition, all patients will be fed according to the Canadian Critical Nutrition Practice Guidelines, and protein/energy requirements will be determined by the local dietitians according to their local practice standards.
干预措施: HMB protein supplement (3g) (Dietary Supplement)
Control Group
Control patients will receive 2 x 237mL bottles of the commercially available nutritional supplement (Ensure® Original) throughout the study.
In addition, all patients will be fed according to the Canadian Critical Nutrition Practice Guidelines, and protein/energy requirements will be determined by the local dietitians according to their local practice standards.
干预措施: Nutritional Supplement (Dietary Supplement)
结局指标
主要结局
6 minute walk distance
时间窗: At 42 days follow up
Maximum distance walked by subject in 6 minutes on level ground
次要结局
- Body Composition-Quadriceps layer muscle thickness (QLMT)(At 42 days follow up)
- Body Composition-Calf circumference(At 42 days follow up)
- Timed Get Up and Go test(At 42 days follow up)
- Hand-grip strength (HGS)(At 42 days follow up)