Effect of Whey Protein-enriched Enteral Nutrition in Addition to Standardized Exercise Training on the PREServation of MUScle Function in Critically Ill Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- in vitro loss of skeletal muscle function
研究概览
简要总结
This study evaluates the effect of whey protein enriched enteral nutrition in addition to exercise training on the preservation of muscle function in critically ill patients.
One half of patients receive whey protein enriched enteral nutrition with a protein intake of 1.5 g/kg/day and the other half of patients receive standard enteral nutrition with a protein intake of 1 g/kg/day.
详细描述
Muscle wasting has an enormous impact on long-term physical performance and quality of life of intensive care survivors. Limitation of muscle wasting might therefore improve physical performance and quality of life. Data on high protein nutritional intake in addition to a standardized exercise training program to prevent skeletal muscle wasting during critical illness are lacking.
Objective
to determine whether early high protein intake, using an enteral whey protein supplement, in addition to a standardized exercise training program and standard enteral nutrition preserves: a) in vitro skeletal muscle function in critically ill patients during the first week of intensive care unit (ICU) admission and b) short- and long-term in vivo muscle function and mass, clinical outcomes and quality of life in critically ill patients. Secondly, to determine whether high protein intake, in addition to standardized exercise and standard enteral nutrition, increases muscle protein synthesis and attenuates activation of the Ubiquitin-Proteasome pathway in critically ill patients.
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 (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
- •Admitted to the intensive care
- •Mechanically ventilated
- •Expected duration of ventilation of 72 hours
- •Expected to tolerate and require enteral nutrition for more than 72 hours
- •Sequential organ failure assessment (SOFA)-score>6 on admission day
- •Written informed consent of patient or legal representative
排除标准
- •Contra-indication to enteral nutrition
- •Short bowel syndrome
- •Child C liver cirrhosis or acute liver failure
- •Dialysis dependency
- •Requiring other specific enteral nutrition for medical reason
- •Body mass index (BMI) > 35 kg/m2
- •Extensive treatment limitations
- •Disseminated malignancy
- •Haematological malignancy
- •Primary neuromuscular pathology
- •Chronic use of corticosteroids for > 7 days before ICU admission
- •Contra-indication for muscle biopsy (need for uninterrupted systemic anticoagulation, prothrombin time >1.4 , Thrombocytes <100).
研究组 & 干预措施
intervention group
whey protein supplement enriched enteral nutrition, with protein intake of 1.5g/kg/day; in addition to standardized exercise training
干预措施: Whey protein supplement (Dietary Supplement)
control group
standard enteral nutrition, with protein intake of 1g/kg/day; in addition to standardized exercise training
结局指标
主要结局
in vitro loss of skeletal muscle function
时间窗: day 1-3 and day 8-10
measured by contractility of of individual muscle fibers
次要结局
- quality of life(3 months)
- loss of muscle function(day 1-3, day 8-10, day 28)
- changes in body composition(day 1-3, day 8-10, day 28)
- loss of muscle mass(day 1-3, day 8-10, day 28)
研究者
Sandra Stapel
intensivist
Amsterdam UMC, location VUmc