Time to Protein Target, the 'HIGH WHEY' Study A Prospective Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The proportion of patients reaching the individualized protein target (≥1.2 g/kg ideal body weight/day) 96 hours after ICU admission
研究概览
简要总结
This study evaluates the feasibility of a high whey-protein enteral nutrition formula in 20 ventilated ICU patients. The primary endpoint of study is the feasibility to attain the individualized protein target (≥1.2 g/kg ideal body weight/day) 96-hours after ICU admission. Secondary endpoints include tolerance and efficacy in terms of the amino acid response in blood.
详细描述
In the present pilot study, the investigators will use a high whey-protein nutrition formula during the first four days of ICU admission. The reason for using a high protein nutrition is that the investigators previously found that an early high protein intake in non-septic non-overfed patients was associated with lower hospital mortality (Weijs PJM et. al., Critical Care 2014,18). Furthermore, during the first days of critical illness tolerance to full enteral nutrition is often diminished. The use of a high protein nutrition will facilitate an early high protein intake.
The whey protein is hydrolysed. Hydrolyzation of protein prevents coagulation and subsequent solidification in the digestive tract and therefore promotes efficient absorption of the protein. Of all nutrition proteins, whey protein has the largest leucin content. Leucin is crucial for muscle protein synthesis. (Meyer RF, et.al.: BMC Gastroenterol 2015, 15), (Marik PE: Ann Intensive Care 2015,5:51)
Our previous observational data also showed that early overfeeding was associated with higher mortality, while an intake of 80-100% of measured energy expenditure at day 4 of ICU admission was associated with lower mortality. (Weijs PJM et. al., Critical Care 2014, 18)
Therefore, the energy target during the first four days will be 90% of the measured Energy Expenditure (EE). To optimize energy intake, the investigators will measure EE by metabolic monitoring (Deltatrac®, Datex, Helsinki, Finland), If metabolic monitoring is not available, the investigators will assess EE from the ventilator derived VCO2 (8.19*VCO2). (Stapel S, et.al., Critical Care 2015,19:370)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Admission to the intensive care unit
- •Age >18 years
- •Mechanical ventilation
- •Expected intensive care stay of four days or longer
排除标准
- •Contraindication for enteral nutrition (gut ischemia, obstruction or perforation)
- •Expected intolerance for enteral nutrition (paralytic ileus)
- •Inability to start enteral nutrition within 24-hours due to logistic reasons (i.e. surgery or other interventions)
- •Short bowel syndrome
- •Child C liver cirrhosis or acute liver failure
- •Dialysis dependency
- •Requiring other specific enteral nutrition for medical reason
- •Extensive treatment limitations
- •Written deferred patient or proxy consent is not obtained
- •Participation in another intervention study
- •Inability to measure energy expenditure (pulmonary air leakage)
结局指标
主要结局
The proportion of patients reaching the individualized protein target (≥1.2 g/kg ideal body weight/day) 96 hours after ICU admission
时间窗: 96 hours
Protein target
次要结局
- Plasma urea concentration (mmol/l)(48 and 96 hours)
- Plama leucine concentration (μmol/L)(0, 48, and 96 hours)
- Protein intake 48 hours and 96 hours after start (g/day)(48 and 96 hours)
- Number of patients with adverse events related to nutrition, as defined by: high gastric retention,abdominal distension, vomiting, diarrhea, need of prokinetics or duodenal tube(During 96 hours)
- Muscle mass (kg)(48 and 96 hours)
- Cumulative protein intake 96 hours after start of the study formula (grams)(96 hours)
- Time to protein target (protein intake ≥ 1.2 g/kg/day).(Up to 96 hours)
研究者
H.M. Oudemans-van Straaten, MD, PhD
Prof. Dr.
Amsterdam UMC, location VUmc