The Effects of Enteral Whey Protein Supplement on Serum Albumin Level in Acute Critically Ill Neurological Patients

The purpose of the study is to compare standard enteral nutrition regimen with the enteral nutrition regimen supplemented with whey protein in severe neurological disease patients and to observe nutritional indicators improvement in these patients. A total of 116 subjects will be included. Counting process is as follows: referring available literature and the mean value of serum albumin in patients on the 14th day of our preliminary tests, and the difference test is used to compare the mean values of two independent samples. The ratio of the experimental group and control group is 1:1. It was assumed that the serum albumin level in the experimental group was higher than that in the control group. A single end is taken, α=0.05, 1-β=0.80, experimental group patients serum albumin（Χ±S）=37.9±5.1, the control group serum albumin（Χ±S）=35.6±4.8, so the total sample size was 116.It was estimated that 116 patients were enrolled consecutively, which were divided into experimental group and control group by computer generated random number table. Patients in both groups received enteral nutrition therapy with continuous tube feeding for 14 days. According to the nutritional treatment requirements of critically ill patients in the Asia-Pacific region in 2016, patients with severe acute stress were given energy demand for 25\~30kcal/kg/d, protein demand for 1.2\~2g/kg/d and other standardized clinical treatments. Control group nutrition program: standardized enteral nutrition preparation only. Experimental group nutrition program: whey protein powder was added on the basis of standardized enteral nutrition preparation. According to the body weight of the patients, different enteral nutritional preparations and dose adjustments were selected to ensure that the calorie and protein intake of the two groups of patients met the above nutritional treatment requirements.Primary endpoint: serum albumin level at 14 days of enteral nutrition. Secondary end points: 1. APACHE II, GCS and other clinical scores at 14 days; 2. total serum protein, proalbumin, hemoglobin and other nutritional indicators; 3. the number and ratio of white blood cells, neutrophils, c-reactive protein, interleukin-6, procalcitonin, absolute count of T lymphocyte subsets, immunoglobulin and other inflammatory indicators at 14 days; 4. the number of cases of gastrointestinal complications such as gastric retention, vomiting, diarrhea, abdominal distention, constipation and gastrointestinal bleeding during the 14 days of enteral nutrition; 5. the number of patients with serum albumin < 30g/L within 14 days after admission.