Hemodialysis Complication
Conditions
Brief summary
This study is aimed to demonstrate that increase in serum albumin concentration (week 8 -baseline) after test treatment (Fresubin® Protein Energy DRINK), a standard ONS, is not relevantly smaller than that after control treatment with NEPRO®.
Interventions
DIETARY_SUPPLEMENTFresubin® Protein Energy DRINK
1-2 bottles of Fresubin® Protein Energy DRINK per day
DIETARY_SUPPLEMENTNEPRO® , Abbott
2-4 cans NEPRO® per day
Sponsors
Chung Shan Medical University
Fresenius Kabi Taiwan Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 40-80 years 2. Acute or chronic renal failure patients who need dialysis and already dialysis for 3 months at least. 3. Malnutrition patients. Definition of Malnutrition is serum albumin level\<3.5g/dL, calorie digestion below 35kcal/IBW or protein digestion below 1.2g/IBW.
Exclusion criteria
1. BMI\<18.5 and calorie intake unable to reach 50% of the recommended level 2. BMI\>30 kg/m2, 3. abnormal liver function, 4. malignant disease, 5. scheduled surgery within a month or after surgery, 6. infectious disease, 7. suboptimal tolerance of nutritional supplements, 8. inflammatory bowel disease, bowel obstruction, 9. acute condition complicated with multiple organ failure or under palliative care.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum Albumin level change | baseline, weerk 4 and week 8 |
Secondary
| Measure | Time frame |
|---|---|
| Body Weight (kg) and Height(cm) change, and these results will be combine to report BMI (kg/m^2) change | baseline, weerk 4 and week 8 |
Countries
Taiwan
Outcome results
None listed