Oral Nutritional Supplementation of Hemodialysis Patients

Fresenius Kabi Taiwan Ltd.90 enrolled

Overview

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®.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hemodialysis Complication

Interventions

Fresubin® Protein Energy DRINKDIETARY_SUPPLEMENT

1-2 bottles of Fresubin® Protein Energy DRINK per day

NEPRO® , AbbottDIETARY_SUPPLEMENT

2-4 cans NEPRO® per day

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Chung Shan Medical University

Taichung, Taiwan

Outcomes

Primary Outcomes

Serum Albumin level change

Time frame: baseline, weerk 4 and week 8

Secondary Outcomes

Body Weight (kg) and Height(cm) change, and these results will be combine to report BMI (kg/m^2) change

Time frame: baseline, weerk 4 and week 8

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.