Oral Nutritional Supplementation of Hemodialysis Patients
Not Applicable
Completed
- Conditions
- Hemodialysis Complication
- Registration Number
- NCT05333692
- Lead Sponsor
- Fresenius Kabi Taiwan Ltd.
- 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®.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
- Age 40-80 years
- Acute or chronic renal failure patients who need dialysis and already dialysis for 3 months at least.
- 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
- BMI<18.5 and calorie intake unable to reach 50% of the recommended level
- BMI>30 kg/m2,
- abnormal liver function,
- malignant disease,
- scheduled surgery within a month or after surgery,
- infectious disease,
- suboptimal tolerance of nutritional supplements,
- inflammatory bowel disease, bowel obstruction,
- acute condition complicated with multiple organ failure or under palliative care.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Serum Albumin level change baseline, weerk 4 and week 8
- Secondary Outcome Measures
Name Time Method 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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie serum albumin increase in hemodialysis patients with nutritional supplementation?
How does Fresubin® Protein Energy DRINK compare to NEPRO® in improving nutritional status of hemodialysis patients?
Which biomarkers correlate with response to oral nutritional supplements in chronic kidney disease patients on hemodialysis?
What adverse events are associated with high-protein oral nutritional supplementation in end-stage renal disease?
Are there combination therapies with NEPRO® or Fresubin® that enhance outcomes in hemodialysis-related malnutrition?
Trial Locations
- Locations (1)
Chung Shan Medical University
🇨🇳Taichung, Taiwan
Chung Shan Medical University🇨🇳Taichung, Taiwan