Status:
COMPLETED
Oral Nutritional Supplementation of Hemodialysis Patients
Lead Sponsor:
Fresenius Kabi Taiwan Ltd.
Collaborating Sponsors:
Chung Shan Medical University
Conditions:
Hemodialysis Complication
Eligibility:
All Genders
40-80 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 6 2021
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05333692
Start Date
July 1 2020
End Date
May 6 2021
Last Update
April 19 2022
Active Locations (1)
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1
Chung Shan Medical University
Taichung, Taiwan, 40201