Oral Nutritional Supplementation of Hemodialysis Patients

Hemodialysis Complication Clinical Trial

Official title:

Oral Nutritional Supplementation of Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05333692
• Other study ID #: FrPE-005-IEN
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: May 6, 2021

Study information

• Verified date: April 2022
• Source: Fresenius Kabi Taiwan Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 6, 2021
• Est. primary completion date: May 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemodialysis Complication

Intervention

Dietary Supplement:
• Fresubin® Protein Energy DRINK
1-2 bottles of Fresubin® Protein Energy DRINK per day
• NEPRO® , Abbott
2-4 cans NEPRO® per day

Locations

Country	Name	City	State
Taiwan	Chung Shan Medical University	Taichung

Sponsors (2)

Lead Sponsor	Collaborator
Fresenius Kabi Taiwan Ltd.	Chung Shan Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Albumin level change		baseline, weerk 4 and week 8
Secondary	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