Oral Nutritional Supplementation of Hemodialysis Patients

Not Applicable

Completed

• Conditions: Hemodialysis Complication
• Interventions: Dietary Supplement: NEPRO® , Abbott; Dietary Supplement: Fresubin® Protein Energy DRINK

• 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

Study Timeline

• Study Start: 2020-07-01
• Primary Completion: 2021-05-06
• Study Completion: 2021-05-06
• Status Verified: 2022-04
• Study First Submitted: 2022-04-07
• Study First Submitted QC: 2022-04-17
• Last Update Submitted: 2022-04-17
• Study First Posted: 2022-04-19
• Last Update Posted: 2022-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NEPRO®	NEPRO® , Abbott	-
Fresubin® Protein Energy DRINK	Fresubin® Protein Energy DRINK	-

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

Trial Locations

Locations (1)

Chung Shan Medical University; 🇨🇳 Taichung, Taiwan