Oral Nutritional Supplementation of Hemodialysis Patients

Fresenius Kabi

Status: Completed

Conditions: Hemodialysis Complication

Treatments: Dietary Supplement: Fresubin® Protein Energy DRINK; Dietary Supplement: NEPRO® , Abbott

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05333692

FrPE-005-IEN

Details and patient eligibility

About

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®.

Enrollment: 90 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

NEPRO®

Active Comparator group

Treatment:

Dietary Supplement: NEPRO® , Abbott

Fresubin® Protein Energy DRINK

Experimental group

Treatment:

Dietary Supplement: Fresubin® Protein Energy DRINK