The Effect of Intradialytic Parenteral Nutrition on Nutritional Status and Quality of Life in Hemodialysis Patients
NCT04094038 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 166
Last updated 2026-02-12
Summary
Protein-energy wasting (PEW), a hypercatabolic state characterized by loss of muscle mass and fuel reserves, is highly prevalent in hemodialysis patients. Nutritional status and body composition are closely linked to morbidity, mortality and quality of life. Lean tissue mass (LTM) appears to be the best read-out for the association between nutritional status and outcomes. Intradialytic parenteral nutrition (IDPN) is occasionally used with the aim to reduce loss of LTM, but its efficacy has not been established. The goal of this study is to study the effect of IDPN on changes in LTM in hemodialysis patients.
Conditions
- End Stage Renal Disease
- Malnutrition
- Sarcopenia
- Hemodialysis Complication
Interventions
- DRUG
-
Olimel N12
A mixture of glucose, lipids, amino acids.
- DRUG
-
Glucose IV
Glucose 5%
Sponsors & Collaborators
-
Baxter Healthcare Corporation
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Ewout J Hoorn, MD PhD · Erasmus Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-09-16
- Primary Completion
- 2024-04-02
- Completion
- 2026-07-31
Countries
- Netherlands
Study Locations
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