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Clinical Trials in the Netherlands / NCT04094038
Active, not recruiting Phase 4

The Effect of Intradialytic Parenteral Nutrition on Nutritional Status and Quality of Life in Hemodialysis Patients

NCT04094038 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Erasmus Medical Center
Phase
Phase 4
Started
2019-09-16
Last updated
2026-02-12

Condition(s) studied

End Stage Renal DiseaseMalnutritionSarcopeniaHemodialysis Complication

Investigational drug(s) / intervention(s)

Olimel N12Glucose IV

Olimel N12: A mixture of glucose, lipids, amino acids.

Glucose IV: Glucose 5%

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Undergoing chronic hemodialysis Exclusion Criteria: * Life expectancy \< 6 months * Planned kidney transplant within 4 months * Severe overhydration leading to respiratory insufficiency * Parenteral nutrition within four weeks prior to screening * Severe hepatic insufficiency * Pregnancy * Unipolar pacemaker with a very low sensitivity threshold * Active treatment for infection * Acute myocardial infarction * Circulatory shock * Hypersensitivity for any Olimel N12 ingredient or excipient

Primary outcome measure(s)

  • Change in lean tissue mass — 16 weeks
    Measured by body composition monitor (BCM)

Trial sites (2)

FacilityCityRegionStatus
Erasmus MC Rotterdam Netherlands
Franciscus Gasthuis & Vlietland Rotterdam Netherlands

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04094038 on ClinicalTrials.gov ↗ ← All trials in the Netherlands