Clinical Trial

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

Active, Not Recruiting Phase 4

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.

Protocol Amendment History 4 amendments

This ClinicalTrials.gov record has been amended 4 times since 2019-09-16; most recent amendment 2026-02-10.

Status change: Recruiting → Active, Not Recruiting 2024-12-24

Status change: Not Yet Recruiting → Recruiting 2020-01-28

Trial Details

NCT Number	NCT04094038
Lead Sponsor	Erasmus Medical Center Collaborators: Baxter Healthcare Corporation
Conditions	End Stage Renal Disease, Malnutrition, Sarcopenia, Hemodialysis Complication
Enrollment	166 participants
Start Date	2019-09-16
Primary Completion	2024-04-02 (estimated)
Study Completion	2026-07 (estimated)
Updated on ClinicalTrials.gov	2026-02-12