NCT04094038Active, not recruitingPhase 4
The Effect of Intradialytic Parenteral Nutrition on Nutritional Status and Quality of Life in Hemodialysis Patients
Source: ClinicalTrials.gov · Last updated 12 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 166 (estimated)
- First submitted
- 12 Sept 2019
- Start date
- 16 Sept 2019
- Primary completion date
- 2 Apr 2024
- Lead sponsor
- Erasmus Medical Center
- Diseases
- Chronic kidney disease
- NCT number
- NCT04094038
- EudraCT number
- 2018-003899-13
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 166
- From 16 Sept 2019 to the primary completion date, 2 Apr 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Planned kidney transplant within 4 months
- Parenteral nutrition within four weeks prior to screening
Other illness
- Severe overhydration leading to respiratory insufficiency
- Severe hepatic insufficiency
- Active treatment for infection
- Acute myocardial infarction
- Hypersensitivity for any Olimel N12 ingredient or excipient
Other
- Life expectancy \< 6 months
- Pregnancy
- Unipolar pacemaker with a very low sensitivity threshold
- Circulatory shock
Who the study is looking for
- Undergoing chronic hemodialysis
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Erasmus MC Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
| Franciscus Gasthuis & Vlietland Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.