Status:
ACTIVE_NOT_RECRUITING
The Effect of Intradialytic Parenteral Nutrition on Nutritional Status and Quality of Life in Hemodialysis Patients
Lead Sponsor:
Erasmus Medical Center
Collaborating Sponsors:
Baxter Healthcare Corporation
Conditions:
End Stage Renal Disease
Malnutrition
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 c...
Eligibility Criteria
Inclusion
- Undergoing chronic hemodialysis
Exclusion
- 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
Key Trial Info
Start Date :
September 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT04094038
Start Date
September 16 2019
End Date
September 1 2025
Last Update
December 27 2024
Active Locations (2)
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1
Erasmus MC
Rotterdam, Netherlands
2
Franciscus Gasthuis & Vlietland
Rotterdam, Netherlands