Active — Not RecruitingPhase 4

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

Netherlands166 participantsStarted 2019-09-16

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Change in lean tissue mass

Timeframe: 16 weeks

Trial details

NCT IDNCT04094038

SponsorErasmus Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-02

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