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

Last updated: December 24, 2024
Sponsor: Erasmus Medical Center
Overall Status: Active - Not Recruiting

Phase

4

Condition

Sarcopenia

Diet And Nutrition

Weight Loss

Treatment

Olimel N12

Glucose IV

Clinical Study ID

NCT04094038
IDPN1
2018-003899-13
MEC-2018-1452
NL65803.078.18
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Undergoing chronic hemodialysis

Exclusion

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

Study Design

Total Participants: 166
Treatment Group(s): 2
Primary Treatment: Olimel N12
Phase: 4
Study Start date:
September 16, 2019
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • Erasmus MC

    Rotterdam,
    Netherlands

    Site Not Available

  • Franciscus Gasthuis & Vlietland

    Rotterdam,
    Netherlands

    Site Not Available

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