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Active, Not Recruiting

NCT Number: NCT04094038

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

End Stage Renal Disease Atrophy Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemodialysis Complication Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Malnutrition Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Sarcopenia Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Erasmus MC, Rotterdam, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olimel N12

Drug

A mixture of glucose, lipids, amino acids.

Glucose IV

Drug

Glucose 5%

Primary outcomes

  1. Change in lean tissue mass

    Time frame: 16 weeks

    Measured by body composition monitor (BCM)

Secondary outcomes

  1. Skeletal muscle quality index (SMQI)

    Time frame: 16 weeks

    Assessed by muscle ultrasound

  2. Change in adipose tissue mass from baseline

    Time frame: 16 weeks

  3. Change in hand grip strength from baseline

    Time frame: 16 weeks

    Measured by hand dynamometer, expressed as percentile of reference (by age and gender)

  4. Change in kidney disease quality of life (KDQoL-36) energy/fatigue scale from baseline

    Time frame: 16 weeks

    Assessed by Kidney Disease Quality of Life-36 (KDQoL-36) survey (energy/fatigue scale, 0-100, higher is better)

  5. Change in kidney disease quality of life (KDQoL-36, overall health rating) from baseline

    Time frame: 16 weeks

    Assessed by Kidney Disease Quality of Life-36 (KDQoL-36) survey (0-100, higher is better)

  6. Positive and negative affect

    Time frame: 16 weeks

    Assessed by Positive and Negative Affect Schedule (PANAS, 0-100, higher is better)

  7. Change in phase angle from baseline

    Time frame: 16 weeks

    Assessed by Body Composition Monitor (BCM)

  8. Change in body weight from baseline

    Time frame: 16 weeks

  9. Change in serum prealbumin concentration from baseline

    Time frame: 16 weeks

Other outcomes

  1. Subjective global assessment (SGA)

    Time frame: 16 weeks

    7-point scale, 7 indicates normal nutritional status, 1 indicates severe protein energy wasting

  2. Change in serum albumin concentration

    Time frame: 16 weeks

  3. Appetite

    Time frame: 16 weeks

    Numeric rating scale (0-10, 10 being best appetite)

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

  • Baxter Healthcare Corporation

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2026
First posted
Sep 18, 2019
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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