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.

Study Overview

• Status: Recruiting
• Conditions: Malnutrition; End Stage Renal Disease; Hemodialysis Complication; Sarcopenia
• Intervention / Treatment: Drug: Olimel N12; Drug: Glucose IV

• Study Type: Interventional
• Enrollment (Anticipated): 166
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: David Severs, MD; Phone Number: +31107040704; Email: d.severs@erasmusmc.nl

Study Locations

• Netherlands
  • Rotterdam, Netherlands
    • Recruiting
    • Erasmus MC
    • Contact: Ewout J Hoorn; Phone Number: +31107040704
    • Sub-Investigator: David Severs, MD
    • Sub-Investigator: Wesley Visser, RD
  • Rotterdam, Netherlands
    • Recruiting
    • Franciscus Gasthuis & Vlietland
    • Contact: Martine Verhoeven, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Intradialytic parenteral nutrition three times weekly during 16 weeks	Drug: Olimel N12; A mixture of glucose, lipids, amino acids.
Placebo Comparator: Placebo; 5% glucose three times weekly during 16 weeks	Drug: Glucose IV; Glucose 5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in lean tissue mass	Measured by body composition monitor (BCM)	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skeletal muscle quality index (SMQI)	Assessed by muscle ultrasound	16 weeks
Change in adipose tissue mass from baseline		16 weeks
Change in hand grip strength from baseline	Measured by hand dynamometer, expressed as percentile of reference (by age and gender)	16 weeks
Change in kidney disease quality of life (KDQoL-36) energy/fatigue scale from baseline	Assessed by Kidney Disease Quality of Life-36 (KDQoL-36) survey (energy/fatigue scale, 0-100, higher is better)	16 weeks
Change in kidney disease quality of life (KDQoL-36, overall health rating) from baseline	Assessed by Kidney Disease Quality of Life-36 (KDQoL-36) survey (0-100, higher is better)	16 weeks
Positive and negative affect	Assessed by Positive and Negative Affect Schedule (PANAS, 0-100, higher is better)	16 weeks
Change in phase angle from baseline	Assessed by Body Composition Monitor (BCM)	16 weeks
Change in body weight from baseline		16 weeks
Change in serum prealbumin concentration from baseline		16 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective global assessment (SGA)	7-point scale, 7 indicates normal nutritional status, 1 indicates severe protein energy wasting	16 weeks
Change in serum albumin concentration		16 weeks
Appetite	Numeric rating scale (0-10, 10 being best appetite)	16 weeks

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: Baxter Healthcare Corporation
• Investigators: Principal Investigator: Ewout J Hoorn, MD PhD, Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2019
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: September 12, 2019
• First Submitted That Met QC Criteria: September 16, 2019
• First Posted (Actual): September 18, 2019

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Kidney Diseases; Urologic Diseases; Neurologic Manifestations; Renal Insufficiency; Nutrition Disorders; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Renal Insufficiency, Chronic; Muscular Atrophy; Atrophy; Kidney Failure, Chronic; Sarcopenia; Malnutrition
• Other Study ID Numbers: IDPN1; 2018-003899-13 (EudraCT Number); NL65803.078.18 (Other Identifier: Central Commission for Human Research (CCMO)); MEC-2018-1452 (Other Identifier: Erasmus MC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No