Long-term Muscle Synthetic Effects of Intradialytic Parenteral Nutrition in Chronic Hemodialysis Patients

NCT07254897 | Not Yet Recruiting

• 1 other identifier: 2025-522111-42-02
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study examines the effects of intradialytic parenteral nutrition (IDPN) on muscle growth and blood pressure in patients undergoing chronic hemodialysis.

Conditions

Malnutrition or Risk of Malnutrition

Keywords

hemodialysis; myofibrillar fractional synthetic rate; intradialytic parenteral nutrition

Outcome Measures

Primary Outcomes (1)

• Myofibrillar fractional synthetic rate

  Difference in myofibrillar fractional synthetic rate during treatment with IDPN versus usual care

  At baseline and during the first dialysis sessions in the following two weeks.

Secondary Outcomes (3)

• Forearm amino acid (AA) balance

  During the first visit in intervention and cross-over usual care regiment.

• Intradialytic blood pressure and cardiac output

  Cardiac output will be measured at baseline and during the first dialysis sesions in the following 2 weeks. Predialysis systolic blood pressure, intradialytic blood pressure decrease, and ultrafiltration volume will be measured at each dialysis session.

• Amino acid loss in dialysate

  Amino acid loss in dialysate will be measured during V2 and V5.

Study Arms (2)

intra dialytic parenteral nutrition (Olimel N12, Baxter, 1L/session)

EXPERIMENTAL

intra dialytic parenteral nutrition (Olimel N12, Baxter, 1L/session)

Dietary Supplement: intra dialytic parenteral nutrition (Olimel N12, Baxter, 1L/session)

Control

NO INTERVENTION

no intervention according to usual care

Interventions

intra dialytic parenteral nutrition (Olimel N12, Baxter, 1L/session) DIETARY_SUPPLEMENT

Olimel N12 is administered via the arteriovenous fistula. Olimel N12 is registered for parenteral use in day-care settings. The dose is 1000 mL (250 mL/h) per hemodialysis session.

intra dialytic parenteral nutrition (Olimel N12, Baxter, 1L/session)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age above 18 years
• Receiving HD treatment over 3 months
• Receiving HD treatment 3 times per week for at least 4 hours per session
• hour urine production \< 100 mL
• Adequate dialysis dose (eKt/V over 1.2)
• AV fistula with blood flow (measured invasively or by Doppler ultrasound) over 750 mL/min

You may not qualify if:

• Occurrence of intradialytic hypotension in the last month, defined by systolic blood pressure \< 90 mm Hg combined with a nursing intervention
• Active infection or inflammation at randomization
• Use of oral or intravenous corticosteroids
• Incapacitation
• Patients who are not expected to be able to complete the study protocol (e.g., due to a planned kidney transplantation within the planned study time frame)
• Pregnancy
• Use of oral anticoagulants or antiplatelet agents that cannot be safely stopped during the study
• Diabetes mellitus
• AV fistula with recirculation

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC

Rotterdam, 3015GD, Netherlands

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Central Study Contacts

Wesley J Visser, PhD

CONTACT

+31614285361; w.j.visser@erasmusmc.nl

Manon de Geus, MSc

CONTACT

+31650032488

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, PhD, RD

Model Details: Investigator-initiated intervention study with crossover design

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 28, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)