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

NCT ID: NCT07254897

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-09-01

Brief Summary

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

Detailed Description

Rationale: Malnutrition and a negative protein balance are highly prevalent in hemodialysis (HD) patients. In these patients, nutritional status and body composition are closely linked to morbidity, mortality, and quality of life. Muscle wasting in HD patients is the result of poor intake, anabolic resistance and the intradialytic loss of amino acids, leading to a negative protein balance. Intradialytic parenteral nutrition (IDPN) has been shown to reverse this anabolic state in the short term (a single dialysis session) in studies using primed constant infusion of isotope-labeled amino acids. However, such studies were carried out in fasted state, which may significantly overestimate the effect. Moreover, they provide no insight in muscle synthesis over longer periods of time, including the interdialytic interval and across multiple dialysis sessions. The use of deuterated water (2H2O) enables longer-term assessment of muscle protein synthesis in an outpatient setting. The administration of IDPN, due to its volume, may have intradialytic hemodynamic effects, which have not been characterized in previous studies.

Objective: To study the effect of IDPN on muscle protein synthesis in chronic hemodialysis patients and to characterize the hemodynamic effects of IDPN.

Study design: Investigator-initiated intervention study with crossover design.

Study population: Chronic hemodialysis patients aged over 18 years (dialysis vintage over 3 months).

Intervention: IDPN (Olimel N12, Baxter, 1L/session) or regular care without IDPN.

Main study parameters/endpoints: Difference in myofibrillar fractional synthetic rate during a one-week treatment with IDPN versus one control week consisting of regular care.

Data collection: The study includes a maximum of 9 study visits, which will take place during regular hemodialysis sessions. These may include non-invasive measurements such as bioimpedance spectroscopy, measurements of cardiac output, blood sampling (for which venepuncture), three percutaneous muscle biopsies (vastus lateralis), food intake registration, collection of dialysate, handgrip strength and activity levels.

Conditions

Malnutrition or Risk of Malnutrition

Keywords

hemodialysis; myofibrillar fractional synthetic rate; intradialytic parenteral nutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Control

no intervention according to usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Age above 18 years
• Receiving HD treatment over 3 months
• Receiving HD treatment 3 times per week for at least 4 hours per session
• 24-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

Exclusion Criteria

• Occurrence of intradialytic hypotension in the last month, defined by systolic blood pressure < 90 mm Hg combined with a nursing intervention
• Hospitalization < 3 months before inclusion
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Dr. Wesley Visser

Principal investigator, PhD, RD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Erasmus MC

Rotterdam, , Netherlands

Countries

Netherlands

Central Contacts

Wesley J Visser, PhD

Role: CONTACT

Phone: +31614285361

Email: w.j.visser@erasmusmc.nl

Manon de Geus, MSc

Role: CONTACT

Phone: +31650032488

Other Identifiers

2025-522111-42-02

Identifier Type: CTIS

Identifier Source: secondary_id

2025-522111-42-02

Identifier Type: -

Identifier Source: org_study_id