NCT07254897

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-06-01
• Completion: 2027-09-01
• First posted: 2025-11-28
• Last updated: 2025-11-28

Locations

1 site across 1 country: Netherlands