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Study of Intradialytic Parenteral Nutrition for Muscle Protein Production in Patients on Long-term Hemodialysis Treatment

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study looks at muscle protein turnover in people who receive hemodialysis, which is a treatment that filters waste and extra fluid from the blood when the kidneys can no longer do this job properly. Patients who need hemodialysis often have problems maintaining their muscle mass, which can affect their strength and overall health. The study will use a treatment called intradialytic parenteral nutrition, which means giving liquid nutrition directly into the bloodstream during the dialysis session. This nutrition solution contains various amino acids, which are the building blocks of proteins, along with glucose for energy and minerals like calcium, magnesium, and potassium that the body needs to function properly.

The purpose of the study is to see how this nutrition given during dialysis affects the way muscles build new proteins and to understand how it affects blood pressure and heart function during the dialysis treatment. The study will compare periods when patients receive the nutrition solution during dialysis with periods when they do not receive it. During the study, researchers will measure how quickly the muscles make new proteins and will track the levels of amino acids in the blood and in the fluid removed during dialysis. They will also monitor blood pressure and how well the heart is pumping blood throughout the treatment sessions.

Participants will undergo dialysis sessions three times per week as they normally would, but during some weeks they will receive the additional nutrition through their dialysis access point. The study will involve taking blood samples and measuring various aspects of muscle and heart function. The research will last for several weeks for each participant, allowing researchers to compare the effects of receiving nutrition during dialysis versus not receiving it. This information will help doctors understand whether giving nutrition during dialysis can help hemodialysis patients maintain or improve their muscle health.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Administration of nutrition during dialysis

    A parenteral nutrition solution, which is a mixture of nutrients delivered directly into the bloodstream, is administered during hemodialysis sessions.

    The solution contains a combination of amino acids, which are the building blocks of protein, along with minerals and glucose to support muscle protein synthesis (the process of building muscle tissue).

  2. Step 2

    Treatment monitoring and evaluation

    The effects of the intradialytic parenteral nutrition are monitored by measuring the fractional synthetic rate, which indicates how quickly muscle tissue is being built.

    Observations are made regarding the amino acid balance in the forearm and the amount of nutrients lost in the dialysate (the fluid used during the dialysis process) over a one-week treatment period.

    Changes in blood pressure and cardiac output (the amount of blood the heart pumps) are recorded to assess the impact of the nutrition on the circulatory system.

Who can join the trial?

6 criteria

  • You must be at least 18 years old.
  • You must have been receiving hemodialysis, which is a medical treatment that uses a machine to clean your blood when your kidneys can no longer do it on their own, for at least 3 months.
  • Your hemodialysis sessions must occur 3 times per week, and each session must last at least 4 hours.
  • Your total amount of urine production (the amount of liquid your body creates through your bladder) must be less than 100 mL over a 24-hour period.
  • You must receive an adequate dialysis dose, which means your treatment is effectively cleaning your blood; this is measured by a value called eKt/V that must be at least 1.2.
  • You must have an AV fistula, which is a special connection made between an artery and a vein to allow blood to flow easily during treatment, with a blood flow rate of at least 750 mL/min as measured by a doctor.

Who cannot join the trial?

10 criteria

  • Having experienced intradialytic hypotension, which means a sudden drop in blood pressure during a dialysis treatment, where the top number of the blood pressure reading fell below 90 and required help from a nurse, within the last month.
  • Being admitted to the hospital less than 3 months before starting the study.
  • Having an active infection (an illness caused by germs like bacteria or viruses) or inflammation (the body's response to injury or irritation, often causing swelling or redness) at the time of joining the study.
  • Using corticosteroids, which are powerful medicines used to reduce swelling or suppress the immune system, whether taken by mouth or through a vein.
  • Being incapacitated, which means being unable to take care of oneself or carry out normal activities.
  • Being unable to finish the entire study process, such as if a kidney transplantation (a surgery to replace a failed kidney with a healthy one) is already planned.
  • Being pregnant.
  • Taking oral anticoagulants (blood-thinning pills) or antiplatelet agents (medicines that prevent blood cells from sticking together) that cannot be safely stopped during the study.
  • Having diabetes mellitus, a condition where the body has trouble managing blood sugar levels.
  • Having an AV fistula with recirculation, which occurs when blood flows through the surgically created connection used for dialysis and then loops back into the machine instead of flowing through the body.
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Investigated drugs

Intradialytic parenteral nutrition is a mixture of essential amino acids (the building blocks of protein), minerals, and glucose that is given directly into the bloodstream through a vein during a hemodialysis session. This therapy is used to provide necessary nutrients to help support muscle health and protein production in patients undergoing dialysis.

What is already known about the treatment

Intradialytic Parenteral Nutrition - This medication is administered through a vein during a hemodialysis session to provide essential nutrients directly into the bloodstream. It is an intravenous nutritional supplement used to help manage malnutrition in patients undergoing regular kidney dialysis. The mixture works by supplying a precise blend of amino acids, vitamins, and minerals that the body uses as building blocks to create new muscle tissue and maintain protein levels. This combination is classified as a parenteral nutrition solution designed to support metabolic health when oral intake is insufficient.

Investigated diseases

Chronic kidney disease requiring hemodialysis - This condition occurs when the kidneys can no longer function effectively to filter waste and excess fluids from the blood. To manage the buildup of toxins, patients undergo hemodialysis, a process where an external machine cleans the blood. During this procedure, various substances in the blood are filtered out. This process can impact the balance of nutrients and proteins within the body. Over time, the body may experience changes in how it maintains muscle mass and manages amino acids.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522111-42-02Estimated enrolment20 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

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