Malnutrition or Risk of MalnutritionLOTUSNCT07254897
Long-term Muscle Synthetic Effects of Intradialytic Parenteral Nutrition in Chronic Hemodialysis Patients
A study testing intra dialytic parenteral nutrition (Olimel N12, Baxter, 1L/session) in people with Malnutrition or Risk of Malnutrition, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
This study examines the effects of intradialytic parenteral nutrition (IDPN) on muscle growth and blood pressure in patients undergoing chronic hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition or Risk of Malnutrition
- What is being tested?
- intra dialytic parenteral nutrition (Olimel N12, Baxter, 1L/session)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2026to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- Pregnancy
- Use of oral anticoagulants or antiplatelet agents that cannot be safely stopped during the study
- Diabetes mellitus
- AV fistula with recirculation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Manon de Geus, MSc contact
About this study
This study examines the effects of intradialytic parenteral nutrition (IDPN) on muscle growth and blood pressure in patients undergoing chronic hemodialysis.
Read the 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
- Being tested
- intra dialytic parenteral nutrition (Olimel N12, Baxter, 1L/session)
- Keywords
- hemodialysis, myofibrillar fractional synthetic rate, intradialytic parenteral nutrition
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| intra dialytic parenteral nutrition (Olimel N12, Baxter, 1L/session) | Experimental | intra dialytic parenteral nutrition (Olimel N12, Baxter, 1L/session) Receives: Dietary Supplement: intra dialytic parenteral nutrition (Olimel N12, Baxter, 1L/session) |
| Control | No intervention | no intervention according to usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myofibrillar fractional synthetic rate
Difference in myofibrillar fractional synthetic rate during treatment with IDPN versus usual care
Measured: At baseline and during the first dialysis sessions in the following two weeks.
Secondary outcomes (3)
Forearm amino acid (AA) balance
A cannula is placed in the antecubital vein of the arm opposite the hemodialysis AV fistula. Blood is drawn before hemodialysis, after 2 hours, and at the end of the session from both the cannula (draining forearm musculature) and the "arterial" needle in the AV fistula (representing arterial blood). The "venous" needle is used for infusion. Blood flow and recirculation are checked to prevent mixing of IDPN/placebo-infused blood. Comparing amino acid concentrations before and after the forearm musculature reveals the net uptake or release from the arm.
Measured: During the first visit in intervention and cross-over usual care regiment.
Intradialytic blood pressure and cardiac output
Cardiac output can be estimated noninvasively by the Starling Monitor (Baxter). This method relies on bioreactance measured by 4 electrodes placed on the patient's chest. By employing this method, cardiac output can be measured continuously with no disruption to the treatment and no discomfort to the patient. Predialysis systolic blood pressure, intradialytic blood pressure decrease, and ultrafiltration volume will be assessed.
Measured: 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
During hemodialysis, some AA are lost in the dialysate. This amount is likely to increase during IDPN, given the significantly elevated plasma AA concentrations during this treatment. To quantify this, we will collect all spent dialysate in a specially constructed collection device.
Measured: Amino acid loss in dialysate will be measured during V2 and V5.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnutrition or Risk of MalnutritionStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Investigator-initiated intervention study with crossover design
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Wesley Visser, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254897
- Sponsor's protocol ID
- 2025-522111-42-02
- Other IDs
- 2025-522111-42-02, 2025
- Acronym
- LOTUS
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Muscle Synthetic Effects of Intradialytic Parenteral Nutrition in Chronic Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT07254897
- Acronym / sponsor ID
- LOTUS / 2025-522111-42-02
- Conditions
- Malnutrition or Risk of Malnutrition
- Keywords
- hemodialysis, myofibrillar fractional synthetic rate, intradialytic parenteral nutrition
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Investigator-initiated intervention study with crossover design
| Arm | Type | Receives |
|---|---|---|
| intra dialytic parenteral nutrition (Olimel N12, Baxter, 1L/session) | Experimental | Dietary Supplement: intra dialytic parenteral nutrition (Olimel N12, Baxter, 1L/session)intra dialytic parenteral nutrition (Olimel N12, Baxter, 1L/session) |
| Control | No intervention | –no intervention according to usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | intra dialytic parenteral nutrition (Olimel N12, Baxter, 1L/session) |
Primary outcome
Myofibrillar fractional synthetic rate
Time frame: At baseline and during the first dialysis sessions in the following two weeks.
Difference in myofibrillar fractional synthetic rate during treatment with IDPN versus usual care
3 secondary outcomes
Forearm amino acid (AA) balance
Time frame: During the first visit in intervention and cross-over usual care regiment.
Intradialytic blood pressure and cardiac output
Time frame: 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
Time frame: Amino acid loss in dialysate will be measured during V2 and V5.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Manon de Geus, MSc contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intra dialytic parenteral nutrition (Olimel N12, Baxter, 1L/session) in people with Malnutrition or Risk of Malnutrition, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wesley J Visser, PhD (+31614285361, w.j.visser@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myofibrillar fractional synthetic rate (time frame: At baseline and during the first dialysis sessions in the following two weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.