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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorErasmus Medical Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

16 Participants
are divided into 2 treatment groups
Group A: intra dialytic parenteral nutrition (Olimel N12, Baxter, 1L/session)Experimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Myofibrillar fractional synthetic rate

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

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

Secondary outcomes

1

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.

Time frame
During the first visit in intervention and cross-over usual care regiment.
2

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.

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.
3

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.

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

Other outcomes

Sponsors and contacts

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