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 volunteersQualifiers
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
Crossover
Treatments tested in this trial
intra dialytic parenteral nutrition (Olimel N12, Baxter, 1L/session)
Dietary supplementOlimel 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
Trial outcomes
Primary outcomes
Myofibrillar fractional synthetic rate
Difference in myofibrillar fractional synthetic rate during treatment with IDPN versus usual care
Secondary outcomes
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.
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.
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.
Sponsors and contacts
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