This study examines the effects of intradialytic parenteral nutrition (IDPN) on muscle growth and blood pressure in patients undergoing chronic hemodialysis.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
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.
Erasmus MC
Rotterdam, Netherlands
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.
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.
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.
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.
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Time frame: Amino acid loss in dialysate will be measured during V2 and V5.