Intradialytic parenteral nutrition in maintenance hemodialysis patients suffering from protein-energy wasting. Results of a multicenter, open, prospective, randomized trial

Abstract

Background & aims: Protein-energy wasting (PEW) is increasingly becoming a clinical problem in maintenance hemodialysis patients and guidelines call for nutritional interventions. Serum prealbumin (transthyretin) represents a critical nutritional marker positively correlated with patient survival and negatively correlated with morbidity. Nutritional counseling, oral supplementation as well as intradialytic parenteral nutrition (IDPN) are recommended to fight PEW, however clinical trials on their use are scarce. Methods: We conducted a prospective, multicenter, randomized, open-label, controlled, parallel-group Phase IV clinical trial in 107 maintenance hemodialysis patients suffering from PEW to assess the impact of IDPN on prealbumin and other biochemical and clinical parameters reflecting nutritional status. Patients randomized to the intervention group received standardized nutritional counseling plus IDPN three times weekly over 16 weeks followed by a treatment-free period of 12 weeks. The control group received standardized nutritional counseling only. Main trial inclusion criteria included moderate to severe malnutrition (SGA score B or C), maintenance hemodialysis therapy (3 times per week) for more than six months, and presence of two out of the following three criteria: albumin <35 g/L, prealbumin <250 mg/L, phase angle alpha <4.5 assessed by bioelectrical impedance analysis (BIA). Changes in serum prealbumin, albumin, transferrin, phase angle alpha, subjective global assessment (SGA) score and health-related quality of life using the 12-item short form health survey (SF-12) were investigated. Results: IDPN significantly increased prealbumin (p < 0.05), showing rapid rise within 16 weeks of treatment and sustained response thereafter. In the full analysis set (n ¼ 83), 41.0% of 39 patients receiving IDPN achieved a relevant (i.e., at least !15%) increase in prealbumin over baseline at week 4 compared to 20.5% of 44 patients in the control group. Considerably more patients with IDPN therapy achieved an increment of prealbumin >30 mg/L at week 16 (48.7% vs. 31.8%). Prealbumin response to IDPN therapy was more prominent in patients suffering from moderate malnutrition (SGA score B) compared to patients with severe malnutrition (SGA score C). Conclusions: The results of this trial demonstrate for the first time that IDPN therapy, given three times weekly in a 16-week short-term intervention, results in a statistically significant and clinically relevant

Use of Intradialytic Parenteral Nutrition in Patients Undergoing Hemodialysis

“…Several retrospective and prospective randomized studies have examined the effects of IDPN on clinical end points. Benefits noted included improvements in anthropometric parameters and serum albumin and serum prealbumin albumin levels . One human study that infused stable isotopes to assess muscle turnover during IDPN identified increases in regional and total body protein synthesis .…”

Intradialytische Ernährung – Oral? Enteral? Parenteral?

“…In der Normalbevölkerung käme bei Erfolglosigkeit der bisherigen Maßnahmen als nächste Stufe die supportive künstliche Ernährung zum Beispiel über eine PEG-Sonde, welche einen wenn auch kleinen -Eingriff erfordert. Diese Maßnahme ist auch für Dialysepatienten in den EBPG [13] Für die intradialytische parenterale Ernährung konnte Marsen [15] im Vergleich zur Ernährungsberatung allein einen deutlichen Anstieg von Präalbuminals Surrogatparameter für einen gebesserten Ernährungsstatusinnerhalb 16 Wochen zeigen. Die Metaanalyse von Bossola et al [16] bescheinigte der IDPE eine Zunahme von Gewicht, Lean Body Mass, Serumalbumin und Serumpräalbumin.…”

Dietary protein and nutritional supplements in conventional hemodialysis

“…IDPN is not to be intended as a long‐lasting therapy; in fact, ONS should be restarted and IDPN should be discontinued as soon as possible based on the combination of three of the following criteria: stable serum albumin >3.8 mg/dL for 3 months; improvement in subjective global assessment (SGA) score to A (well‐nourished) or B (moderately malnourished); clinical examination of improved nutritional status; increase in protein and energy oral intake to >1.0 g/kg/d and to >30 kcal/kg/d . Despite the lack of studies demonstrating any benefit of IDPN on mortality, there is convincing evidence about its positive effects on nitrogen balance, anthropometric parameters and serum prealbumin, a surrogate parameter for hard outcomes in malnourished hemodialysis patients . Such early benefits of IDPN can be identified as soon as after 1 month of treatment when prealbumin is monitored .…”

“…Despite the lack of studies demonstrating any benefit of IDPN on mortality, there is convincing evidence about its positive effects on nitrogen balance, anthropometric parameters and serum prealbumin, a surrogate parameter for hard outcomes in malnourished hemodialysis patients . Such early benefits of IDPN can be identified as soon as after 1 month of treatment when prealbumin is monitored . A recent but small, randomized, controlled trial designed to evaluate the efficacy of IDPN therapy in malnourished patients with refractory anemia suggested an improvement in nutritional status assessed by the malnutrition inflammation score (MIS), BMI and albumin, as well as an improvement in refractory anemia .…”

“…12 Such early benefits of IDPN can be identified as soon as after 1 month of treatment when prealbumin is monitored. 67 A recent but small, randomized, controlled trial designed to evaluate the efficacy of IDPN therapy in malnourished patients with refractory anemia suggested an improvement in nutritional status assessed by the malnutrition inflammation score (MIS), BMI and albumin, as well as an improvement in refractory anemia. 68 Despite its possible risks that must be take into consideration (Figure 3), IDPN seems to be metabolically safe.…”