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Intradialytic parenteral nutrition in maintenance hemodialysis patients suffering from protein-energy wasting. Results of a multicenter, open, prospective, randomized trial.
Clin Nutr 2017; 36(1):107-117CN

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 = 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 increase in mean serum prealbumin, a surrogate marker for outcome and survival in hemodialysis patients suffering from PEW, and is superior to nutritional counseling. Clinical trial registry:www.clinicaltrials.gov (NCT00501956).

Authors+Show Affiliations

Nephrologische Schwerpunktpraxis und KfH-Nierenzentrum Köln-Lindenthal, Köln, Germany.Fresenius Kabi Deutschland GmbH, Bad Homburg, Germany.Institut für angewandte Nephrologie e.V., Aachen, Germany.No affiliation info available

Pub Type(s)

Clinical Trial, Phase IV
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26708726

Citation

Marsen, Tobias A., et al. "Intradialytic Parenteral Nutrition in Maintenance Hemodialysis Patients Suffering From Protein-energy Wasting. Results of a Multicenter, Open, Prospective, Randomized Trial." Clinical Nutrition (Edinburgh, Scotland), vol. 36, no. 1, 2017, pp. 107-117.
Marsen TA, Beer J, Mann H, et al. Intradialytic parenteral nutrition in maintenance hemodialysis patients suffering from protein-energy wasting. Results of a multicenter, open, prospective, randomized trial. Clin Nutr. 2017;36(1):107-117.
Marsen, T. A., Beer, J., & Mann, H. (2017). Intradialytic parenteral nutrition in maintenance hemodialysis patients suffering from protein-energy wasting. Results of a multicenter, open, prospective, randomized trial. Clinical Nutrition (Edinburgh, Scotland), 36(1), pp. 107-117. doi:10.1016/j.clnu.2015.11.016.
Marsen TA, et al. Intradialytic Parenteral Nutrition in Maintenance Hemodialysis Patients Suffering From Protein-energy Wasting. Results of a Multicenter, Open, Prospective, Randomized Trial. Clin Nutr. 2017;36(1):107-117. PubMed PMID: 26708726.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Intradialytic parenteral nutrition in maintenance hemodialysis patients suffering from protein-energy wasting. Results of a multicenter, open, prospective, randomized trial. AU - Marsen,Tobias A, AU - Beer,Justinus, AU - Mann,Helmut, AU - ,, Y1 - 2015/12/12/ PY - 2015/05/29/received PY - 2015/11/18/revised PY - 2015/11/23/accepted PY - 2015/12/29/pubmed PY - 2018/3/1/medline PY - 2015/12/29/entrez KW - IDPN KW - Intradialytic parenteral nutrition KW - Prealbumin KW - Protein-energy wasting SP - 107 EP - 117 JF - Clinical nutrition (Edinburgh, Scotland) JO - Clin Nutr VL - 36 IS - 1 N2 - 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 = 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 increase in mean serum prealbumin, a surrogate marker for outcome and survival in hemodialysis patients suffering from PEW, and is superior to nutritional counseling. Clinical trial registry:www.clinicaltrials.gov (NCT00501956). SN - 1532-1983 UR - https://www.unboundmedicine.com/medline/citation/26708726/Intradialytic_parenteral_nutrition_in_maintenance_hemodialysis_patients_suffering_from_protein_energy_wasting__Results_of_a_multicenter_open_prospective_randomized_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0261-5614(15)00336-2 DB - PRIME DP - Unbound Medicine ER -