Effects of Intradialytic Parenteral Nutrition on Blood Glucose in Patients on Maintenance Hemodialysis: A Multicenter, Randomized, Open-Label Study

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Background: The intradialytic parenteral nutrition (IDPN) is reported to improve the nutritional status in the dialysis patients. However, effects of IDPN on the blood glucose (BG) are not enough studied while intra-dialysis unconscious hypoglycemia is the issue if the patients are malnourished. Methods: Study patients were 27 maintenance hemodialysis patients. The investigational (IE) group received the IDPN with ENEFLUID® (550mL; energy, 310kcal; glucose, 37.5g; amino acids, 15g; lipid, 10g) 3 times a week for 12 weeks (wks); control (CT) group did not. The interstitial fluid glucose concentration was monitored every 15 minutes 2 wks after study initiation and before study completion. Outcomes: frequencies and durations of hypoglycemia (BG<70mg/dL) and hyperglycemia (BG>180mg/dL) per 24 hours, area over the curve for glucose<70mg/dL (AOC) per 24 hours, area under the curve for glucose>180mg/dL (AUC) per 24 hours, and Time in Range (BG, 70-180mg/dL). The Mann-Whitney U test was used for the intergroup comparisons. Results: Mean age was 70.6 and mean body mass index was 19.9 for the study patients. Patients used for the statistical analysis were 14 in the IE group and 13 in the CT group; however, 2 of the IE group withdrew and could not receive the BG monitoring 2 wks before study completion. The median [interquartile range (IQR)] frequency of hypoglycemia during dialysis for 2 wks were smaller in the IE group than in the CT group resulting in a significant difference between 2 groups: 2 wks after study initiation, 0.0 (0.0-2.0) in the IE group and 6.9 (0.0-56.7) in the CT group; P=0.01; 2 wks before study completion, 0.0 (0.0-7.6) in the IE group and 12.0 (0.0-30.3) in the CT group; P=0.04. Similar results were obtained for the duration of hypoglycemia and AOC. No intergroup difference was observed for the frequency and duration of hyperglycemia and AUC. The median (IQR) Time in Range during dialysis for 2 wks after the study initiation was 100 (98-100)% in the IE group and 86 (41-99)% in the CT group (P=0.005), showing that higher proportion of the IE group patients achieved the target BG. Conclusion: The IDPN with ENEFLUID® in the maintenance hemodialysis patients may suppress the hypoglycemia while not increasing the hyperglycemia. Funding: Commercial Support - Otsuka Pharmaceutical factory Inc.

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