Objective: To evaluate compliance and the change in serum albumin associated with essential amino acid (EAA) therapy in hypoalbuminemic hemodialysis subjects.
Design and setting: Open label, single intervention, pilot study conducted at 2 outpatient hemodialysis centers located in Baltimore, Maryland.
Subjects: Eighteen patients with a mean 3-month prestudy serum albumin of <3.8 g/dL and a mean Kt/V of > or =1.0, without any recent hospitalizations or infections, who provided informed consent, and who demonstrated > or =90% compliance rate during a 2 week run-in period, were enrolled in the study. The mean age was 61.3 years, 44% were male, 78% were black, and 50% were diabetic.
Intervention: Subjects were instructed to take 3 Aminess N tablets (Recip AB, Stockholm, Sweden) 3 times each day with meals (total of 6.8 g of EAA per day) for 4 months.
Main outcome measure: Median 4-month compliance and the change in mean follow-up serum albumin levels (mean of the serum albumin levels at day 30, day 60, day 90, and day 120 after the start of therapy) compared with mean baseline serum albumin levels (mean of the serum albumin levels at day -90, day -60, day -30, and day 0 before therapy). Secondary outcomes included changes in grip strength and body weight. Data was also collected on C-reactive protein levels, dialysis adequacy (Kt/V), and serum bicarbonate. A 2-day dietary recall was obtained at both the start and finish of the study.
Results: Monthly compliance with EAA tablets remained relatively stable over the study period, with median compliance rates of 86%, 88%, 82%, and 82% at months 1 through 4, and an overall median compliance of 82%. Seventy-eight percent of patients had an overall compliance rate of 70% or greater. Serum albumin improved from baseline to follow-up by a mean (95% confidence interval) of 0.20 g/dL (95% confidence interval, 0.04 to 0.30; P =.001). Lowest postdialysis weight increased from a mean of 74.5 kg to 77.1 kg (P =.05), and there was a nonsignificant increase in grip strength. C-reactive protein levels increased in 33%, remained constant in 11%, and decreased in 56% of subjects, and there was no significant correlation between change in C-reactive protein levels and improvement in serum albumin. Dietary recalls did not show any significant change in the spontaneous protein or caloric intakes in association with the use of the EAA tablets.
Conclusion: Although uncontrolled, these results support the feasibility and benefits of moderate dose oral EAA supplementation in hypoalbuminemic hemodialysis subjects.
Copyright 2001 by the National Kidney Foundation, Inc.