Journal of Renal Nutrition
Volume 14, Issue 2 , Pages 82-88, April 2004

Intradialytic amino acids supplementation in hemodialysis patients with malnutrition: results of a multicenter cohort study☆

Part of this report was presented in abstract form at the World Congress of Nephrology in Berlin, June, 2003.

  • Stanisław Czekalski, MD, PhD

      Affiliations

    • Corresponding Author InformationAddress reprint requests to Stanisław Czekalski, MD, PhD, Department of Nephrology, Transplantology and Internal Diseases, Prof. Stanisław Czekalski ul. Przybyszewskiego 49, 60-355 Poznań, Poland
    • Professor of Medicine, Head of Chair and Department of Nephrology, Transplantology and Internal Diseases, University of Medical Sciences, Poznań, Poland
    • ,
  • Roman Hożejowski, MD

      Affiliations

    • Medical Manager, Medical Department, Fresenius Kabi Poland, Warsaw, Poland
    • ,
  • Malnutrition Working Group

Article Outline

Abstract 

Objective

Prospective evaluation of the effect of 6-month-long intradialytic amino acids (AA) supplementation on selected nutritional variables in malnourished hemodialysis (HD) patients.

Design

Multicenter, prospective, (nonrandomized, noncontrolled) observational study.

Setting

Thirty-one HD units affiliated with academic centers and tertiary-care hospitals.

Patients

Adult patients treated by HD for at least 6 months. Inclusion criteria were: serum albumin concentration ≤39 g/L and at least 4% loss of body weight during the last 6 months in otherwise stable HD patients. From a cohort of 133 patients who were enrolled, 97 (54 men and 43 women) were eligible for the analysis.

Intervention

Intradialytic AA supplementation with 500 mL 10% solution per HD session for a period of 6 months.

Main outcome measures

Serum albumin concentration, modified Subjective Global Assessment (SGA) score, body mass index (BMI), mid-arm circumference (MAC), and total lymphocyte count. Measurements were recorded at baseline and after 3 and 6 months of AA supplementation.

Results

Serum albumin concentration increased significantly from the mean 32.5 ± 4.6g/L at baseline to 36.4 ± 4.8 g/L at 3 months (P < .001) and 37.1 ± 4.8g/L at final observation (P < .001 versus baseline). Significant correlation was observed between frequency of AA supplementation and serum albumin increase (r = 0.41; P < .0001). Rate of improvement negatively correlated significantly with baseline concentration of serum albumin (r = − 0.42; P < .0001). SGA score significantly improved from median of 16 points at baseline to 12 points at 3 months (P < .01) and 11 points at 6 months (P < .01 versus baseline), and this improvement also correlated with the frequency of AA supplementation. Small yet significant increase of MAC was observed at 6 months (from baseline 24.1 ± 4.3 to 24.8 ± 4.8 cm; P < .01), whereas BMI remained unchanged.

Conclusion

Intradialytic AA supplementation improves selected nutritional parameters of HD patients with malnutrition. The improvement depends on the intensity of supplementation.

 

PROTEIN-CALORIE or protein-energy malnutrition has been reported as a common complication in patients on maintenance hemodialysis (HD) therapy. In various studies, signs of malnutrition have been observed in 10% to 75% of HD patients.1, 2, 3, 4, 5, 6, 7 Several factors act simultaneously in the development of malnutrition in patients with chronic renal failure, including inadequate intake of protein and energy, disturbances in protein and energy metabolism, hormonal derangements, uremic toxicity, infections, superimposed illnesses, and many others, reviewed in detail in earlier publications.8, 9, 10 HD therapy can partly correct some of these factors, but the HD procedure itself is catabolic,11, 12, 13 and, in addition, the average loss of free amino acids (AA) in the dialysis fluid has been reported to be 5 to 8 g/dialysis session,14, 15 and the total losses of AA were estimated as about 10 to 13 g/HD.8 In patients with poor protein intake, HD therapy may become a significant factor in the development of malnutrition.8 It was shown that malnutrition and low serum albumin concentration are associated with increased morbidity and morality in HD patients.16, 17, 18, 19 Therefore, the management of maintenance dialysis patients should be designed to prevent or correct malnutrition, including dietary counseling, maintenance of adequate dose of dialysis, avoidance of acidemia, aggressive medical therapy, and nutritional support during acute catabolic illnesses.20 If, despite these maneuvers, HD patients develop evidence of protein-energy malnutrition, the specialized procedures for nutritional support may be used.20 Intradialytic AA supplementation was introduced as one of the methods of treatment in HD patients with malnutrition. Recently, the favorable effects of this method applied during 3 or 4 months in small groups of the malnourished HD patients have been reported.21, 22 It also was shown that short-term intradialytic parenteral nutrition (IDPN) treatment may serve as a safe and effective nutritional intervention in malnourished children on HD23; however, the results of IDPN treatment still are nonconclusive, as indicated in the review of an evidence-based evaluation of IDPN.24 The goal of this study was to evaluate the effect of 6-month-long intradialytic AA supplementation on selected nutritional variables in the malnourished HD patients.

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Patients and methods 

By February, 2003, 133 adult patients from 31 dialysis centers in Poland, receiving maintenance HD for at least 6 months and with clinical signs of protein-calorie malnutrition, were qualified by the treating physicians for intradialytic AA supplementation and were included in this prospective, observational study. The criteria for inclusion in the study were serum albumin concentration ≤39 g/L and at least 4% loss of body weight during the last 6 months. The vast majority of the patients remained on thrice weekly bicarbonate HD. The duration of dialysis procedure averaged 12 hours per week.

Exclusion criteria were documented malignancies, acute infectious diseases within the last 2 months, decompensated heart failure, congenital abnormalities of AA metabolism, and life expectancy of less than 3 months. AA supplementation was provided with intradialytic administration of 500 mL of 10% solution Nephrotect (Fresenius Kabi, Bad Homburg, Germany), if possible during each HD session for a period of 6 months; yet, the actual number of AA infusions was dependent on the individual decision of the treating physician. The solution contains L-AA and tyrosine dipeptide in relative quantities adjusted to the alterations of AA metabolism of patients with renal insufficiency. The AA composition of the solution is shown in Table 1.

Table 1. Composition of the Infused Amino Acid Solution
L-isoleucine5.80 g/L
L-leucine12.8 g/L
L-lysine monoacetate = 12 g L-lysine16.9 g/L
L-methionine2.00 g/L
L-phenylalanine3.50 g/L
L-threonine3.50 g/L
L-tryptophane3.00 g/L
L-valine8.70 g/L
L-arginine8.20 g/L
L-histidine9.80 g/L
L-alanine6.20 g/L
N-acetyl-L-cysteine = 0.40 g L-cysteine0.54 g/L
Glycine5.31 g/L
L-proline3.00 g/L
L-serine7.60 g/L
L-tyrosine0.60 g/L
N-glycyl-L-tyrosine = 2.40 g tyrosine3.16 g/L
Total amino acids100 g/L
Total nitrogen16.3 g/L
Total energy1,600 kJ/L (400 kcal/L)

The impact of treatment on nutritional parameters was assessed by measurements of serum albumin, evaluation of modified SGA score, anthropometric parameters (body weight, body mass index [BMI], MAC), and total lymphocyte count. Blood samples for serum albumin measurements were drawn from the arteriovenous shunt in the morning (between 7 and 10 AM) on the day of midweek HD session. An automated method using the Technicon autoanalyzers was used. On the same day, the modified SGA score was evaluated, and anthropometric parameters were measured in each center by the same trained person after the HD session.

The modified SGA scale is a quantitative scoring system for evaluation of malnutrition in HD patients.24 The total score in this scale lies within the range of 7 to 35 points. A higher score denotes a tendency toward protein-calorie malnutrition. Serum concentration of creatinine and urea also were documented in each patient. All recorded parameters were measured at baseline and after 3 months and 6 months of AA supplementation.

At the deadline of data collection for this analysis, 107 patients in 31 dialysis centers completed the whole 6-month period of intradialytic AA supplementation. Five patients were withdrawn because of side effects. These included loose stools/diarrhea in 2 cases, and pruritus, malaise, and retrosternal pain, each in 1 subject. Nine patients were lost to follow-up because of other reasons, such as renal transplantation or change of domicile. Twelve patients died before completing treatment. The reasons for deaths were: cerebral infarct (2 cases), acute respiratory failure in the course of pneumonia (2 cases), myocardial infarction (1 case), sepsis (1 case), mechanical ileus (1 case). In 5 subjects, the reason for death was not known to the investigators. To avoid bias of study results by administration of human albumins during the observation period in 10 subjects, the data of those patients were excluded from the analysis. Hence, the analyzed group consists of 97 patients (54 men and 43 women). Baseline characteristics of the group are shown in Table 2.

Table 2. Baseline Characteristics of Patients
Female (n = 43)Male (n = 54)Total (n = 97)
Age (y)
Mean ± SD57.3 ± 14.256.2 ± 15.456.7 ± 14.8
Range30.1–78.322.0–82.422.0–82.4
Weight (kg)
Mean ± SD56.3 ± 10.463.1 ± 10.160.1 ± 10.7
Range37.0–80.239.0–83.437.0–83.4
Body mass index
Mean ± SD21.5 ± 3.321.2 ± 2.921.4 ± 3.0
Range14.8–28.516.4–28.014.8–28.5
Mid-arm circumference (cm)
Mean ± SD23.7 ± 5.424.4 ± 3.124.1 ± 4.3
Range17.0–48.519.0–35.017.0–48.5
Serum albumin (g/L)
Mean ± SD32.4 ± 4.732.6 ± 4.632.5 ± 4.6
Range17.4–39.019.0–39.017.4–39.0
Total lymphocyte count (109/L)
Mean ± SD1.76 ± 0.841.57 ± 1.121.65 ± 1.00
Range0.23–4.210.44–7.740.23–7.74
Modified Subjective Global Assessment score
Median151616
Range10–318–328–32

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Statistical methods 

Statistical analysis was performed with the GraphPad Prism version 3.03 software package (GraphPad Software, San Diego, CA). In case of normal distribution, means at consecutive critical points were compared using one-way repeated measures analysis of variance (ANOVA). Subsequently, post-hoc tests (Bonferroni) were computed if the overall P value was less than .05. In case of nonnormal distribution, the Kruskal-Wallis test was used with subsequent Dunn’s multiple comparison posttests. Correlation between frequency of AA supplementation and changes of nutritional variables was assessed by Pearson correlation r or the Spearman rank correlation coefficient. Significance was defined as P < .05. All analyses were 2-tailed. If not otherwise indicated, all values cited in this report denote mean ± standard deviation (SD). Because of nonnormal distribution of Subjective Global Assessment (SGA) score, this variable was presented using medians and ranges.

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Results 

Serum albumin concentration 

Mean serum albumin concentration changed significantly within the observation period (P < .0001). After 3 months of AA supplementation, the parameter increased significantly from a baseline value of 32.5 ± 4.6 g/L to 36.4 ± 4.8 g/L (P < .001). The improvement was maintained at final observation (ie, at month 6) (37.1 ± 4.8 g/L; P < .001 versus baseline). The rate of improvement correlated significantly and negatively with the baseline value of serum albumin concentration (Fig 1) (r = −0.42; P < .0001) and was greater in patients with baseline albumin <34g/L (n = 55) compared with subjects with albumin ≥34g/L (n = 42). In the former subgroup, mean observed increase was 4.9 g/L after 3 months and 6.0 g/L after 6 months, whereas in the latter subgroup serum albumin concentration improved by 2.6 g/L and 2.8 g/L, respectively. Changes of serum albumin concentration within the study period are shown in Fig 2.

  • View full-size image.
  • Figure 1. 

    Correlation between baseline serum albumin concentration (SAlb) and serum albumin increase at month 3. Dashed lines demarcate 95% CI of the linear regression line.

All patients were supposed to have AA administered at each HD session. The patients remained on a thrice-weekly schedule of HD; thus, the target number of AA applications was 72 per patient during the study period; however, the actual rate of sessions with AA supplementation varied from 50% to 100% during the first 3 months of treatment and from 14% to 100% during the second study period (3 to 6 months). This allowed the investigators to analyze the correlation between intensity of AA supplementation and changes of recorded variables. As shown in Fig 3, change of serum albumin concentration correlated significantly with number of intradialytic AA applications during 3 months of treatment (r = 0.41 P < .0001) and, less significantly, at 6 months of treatment (results not shown).

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  • Figure 3. 

    Correlation between number of AA applications and serum albumin increase (interval 0 to 3 months). Dashed lines demarcate 95% CI of the linear regression line.

SGA score 

The SGA score changed significantly during the study (P < .0001). After 3 months of AA supplementation, the total score changed significantly (P < .01) from a baseline median value of 16 points (range, 8 to 32) to 12 points (range, 7 to 23). The achieved improvement of SGA also was maintained at final observation with a median score of 11 points (range, 7 to 21) (P < .01 versus baseline). The SGA score correlated significantly with the serum albumin level at all measurements (baseline: r = −0.38, P = .0001; 3 months: r = −0.27, P = .008; 6 months: r = −0.44, P < .0001). Changes of SGA score within the observation period are shown in Figure 4. A higher frequency of AA supplementation also correlated with better improvement in SGA score at 3 months (r = −0.22; P = .03).

  • View full-size image.
  • Figure 4. 

    Changes of SGA score within observation period. Horizontal lines depict medians, boxes are Q1/4 and Q3/4; vertical symbols show highest and lowest values; ∗P < .001 versus baseline.

Anthropometric measures 

Body weight and BMI remained unchanged during the observation period. However, analysis showed significant changes in MAC. After 6 months of AA supplementation, a small yet significant increase in MAC was observed from the baseline value of 24.1 ± 4.3 cm to 24.8 ± 4.8 cm (P < .01).

Total lymphocyte count 

After 3 months of treatment, a modest increase in total lymphocyte count was observed from the baseline level of 1.66 ± 1.01 × 109/L to 1.79 ± 1.05 × 109/L at 3 months and 1.76 ± 0.87 × 109/L at 6 months. Observed changes of means of lymphocyte count were at the edge of statistical significance (P = .06).

Renal parameters 

There was a minor and insignificant increase in serum creatinine concentration during the observation period. Respective means were 689 ± 188 μmol/L, 706 ± 180 μmol/L, and 706 ± 201 μmol/L.

Also, the means of the serum urea concentration increased only slightly during the study. Mean values at consecutive measurements were 20.9 ± 6.8 mmol/L, 21.9 ± 6.7 mmol/L, and 21.5 ± 7.1 mmol/L

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Discussion 

Correct assessment of nutritional status in HD patients is difficult, because there is not a single test that can be considered an indicator of protein-calorie malnutrition. For this prospective, multicenter study, we decided to apply only simple (but most commonly used) markers of malnutrition: serum albumin concentration ≤39g/L and at least 4% loss of body mass during the last 6 months in otherwise stable HD patients. These rather liberal inclusion criteria resulted in a wide range of nutritional variables measured at the beginning of the study. The exclusion criteria were applied to reduce a possibility of including the patients with malignancies, severe comorbidity, and systemic inflammatory response, which might confound the effect of treatment; however, it was not possible to measure inflammatory markers in all patients.

Our results show that intradialytic AA supplementation in HD patients with malnutrition resulted in a highly significant increase in serum albumin concentration. The increase in serum albumin concentration was greater after 3 months of treatment than after a consecutive 3 months of AA supplementation.

This difference may be attributed partly to less intense intradialytic AA supplementation during the second observation period. The suspected reason was improvement in serum albumin concentration and the diminution of the SGA score reached during the first 3 months of treatment. The demonstrated correlation between the number of AA infusions and the increase of serum albumin concentration during the first 3 months of the observation period supports this possibility, and indicates that the favorable effect of intradialytic AA supplementation on nutritional parameters depends on the intensity of therapy. The greater rate of improvement in serum albumin concentration in patients with baseline levels below 34 g/L also may be attributed to more intense AA supplementation in these patients when compared with those with albumin concentration ≥34g/L, but it suggests, in addition, that the favorable effect of AA supplementation is particularly evident in patients with more pronounced signs of malnutrition. Similar observations were reported by Chertow et al26 in relation to the effect of IDPN in malnourished dialyzed patients. IDPN recipients with albumin less than 34 g/L showed significant increases in albumin and creatinine over time, whereas this was not seen in nontreated patients. Furthermore, dialysis patients with serum albumin less than 34g/L who were treated with IDPN had a significant decrease in the odds ratio for death in 1 year.26 Although the increase of serum albumin concentration in our patients with a baseline value of albumin ≥34g/L was mild (2.6 g/L and 2.8 g/L after 3 and 6 months of AA supplementation, respectively), its potential beneficial effect cannot be neglected. Lowrie and Low19 reported that the risk of death increased with decreasing albumin concentrations in HD patients. Even slightly decreased albumin concentration (between 35 and 39 g/L) was associated with a 2 times greater relative risk of death compared with patients with a serum albumin concentration ≥40g/L.

The mean increase in serum albumin concentration of 3.9 g/L observed in our patients after 3 months of AA supplementation is consistent with the findings of other investigators.21, 22 Navarro et al21 reported 6.0 g/L as the median increase of serum albumin concentration in 10 patients receiving AA supplementation during 3 months (30 intradialytic AA infusions). Oguz et al22 in 14 patients treated with intradialytic AA supplementation during 3 months reported a significant but much smaller mean increase in the serum albumin level of 1.8 g/L. It was shown that AA supplementation by intradialysis, although resulting in higher AA losses into dialysis fluid, can produce a positive net AA balance and prevent a reduction in plasma AA concentrations.21 Most importantly, intradialytic AA supplementation results in a significant increase in serum albumin.

The increase in serum albumin concentration suggests that the intradialytic AA supplementation promotes their effective use for protein synthesis. It was documented that the protein catabolic rate increased significantly in HD patients receiving intravenous AA infusions.21 An increase in dietary nutrients intake was proposed as a potential contributing factor to this increase in protein catabolic rate when, as in our patients, any modification in the dialysis dose was introduced during the treatment period and some increase of serum concentration of creatinine and urea was observed.21 This factor may also favorably influence significant improvement of the SGA score, confirming the effect on other nutritional variables, which correlated with the quantity of AA infusions. Apart from the direct effect of AA supplementation, the improvement of the SGA score also may be attributed partly to an increase in dietary nutrients intake attributable to increased physician attention with improved nutrition counseling. Intradialytic AA supplementation was also associated with a reversal of body mass reduction observed before the initiation of treatment, because no further decline of body weight or change of BMI were recorded during 6 months of treatment. Similar stabilization of body mass or BMI during AA supplementation was observed by other investigators.21, 22 No changes in anthropometric nutritional indices were also reported in malnourished HD patients until after 6 months of IDPN.27, 28 In our study, a small but significant increase in MAC was observed only after 6 months of treatment, additionally documenting the effect of AA supplementation on one of the commonly used anthropometric nutritional parameters.

A small increase in the mean value of the total lymphocyte count that was found after 3 and 6 months of AA supplementation in the patients participating in this study did not reach statistical significance; therefore, the observed tendency toward higher total lymphocyte count should be interpreted with caution, but may suggest a favorable direction, because a lowered total lymphocyte count was identified as the only nutritional parameter predictive of mortality in stable HD patients.29 Nevertheless, it remains to be shown that the amelioration of some nutritional variables observed during intradialytic AA supplementation can improve the morbidity and mortality of the malnourished HD patients.

In conclusion, the results of this study show that intradialytic AA supplementation during 6 months in malnourished HD patients significantly improves selected nutritional parameters. The increase of serum albumin concentration and the improvement of modified SGA correlated with the quantity of AA infusions, which confirms that the beneficial effect of AA supplementation depends on the intensity of treatment.25

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Acknowledgements 

The authors thank the following investigators who collected data for this report:

Bełchatów: Dr. A. Pukaczewska-Woińska; Białystok: Prof. M. Myśliwiec, Dr. T. Hryszko; Ciechanów: Dr. W. Klatko, Dr. T. Wiśniewski; Drezdenko: Dr. B. Lutoborska-Majchrzak; Gdynia: Dr. W. Ślizień, Dr. J. Ṡliwarska-Strońska; Gorzów Wlkp.: Dr. D. Antczak-Jdrzejczak; Kalisz: Dr. W. Ratajewski; Konin: Dr. D. Frankiewicz, Dr. K. Walczak; Koszalin: Dr. O. Mazur; Leszno: Dr. A. Świderski, Dr. Ł. Kasprzak; Lublin: Prof. A. Ksiżek, Dr. A. Bednarek, Dr. I. Baranowicz; Milanówek: Dr. M. Stopiński, Dr. A. Gorczyca; Olsztyn: Dr. A. Całka, Dr. N. Kwella; Płock: Dr. M. ṡwitalski; Poznańn: Doc. I. Pietrzak, Dr. D. Zaremba-Drobnik; Radom: Dr. A. Sokalski; Rybnik: Doc. M. Kuczera; Rzeszów: Dr. W. Bendkowski; Sieradz: Dr. M. Kroczak, Dr. A. Owczarek; Tarnów: Dr. A. Sydor, Dr. L. Czapkowicz-Gryszkiewicz; Toruń: Dr. M. Muszytowski; Wałbrzych: Dr. D. Radziszewska, Dr. P. Miśkiewicz; Warszawa: Prof. R. Gellert; Warszawa: Doc. A. Rydzewski; Włocławek: Dr. J. Ostrowski; Wołomin: Dr. S. Niemczyk, Dr. M. Jastrzbska; Wrocław: Dr. S. Kramarz; Wrocław: Prof. Z. Hruby, Dr. D. Rutkowska; Wrocław: Prof. M. Klinger, Dr. T. Poraoko; Zabrze: Prof. E. Żukowska-Szczechowska, Dr. M. Dwornicki; Zgierz: Dr. J. Wyroślak. The authors also thank Mr. M. Lis for his assistance with statistical analysis.

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☆ Supported in part by a grant from Fresenius Kabi, Poland.

PII: S1051-2276(04)00008-1

doi:10.1053/j.jrn.2004.01.007

Journal of Renal Nutrition
Volume 14, Issue 2 , Pages 82-88, April 2004

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