Artificial Nutritional Support in Chronic Hemodialysis Patients: A Narrative Review

Article Outline

• Abstract
• Methods
  • Oral Nutritional Supplements
  • Intradialytic Parenteral Nutrition
• Conclusion
• References
• Copyright

Objective

Malnutrition is common in hemodialysis (HD) patients and is a powerful predictor of morbidity and mortality. While much progress has been made in identifying the causes and pathogenesis of malnutrition in patients on HD, no consensus has been reached on its management. Nutritional counseling, appetite stimulants, growth hormone, androgenic anabolic steroids, and anti-inflammatory drugs have been tested with contradictory and nonconclusive results. Oral nutritional supplements (ONSs) and intradialytic parenteral nutrition (IDPN) also have been studied.

Design/Setting/Patients

We searched the MEDLINE and PubMed databases for randomized clinical trials, comparative nonrandomized clinical trials, studies with patients who were controls for themselves, and single-arm studies on ONS and IDPN. Thirty-four studies (3223 patients) have been identified and analyzed. Seventeen studies were on ONS (778 patients) and 17 were on IDPN (2475 patients).

Results

ONS may improve serum albumin levels and/or other nutritional parameters, whereas there are insufficient data on clinical outcome. IDPN improves serum albumin and body weight.

Conclusion

Data on survival are conflicting but the only study with an adequate population sample shows that IDPN does not influence survival. Randomized, controlled studies are needed to clarify the role of ONS and IDPN in the treatment of malnutrition in HD.

MALNUTRITION is common in end-stage renal disease (ESRD) patients on maintenance hemodialysis (HD) with prevalence in predialysis ranging from 20% to 80%.¹, ², ³, ⁴ After initiation of dialysis, the nutritional status tends to improve significantly.⁴, ⁵ However, malnutrition remains common among patients receiving dialysis, with the prevalence varying between 23% and 73%.¹, ², ³, ⁴, ⁵

The pathogenesis of malnutrition in patients on HD is multifactorial and secondary essentially to predialysis restrictive diets, inadequate nutritional intake due to anorexia, gastropathy and enteropathy, inflammation and/or infection, medications, psychosocial factors (depression, poverty, alcohol/drugs abuse), dialysis-related factors (inadequate Kt/V, postdialysis fatigue, cardiovascular instability), dialysis-related nutrient losses, alterations in protein metabolism, metabolic acidosis, and inflammation.¹, ², ³, ⁴, ⁵

Malnutrition increases morbidity and mortality and significantly affects quality of life. In recent years, much progress has been made in identifying the causes and the pathogenesis of malnutrition in patients on HD as well as in recognizing the link among malnutrition, inflammation, and mortality.⁶ However, malnutrition remains a frustrating condition for the clinicians, with the therapeutic armamentarium being poor and not extensively applied in the clinical practice. Along with conventional interventions such as nutritional counseling, novel preventive and therapeutic strategies have been tested, such as appetite stimulants, growth hormone, androgenic anabolic steroids, and anti-inflammatory drugs with contradictory and nonconclusive results.⁶ Oral nutritional supplements (ONS) and intradialytic parenteral nutrition (IDPN) also have been studied as a strategy to prevent and/or treat malnutrition in chronic patients on HD.⁶ The aim of the present review is to evaluate the safety and efficacy of ONS and IDPN in preventing and treating malnutrition in chronic patients on HD.

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Methods 

We searched the MEDLINE and PubMed databases (from January 1990 through July 2009) for randomized clinical trials (RCT), comparative non-randomized studies (CNRS) and studies with patients who were controls for themselves (CS) of ONS, IDPN, and enteral nutrition. We searched the MEDLINE and PubMed using combinations of the following keywords: hemodialysis and oral nutritional supplements, hemodialysis and ONS, hemodialysis and oral dietary supplements, hemodialysis and nutrient supplementation, intradialytic parenteral nutrition, IDPN, hemodiaysis and energy-protein supplementation, and hemodialysis and oral protein supplements. We included only human studies. We also examined the reference lists of articles identified by this search strategy and selected those we judged relevant according to the above criteria. Finally, we searched MEDLINE using the acronyms or full titles of the major trials and cohort studies to identify additional publications (Fig. 1).

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• Figure 1 

  Flow diagram showing how studies were accumulated from PubMed and MEDLINE search.

Overall, 34 studies with a total of 3223 patients have been identified and analyzed. Seventeen studies were on ONS (778 patients) and 17 were on IDPN (2475 patients).

Oral Nutritional Supplements 

ONS specific for HD patients have been designed to provide adequate energy, protein, vitamins and minerals, and limited amounts of potassium, phosphate, and fluids. They are available as energy or protein sources or a combination of both. Supplements are in the form of solid food, powders, or liquid formulations.

Overall, four RCT have been conducted (Table 1). Some of these studies included less than 10 or 20 subjects with the probability that the risk factor balance across exposure arms being quite low, thereby negating much of the value of randomization.

Table 1. Effects of Oral Nutritional Supplements in Patients on Dialysis: Randomized, Controlled Trials

HD, hemodialysis patients.

More than 10 years ago, Kuhlmann et al.⁷ randomized 8 malnourished patients to receive, in addition to usual diet, ONS to increase intake by 25% or by 10% for 3 months. In the first group, a significant increase of serum albumin was observed. Cockram et al.⁸ compared the safety and tolerance of three medical nutritional products when used as sole sources of nutrition in 79 stable normally nourished patients on HD. During the first week of the study, baseline medical history and physical examination, gastrointestinal symptom, urea kinetic, bowel habit, and biochemical data were collected while participants ingested their usual diet. During the last 2 weeks, the same data were collected while participants orally ingested 35 kcal/kg actual weight/d of one of three medical nutritional products (one standard formula and two different disease-specific formulae). All three groups achieved a mean energy and protein intake of approximately 35 kcal/kg/d and 1.25 g protein/kg/d during the last 10 days of the sole source feeding period. By intention-to-treat analysis, there were no changes in number or severity of gastrointestinal symptoms, stool frequency or stool consistency, or urea kinetics between the baseline week and during product consumption. In comparison to the standard product, the disease-specific formulations resulted in improved serum phosphorus and calcium-phosphorus product. In the study of Sharma et al.,⁹ nondiabetic adult patients on HD with a body mass index <20 and a serum albumin <4.0 g/dL were randomized into a control group, who received appropriate monitoring including dietary recall and counseling for the prescribed diet (protein intake of 1.2 g/kg/d and energy intake of 35 to 40 kcal/kg/d), and two treatment groups who in addition received a post-HD nutritional supplement providing 500 kcal and 15 g of protein (one homemade and one disease specific) for 30 days. All groups showed an improvement in dry weight and body mass index, whereas in the supplemented groups, a significant increase in serum albumin levels and functional scoring on a 10-point Karnoksky scale (from 8.0 to 8.4 versus 8.1 to 8.0) was documented. Fouque et al.¹⁰ assigned 86 patients on HD to standard care or to ONS for 3 months. Intention-totreat analysis did not show statistically significant changes in dietary intakes as well as in serum albumin and prealbumin levels between groups. However, the supplemented group exhibited an improvement of Subjective Global Assessment score and quality of life.

As shown in Table 2, NCRS and CS also have been conducted to explore the role of ONS in HD-related malnutrition. Cuppari et al. studied 10 patients on HD before and after 3 months of ONS and showed a significant increase in weight (+1.5 kg; 3%) and fat mass but not in muscle mass.¹¹ Beutler et al.¹² assigned to nutrition supplement and counseling or only to nutrition counseling 11 chronic HD patients for 4 months. Serum albumin levels improved significantly from 3.2 ± 0.8 to 3.32 ± 0.8 mg/dL in the supplemented group and remained unchanged in the comparative group. Shah et al.¹³ compared 44 patients on HD who received usual diet with 44 patients on HD who were given usual diet and a nutritional supplement (Nepro; 1 can each day of dialysis for 3 months). There was no significant difference in change in Kidney Disease Quality of Life Questionnaire scores between the two groups, although the physical domain increased significantly in the intervention group. In the study of Patel et al.,¹⁴ 17 patients on HD with both a low protein catabolic rate and a dietary protein intake lower than 1.2 g/kg body weight/d received dietary supplements for 2 month. With respect to baseline, an increase of the protein catabolic rate and the total protein intake was observed at month 2 and at 6 months following intervention. Conversely, no significant changes of nutritional status were observed. Wilson et al.¹⁵ demonstrated that nutritional repletion occurred more quickly and was maintained for a longer period of time in patients on HD with mild hypoalbuminemia who received the diet counseling associated with oral supplementation, with respect to patients who received the diet counseling only.

Table 2. Effects of Oral Nutritional Supplements in Patients on Hemodialysis: Nonrandomised Controlled Trials and Cross-over Trials

Caglar et al.¹⁶ followed 85 patients on HD for a 3-month baseline period during which they received conventional nutritional counseling. Then, patients were given ONS specifically formulated for HD, over a period of 6 month. Unfortunately, 17 patients (20%) refused to ingest the oral supplementation and 10 (11.7%) showed decreased compliance ingesting less than 75% of prescribed nutritional supplementation. At the end of the study, in the 39 patients who completed the study, a significant increase was observed in serum albumin (from 3.33 ± 0.32 to 3.65 ± 0.26 g/dL) and prealbumin (from 26.1 ± 8.6 to 30.7 ± 7.4 mg/dL) levels and in the SGA score. Steiber et al.¹⁷ screened 117 patients on HD by use of the HD-PNI (Hemodialysis Prognostic Nutrition Index, which is calculated from baseline data as a linear mathematical equation using the level of serum albumin, level of serum creatinine, and number of days and times hospitalized). Then, they administered ONS for 3 months to 26 patients at high risk (HD-PNI 0.8 or higher) while maintaining the normal nutritional regimen in 91 patients at low risk (HD-PNI less than 0.8). In the ONS group, the HD-PNI score was reduced significantly (from 1.92 ± 1.16 to 1.42 ± 1.59; P < .05) while it remained unchanged in the patients who received the normal nutritional regimen.

In the prospective, comparative study of Scott et al.,¹⁸ 88 patients on HD received standard care or ONS (with each HD session thrice weekly for 3 months). Mean serum albumin levels remained essentially unchanged between baseline and month 3 both in the ONS group (3.68 ± 0.33 versus 3.75 ± 0.4) and in the standard care group (3.93 ± 0.34 versus 3.81 ± 0.37).

In addition to habitual diets, Ewers et al.¹⁹ administered oral unsaturated fat supplements (430 kcal, 47 g of fat, 26.5 g of monounsaturated fatty acids) and 3 g of marine n-3 polyunsaturated fatty acids daily for 6 weeks to 40 chronic patients on HD. Then, the patients were switched to habitual diet only, for an additional 6 weeks. In the 14 patients who completed the study, a significant increase in body weight and decrease in C-reactive protein levels were observed. The study of Acchiardo et al.²⁰ only assessed the effect of ONS on survival in patients on HD. The study included 108 patients on HD who were divided into two groups—a control group of 54 patients who did not receive ONS and a treatment group of 54 patients who received ONS for a unknown period of time. The annual mortality rates were similar in the two groups. However, patients who received ONS and survived 5 years had a significant increase in their protein catabolic rate (from 0.84 ± 0.2 to 0.98 ± 0.2) and serum albumin levels (3.49 ± 0.4 to 3.87 ± 0.3).

Some studies have evaluated the safety and efficacy of oral amino acids supplements (Table 3). Apart from early studies that were nonrandomized and included a small number of patients, two recent trials led to interesting results. Eustace et al.²² demonstrated that oral amino acid supplements in hypoalbuminemic patients on HD resulted in a significant improvement in serum albumin levels, grip strength, and Short Form Health Survey (SF-12) mental health score but not in serum amino acid levels, SF-12 physical health score, or anthropometric measures. Hiroshige et al.²³ randomized 28 malnourished patients to receive daily branched chain amino acid supplementation (BCAA) (12 g/day) or placebo. After 6 months, anthropometric indices and serum albumin levels showed a statistically significant increase in the BCAA group. After exchanging BCAA for placebo, spontaneous oral food intake decreased, although the favorable nutritional status persisted for the next 6 months, suggesting that the normalization of plasma BCAA levels can reduce anorexia and improve energy and protein intakes in patients on HD.

Table 3. Effects of Oral Protein Supplements in Patients on Hemodialysis: Nonrandomised, Controlled Trials and Cross-over Trials

BCCAA, branched chain amino acids; EAA, essential amino acids; HD, hemodialysis; NEAA, nonessential amino acids; PD, peritoneal.

Overall, it seems that ONS may improve serum albumin levels and/or other nutritional parameters in patients on HD, whereas there are insufficient data to assess their effect on clinical outcome. In addition, poor compliance may be a key limiting factor for ONS efficacy.

Intradialytic Parenteral Nutrition 

IDPN has the advantage of providing calories and proteins during HD treatment without the need to establish a central venous line. The nutrients are infused into the blood returning from the dialyzer to the patient.

The effect of IDPN on protein metabolism of HD patients has been extensively studied by Pupim et al. in two recent prospective, randomized studies²⁴, ²⁵, ²⁶ (Table 4). In the first trial, 7 patients were studied 2 hours before, during, and 2 hours following an HD session with or without IDPN, using a primed constant infusion of l-(1-¹³C)leucine and l-(ring-²H₅) phenylalanine. As result, IDPN promoted a large increase in whole-body protein synthesis and a significant decrease in whole-body proteolysis, along with a significant increase in forearm muscle protein synthesis. The net result was a change from an essentially catabolic state to a highly positive protein balance, in both whole-body and forearm muscle compartments.²⁴ More recently, the same authors, measuring the plasma enrichments of (¹³C)leucine and (¹³C)ketoisocaproate after infusion of (¹³C)leucine, showed that IDPN improves the fractional synthetic rate of albumin during HD in parallel with a significant improvements in whole-body protein synthesis.²⁵ Interestingly, Pupim et al.²⁶ also demonstrated that exercise combined with IDPN, compared to IDPN alone, promoted two-fold increases in forearm muscle essential amino acid uptake and net muscle protein accretion during HD. An interesting finding of the studies of Pupim et al. was that the observed anabolic effects of IDPN were rapidly reversed during the postdialysis period when the IDPN was no longer being infused. These results imply that IDPN provides only a transient improvement in uremia and HD-associated catabolism and cannot effectively correct these prolonged catabolic effects.

Table 4. Effects of Intradialytic Parenteral Nutrition (IDPN) on Protein Metabolism

Studies that examined the potential benefits of IDPN in terms of correction of malnutrition (Table 5) are characterized by various and numerous biases: absence of randomized control groups, dietary intake of food not controlled or monitored, size of the study population too small for a valid statistical analysis, data not adjusted for the comorbid conditions of the patients, measurement only of nutritional outcomes with morbidity and mortality rarely evaluated, and energy and protein intakes often inappropriate.²⁷, ²⁸, ²⁹, ³⁰, ³¹, ³², ³³, ³⁴, ³⁵, ³⁶, ³⁷ Overall, the results of most of these studies show that IDPN is associated with an increase in body weight and/or improvement of nutritional parameters.

Table 5. Effects of Intradialytic Parenteral Nutrition (IDPN) on Nutritional Status in Hemodialysis Patients

Four studies only assessed the effect of IDPN on survival (Table 6). Three retrospective trials showed that IDPN increases survival.³⁸, ³⁹, ⁴⁰ In the study of Foulks et al.,³⁸ 45 of 72 hypoalbuminemic patients on HD who received IDPN for 6 months experienced an increase of body weight of at least 10% and showed a significant reduction of hospitalization rate and increase of survival. Capelli et al.³⁹ compared the mortality rate in a group of 50 patients who received IDPN and in a group of 31 patients who did not. Nondiabetic patients received an average of 725 kcal/HD treatment and diabetic patients received an average of 670 kcal/HD treatment. The average length of treatment was 9 months. Overall, there was no statistically significant difference in the percentage of deaths between IDPN-treated (36%) and untreated (48%; P = .27) groups. Similarly, no difference was observed in the percentage of deaths between IDPN-treated and untreated patients in diabetic (50% versus 54; P = .83) and in nondiabetic (26% versus 44%; P = .21) groups. Using the Cox proportional hazards survival analysis, a significantly increased survival was observed with the use of IDPN (relative risk = 1.34; P < .01). In the study of Chertow et al.,⁴⁰ 1679 patients on HD who received one or more infusions of IDPN during 1991 were retrospectively compared with 22,517 unexposed controls. At lower levels of albumin (3.0 g/dL or less) and creatinine levels greater than 8.0 mg/dL, the odds of death was 3.14 (95% CI, 2.26–4.36) in the IDPN group and 4.93 (95% CI, 3.41–7.12) in the control group, resulting in a odds ratio of 0.64 (95% CI, 0.44–0.92; P < .01). With serum albumin of 3.0 g/dL or less and creatinine levels less than 8.0 mg/dL, the odds of death was 5.45 (95% CI, 3.96–7.50) in the IDPN group and 8.62 (95% CI, 5.95 and 12.49) in the control group, resulting in and odds ratio of 0.63 (p<0.01). With serum albumin levels >3.0 and <3.5 g/dL, the odds of death of patients who received IDPN compared with that of controls. In contrast, in patients with serum albumin levels greater than 4.0 g/dL, IDPN with respect to controls was associated with increased mortality (odds ratio: 2.60 [CI, 1.34–5.04]). More recently, a larger, randomized study⁴¹ showed that IDPN associated with ONS (93 patients), compared with ONS alone (93 patients), did not improve 2-year mortality, hospitalization rate, Karnofsky score, BMI, or laboratory nutritional parameters. However, multivariate analysis showed that an increase in prealbumin levels (greater than 30 mg/L within 3 months) independently predicted a 54% decrease in 2-year mortality as well as reduced hospitalizations and improved general well-being as measured by the Karnofsky score. As suggested by the authors of the study, these negative results question the study power. Indeed, the power was calculated to be 78% and a tentative estimation of sample size using the 1-year efficacy observed in the study showed that a minimum of 1364 patients in each group would have been necessary to potentially observe a difference with a power of 80%. Interestingly, a study conducted in 1993, including patients who met the Medicare eligibility requirements for IDPN, demonstrated that although IDPN improved serum albumin levels significantly, no significant improvement in quality of life could be demonstrated.⁴²

Table 6. Effects of Intradialytic Parenteral Nutrition (IDPN) on Survival in Hemodialysis Patients

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Conclusion 

Malnutrition is a major issue in the long-term management of ESRD patients on maintenance dialysis, adversely affecting morbidity, mortality, functional activity, and quality of life. Its multifactorial pathogenesis implies a multidisciplinary effort including nutritional, metabolic, and pharmacological interventions. If food intake is reduced because of anorexia, BCAA supplements (12 g/daily) may be safely used, without bearing the risk of adverse effects or poor adherence to treatment. Chronic use of oral nutritional supplements is safe and may be useful in terms of improvement of nutritional parameters such as serum albumin and body weight. However, it remains to be clarified if the use of ONS is associated with increased survival. IDPN seems to improve nutritional parameters such as serum albumin and body weight. Data on survival are conflicting and it useful to underline that the sole prospective, randomized, controlled study so far conducted has shown that IDPN does not influence long-term survival. However, when other nutritional therapeutic strategies are unavailable, IDPN may be potentially useful. But this must be assessed through randomized, controlled studies. In conclusion, it seems that further, adequate studies are needed to more accurately clarify the role of both ONS and IDPN in the prevention and treatment of malnutrition in chronic patients on HD.

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