Self-reported appetite, hospitalization and death in haemodialysis patients: findings from the Hemodialysis (HEMO) Study.

BACKGROUND: Anorexia is an important cause of protein-energy malnutrition (PEM) in haemodialysis patients. We investigated whether self-reported appetite was associated with death and hospitalization in subjects enrolled in the Hemodialysis (HEMO) Study. METHODS: The HEMO Study was a 7-year, multicentre, randomized trial (N = 1846), which examined the effects of dialysis dose and membrane flux on mortality and morbidity. Three questions from the Appetite and Diet Assessment Tool (ADAT) were used to determine whether appetite had changed over time in the randomized treatment groups. The relations among ADAT scores, dietary protein and energy intakes, biochemical and anthropometric measures, and quality of life were assessed. We used Cox proportional hazards models to evaluate the relative risks of death and hospitalization associated with static and dynamic ADAT scores, adjusted for demographic factors, dose and flux assignments, and co-morbidity. RESULTS: The average length of follow-up was 2.84 years. After adjusting for demographic factors and randomized treatment assignments, there was a significant association between poorer self-reported appetite and death (RR 1.52, 95% CI 1.16-1.98); however, the association became non-significant with further adjustment for co-morbidity (RR 1.23, 95% CI 0.94-1.62). Poorer appetite was unequivocally associated with increased hospitalization rates (multivariable RR 1.35, 95% CI 1.13-1.61). The longitudinal effect of worsening appetite from baseline to 1 year was not associated with mortality or hospitalization rate after adjusting for co-morbidity. CONCLUSIONS: The association between appetite and death was confounded by co-morbidity. Self-reported appetite was associated with hospitalization rate in haemodialysis patients and, thus, it may be a useful screening tool for this outcome. Patients who report poor or very poor appetites should be monitored, and they should receive more comprehensive nutritional assessments.

Are nutritional status indicators associated with mortality in the Hemodialysis (HEMO) Study?

BACKGROUND: The purpose of this study was to determine if indicators of nutritional status were associated with subsequent mortality in hemodialysis patients. METHODS: Twelve selected nutrition indicators were measured prior to randomization in the Mortality and Morbidity in Hemodialysis (HEMO) Study. Relative risks (RR) of mortality were assessed at <6 months and >6 months of follow-up using Cox regression after controlling for case mix, comorbidity, and treatment assignment (high vs. standard Kt/V and high vs. low membrane flux). RESULTS: Low values of most nutritional status indicators were associated with increased RR of mortality. RRs were greatest over the short term (<6 months) and diminished with increasing follow-up (>6 months). Increases in body mass index (BMI) at lower levels (e.g., < or =25 kg/m(2)) and increases in serum albumin at any level were associated with reduced short-term RR, even after adjusting for case mix, treatment assignment, and for the joint effects of equilibrated normalized protein catabolic rate, total cholesterol, and serum creatinine. For >6 months' follow-up, increases in values among those with lower levels of BMI and serum albumin (< or =3.635 g/dL) and increases in all serum creatinine levels were associated with lower RR. CONCLUSION: Nutrition indicators are associated with subsequent mortality in a time-dependent manner, with greatest effects at <6 months of follow-up. The RR for these indicators may also vary within different ranges of values.

An anti-inflammatory and antioxidant nutritional supplement for hypoalbuminemic hemodialysis patients: a pilot/feasibility study.

BACKGROUND: A low serum albumin concentration < 3.8 g/dL, a marker of malnutrition-inflammation complex syndrome, is observed in approximately half of all maintenance hemodialysis (MHD) patients in the United States and is strongly associated with increased mortality. OBJECTIVES: We hypothesized that a novel oral nutritional intervention with anti-inflammatory and antioxidant properties taken during routine dialysis sessions is well tolerated and corrects hypoalbuminemia in MHD patients. DESIGN: Controlled clinical study. SETTING: An outpatient dialysis facility affiliated with a tertiary care community medical center with six equally distributed hemodialysis shifts and 163 MHD patients. PATIENTS: Among all MHD outpatients of three selected HD shifts (n = 81 patients), 21 subjects had a serum albumin level < 3.8 g/dL. One patient who was hospitalized before the intervention was excluded. The other three dialysis shifts, with 82 MHD outpatients including 20 hypoalbuminemic subjects, were observed as concurrent controls. INTERVENTION: The nutritional intervention included one can of Oxepa and one can of Nepro to be taken together orally during each routine hemodialysis session for 4 weeks. Each can contains 237 mL fluid. Oxepa provides 355 calories and 14.8 g protein per can, includes maltodextrin, medium-chain triglycerides, borage oil, and refined and deodorized fish oil, and is designed for critically ill patients with inflammation and oxidative stress. Each can of Oxepa includes 1,020 mg gamma-linolenic acid, 3,100 mg caprylic acid, 1,080 mg eicosapentaenoic acid, 75 mg taurine, 2,840 IU vitamin A activity, 75 IU vitamin E, and 200 mg vitamin C. Nepro provides 475 calories and 16.7 g protein per can; includes high-oleic safflower oil, corn syrup solids, and fructo-oligosaccharides; and is tailored for the nutritional needs of MHD patients. Oxepa and Nepro also contain L-carnitine, 43 mg and 62 mg, respectively. MAIN OUTCOME MEASURES: Serum albumin pretrial and posttrial. RESULTS: Studied outpatients (12 men and 8 women) were aged 60.4 +/- 13.0 (SD) years. Three patients had started MHD treatment between 1.5 and 3 months before the intervention. Nine patients were diabetic. Preintervention serum albumin, 3.44 +/- 0.34 g/dL (mean +/- SD) increased to 3.68 +/- 0.34 g/dL (P = .001) 4 weeks after the start of the intervention. In 16 patients, serum albumin level increased by 0.2 to 1.3 g/dL, whereas in 4 patients the serum albumin level decreased by 0.2 to 0.6 g/dL. Three patients reported diarrhea, and one diabetic patient had increased serum glucose values. No other side effects were noted. In 20 control outpatients not receiving nutritional intervention, serum albumin did not change from 3.46 +/- 0.20 to 3.47 +/- 10.44 g/dL (P = .47). CONCLUSIONS: In hypoalbuminemic MHD patients, a short-term in-center nutritional intervention with one can of Nepro and one can of Oxepa during HD is practical, convenient, well-tolerated, and associated with a significant increase in serum albumin level. Well-designed randomized placebo-controlled clinical trials are needed to verify the safety and effectiveness of this nutritional intervention and its impact on clinical outcome in hypoalbuminemic MHD patients.

The effect of dialysis dose and membrane flux on nutritional parameters in hemodialysis patients: results of the HEMO Study.

BACKGROUND: The effect of standard or high dialysis dose and low or high dialysis flux on nutritional status was ascertained in 1846 maintenance hemodialysis patients enrolled in the HEMO Study. METHODS: Serum albumin levels, equilibrated protein catabolic rate, and postdialysis weight were obtained monthly, while adjusted protein and energy intake, self-reported appetite assessment, upper arm circumference, and calf circumference were obtained yearly. To account for patient attrition due to death or transfer, three statistical models were used to test the effects of the study interventions on longitudinal changes in nutritional parameters. RESULTS: During the first 3 years of follow-up, neither mean serum albumin levels, which declined by 0.21 g/dL, nor mean postdialysis weight, which declined by 2.7 kg, were significantly affected by either study intervention. Mean levels of all anthropometric measures declined during follow-up. For years 1, 2, and 3, the mean +/- SE declines in upper arm and calf circumferences were 0.35 +/- 0.16 cm (P= 0.031) and 0.31 +/- 0.13 (P= 0.015) cm less, respectively, in the high flux compared to the low flux group. Appetite scores and mean equilibrated protein catabolic rate also declined in all randomized groups; however, the average decline in equilibrated protein catabolic rate during years 1, 2, and 3 was 0.019 +/- 0.007 g/kg/day less in the high dose than the standard dose group (P= 0.007). There was no significant change in either mean energy or protein intake from diet records over time, and neither parameter was affected by the study interventions. CONCLUSION: Although the dose and flux interventions may subtly influence certain nutritional parameters, neither intervention prevented deterioration in nutritional status over time.

Effects of dietary intake, appetite, and eating habits on dialysis and non-dialysis treatment days in hemodialysis patients: cross-sectional results from the HEMO study.

OBJECTIVE: To evaluate differences between dietary energy intake (DEI), dietary protein intake (DPI), appetite, dietary patterns, and eating habits during dialysis treatment days (DD) and non-dialysis treatment days (NDD) in 1,901 adults receiving maintenance hemodialysis who were enrolled in the baseline phase of the National Institutes of Health-sponsored Hemodialysis (HEMO) study. DESIGN: A cross-sectional analysis of participants at baseline (before randomization). SETTING: Fifteen clinical centers across the United States. MEASUREMENTS: DEI, DPI, and self-reported assessment of appetite, dietary patterns, and eating habits. RESULTS: For the entire study cohort, total mean (+/- SD) DEI (1,566 +/- 636 kcal/day) and weight-adjusted DEI (23.2 +/- 9.5 kcal/kg/day) were significantly higher (P <.0001) on NDD than on DD (1,488 +/- 620 kcal/day and 22.2 +/- 9.6 kcal/kg/day), respectively. Similarly, DPI was significantly higher (P <.0001) on NDD (65.0 +/- 29.0 g/day and 0.96 +/- 0.43 g/kg/day) than on DD (60.2 +/- 26.5 g/day and 0.90 +/- 0.41 g/kg/day). On DD and NDD, the mean weight-adjusted DEI for the entire cohort was less than the HEMO study standard of care (SOC) of > or =28 kcal/kg/day, whereas on NDD, several subgroups reported dietary protein intakes that were closer to the study's SOC. These included men, patients under 50 years of age, nonblack participants, those without diabetes, those with a normal or mild Index of Co-Existing Disease score, and those on dialysis for more than 5 years. Protein and energy intakes declined with worsening self-reported appetites in both DD and NDD after adjusting for other subgroup effects. CONCLUSION: Dietary energy and protein intakes of HEMO study participants were lower on DD than on NDD, and also lower than the SOC on both days, particularly with regard to energy intake. People receiving maintenance hemodialysis should be counseled to consume adequate amounts of energy and protein daily, especially on DD. Practitioners should monitor closely those patients who report poor appetite and should intervene appropriately.

Nutritional status assessed from anthropometric measures in the HEMO study.

OBJECTIVE: Anthropometric methods are screening techniques for assessing nutritional stores of fat and lean tissues among persons with renal disease. This report presents cross-sectional baseline data on anthropometric indicators of nutritional status from a group of hemodialysis patients in a multicenter clinical trial, the Hemodialysis (HEMO) Study. DESIGN: The HEMO Study is a prospective, multicenter, randomized, 2 x 2 factorial clinical trial to evaluate the efficacy of the delivered dose of dialysis, defined by Kt/V, and membrane flux in reducing morbidity and mortality in (maintenance) hemodialysis patients. Standardized measures of weight, stature, body mass index (BMI), arm and calf circumference, and triceps and subscapular skinfolds were taken immediately after dialysis. The analytic methods consisted of univariate statistics, including means, standard deviations, and selected percentiles presented as tables of descriptive statistics. Study findings were compared with corresponding national reference data from the Second National Health and Nutrition Examination Survey (NHANES II). PATIENTS: Eligible patients between 18 and 80 years of age on chronic hemodialysis for at least 3 months, receiving hemodialysis 3 times per week and with a residual renal clearance of < 1.5 mL/min were examined. Patients also had to be able to attain an eKt/V of > or = 1.45 in 4.5 hours or an anthropometric volume < 45 to 50 L thus excluding persons with body weights over about 85 kg. The study sample consisted of the first 1,000 randomized patients, 464 men and 536 women; 642 blacks, 318 whites; and 40 of other racial backgrounds out of 1,847 randomized. RESULTS: Differences in nutritional status by sex, race, duration of dialysis, and comorbid disease were found among these patients enrolled in the HEMO Study. In comparison with NHANES II, these hemodialysis patients were, on average, lighter with less adipose and muscle tissue than healthy persons of the same ages. These findings can be indicators of persons with chronic disease. Those with diabetes were overweight based on their BMI values. CONCLUSION: These HEMO Study data provide a clinical reference for the use of these anthropometric indicators in assessing the nutritional status of contemporary hemodialysis patients weighing < 85 kg.

Cross-sectional relationship between dietary protein and energy intake, nutritional status, functional status, and comorbidity in older versus younger hemodialysis patients.

OBJECTIVE: To evaluate the dietary energy intakes (DEI) and dietary protein intakes (DPI) of older (> or = 65 years), middle-aged (50 to 64 years), and younger (< 50 years) maintenance hemodialysis patients enrolled in the Hemodialysis (HEMO) Study, and to describe the relationship between age, nutritional status, functional status, and comorbidity. DESIGN: A cross-sectional analysis of the first 1,397 participants in baseline (before randomization) was performed. MAIN OUTCOME MEASURES: DEI and DPI, serum albumin, creatinine, total cholesterol, normalized protein catabolic rate (nPCR), equilibrated nPCR (enPCR), functional status, and comorbidities. RESULTS: Mean DEI, DPI, serum albumin, creatinine, nPCR, and enPCR were significantly lower in the older compared with the younger patients, despite similar doses of dialysis as measured by equilibrated Kt/V. Mean DEI, DPI, nPCR, and enPCR were not significantly different between the middle-aged and older patients, whereas albumin and creatinine were significantly lower in the older patients. Mean dry weight and percent of standard body weight in the younger and older patients were similar. In all groups, mean DEI was lower than both the HEMO study's standard of care (SOC) and the Kidney Disease Outcomes Quality Initiative (K/DOQI) nutrition recommendations, whereas mean DPI was lower than the SOC and K/DOQI recommendations only in the middle-aged and older patients. Middle-aged and older patients had higher cholesterol, lower functional status, and more comorbidities than the younger patients. CONCLUSION: Middle-aged and older maintenance dialysis patients may be at greater risk for developing protein-energy malnutrition than their younger counterparts. Inadequate DEI and DPI reported in middle-aged and older patients were associated with lower levels of biomarkers of nutritional status, lower functional status, and higher comorbidities than in the younger patients.

Nutritional status in the HEMO Study cohort at baseline. Hemodialysis.

The nutritional status of the first 1,000 patients randomized into the Hemodialysis (HEMO) Study was analyzed at baseline when they received their typical dialysis dose (equilibrated Kt/V = 1.30 +/- 0.22) and dialysis membrane. This is the largest study to date of the nutritional status of chronic hemodialysis patients. The mean (+/- SD) values for these parameters included a serum albumin level of 3.65 +/- 0.38 g/dL, a dietary energy intake of 22.9 +/- 8.4 kcal/kg/day, a dietary protein intake of 0.93 +/- 0.36 g/kg/day, and a double pool normalized protein catabolic rate (enPCR) of 1.00 +/- 0.25 g/kg/day. The percentage of patients below HEMO Study nutritional standards of care included 29% of patients with a serum albumin level less than 3.5 g/dL, 76% of patients with a dietary energy intake less than 28 kcal/kg/day, 61% of patients with a dietary protein intake less than 1.0 g/kg/day, and 52% of patients with an enPCR of less than 1.0 g/kg/day. There was a strong correlation between dietary protein intake and dietary energy intake (r = 0.74, P < 0.0001). Significant correlations were also evident between serum albumin and double pool PCR and between dietary protein intake and double-pool PCR. Kt/V and membrane flux were not predictive of baseline dietary protein intake, dietary energy intake, or serum albumin level. Thus, a majority of patients in the HEMO Study had protein and energy intake levels and enPCR levels that were below National Kidney Foundation Kidney Dialysis Outcome Quality Improvement (NKF-K/DOQI) guidelines.