Hemodialysis Study Research Articles

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

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. 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. 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. 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.

Daily Hemodialysis: The Time Has Come? - Pro

IN RECENT YEARS there has been great interest in studying the effect of dialytic dose on patient outcomes. This interest is based on the concept that a greater dialytic dose results in greater toxin removal, which in turn results in improved patient outcomes. Attempts to increase dose delivery in conventional thrice weekly hemodialysis (HD) by increasing dialysis efficiency with higher blood flow rates and high-flux membranes did not result in improved overall survival in the HEMO Study. 1 Eknoyan G. Beck G.J. Cheung A.K. et al. Hemodialysis (HEMO) Study GroupEffect of dialysis dose and membrane flux in maintenance hemodialysis. N Engl J Med. 2002; 347: 2010-2019 Crossref PubMed Scopus (1559) Google Scholar This clearly indicated that the currently accepted single-treatment target dose was not just that necessary for dialysis adequacy but is also the optimal affordable by such an intermittent therapy. Thus, interest has turned to the possible effect of increasing dialysis frequency; this interest appears to be growing worldwide. Short-duration, high-efficiency (SDHD) and long-duration, slow daily nocturnal hemodialysis (NHD) regimens are the 2 most common forms in use. Occasionally hybrid or combinations of SDHD and NHD are employed. Most reports describe SDHD and NHD as home-based therapies; SDHD has also been used in dialysis centers.

Dose of dialysis: Key lessons from major observational studies and clinical trials

Dose of dialysis: Key lessons from major observational studies and clinical trials

Cardiac diseases in maintenance hemodialysis patients: Results of the HEMO Study

Cardiac disease is a common cause of death in chronic hemodialysis patients. A subanalysis of the data on cardiac diseases in the Hemodialysis (HEMO) Study was performed. The specific objectives were: (1) to analyze the prevalence of cardiac disease at baseline; (2) to characterize the incidence of various types of cardiac events during follow-up; (3) to examine the association of cardiac events during follow-up with baseline cardiac diseases; and (4) to examine the effect of dose and flux interventions on various types of cardiac events. The HEMO Study is a randomized multi-center trial on 1846 chronic hemodialysis patients at 15 clinical centers comprising 72 dialysis units. The scheduled maximum follow-up duration was 0.9 to 6.6 years, with the mean actual follow-up of 2.84 years. The interventions were standard-dose versus high-dose and low-flux versus high-flux hemodialysis in a 2 x 2 factorial design. At baseline, 80% of patients had cardiac diseases, including ischemic heart disease (IHD) (39%), congestive heart failure (40%), arrhythmia (31%), and other heart diseases (63%). There were a total of 1685 cardiac hospitalizations, with angina and acute myocardial infarction accounting for 42.7% of these hospitalizations. There were 343 cardiac deaths during follow-up, accounting for 39.4% of all deaths. IHD was implicated in 61.5% of the cardiac deaths. Any cardiac disease at baseline was highly predictive of cardiac death during follow-up [relative risk (RR) 2.57; 95% CI 1.73-3.83]. There were no significant effects of dose or flux assignments on the primary outcome of all-cause mortality or the main secondary cardiac composite outcome of first cardiac hospitalization or all-cause mortality. Assignment to high-flux dialysis was, however, associated with decreased cardiac mortality and the composite outcome of first cardiac hospitalization or death from cardiac causes. The HEMO Study identified IHD to be a major cause of cardiac hospitalizations and cardiac deaths. Future strategies for the prevention of cardiac diseases in the maintenance hemodialysis population should focus on this entity. Although high-flux dialysis did not reduce all-cause mortality, it might improve cardiac outcomes. This hypothesis needs to be further examined.

High dialysis dose is associated with lower mortality among women but not among men

Background: Several observational studies reported lower mortality risk among hemodialysis patients treated with doses greater than the standard dose. The present study evaluates, with observational data, the secondary randomized Hemodialysis (HEMO) Study finding that greater dialysis dose may benefit women, but not men. Methods: Data from 74,120 US hemodialysis patients starting end-stage renal disease therapy were analyzed. Patients were classified into 1 of 5 categories of hemodialysis dose according to their average urea reduction ratio (URR), and their relative risk (RR) for mortality was evaluated by using Cox proportional hazards models. Similar analyses using equilibrated Kt/V were completed for 10,816 hemodialysis patients in the Dialysis Outcomes and Practice Patterns Study (DOPPS) in 7 countries. Results: For both men and women, RR was substantially lower in the URR 70%-to-75% category compared with the URR 65%-to-70% category. Among women, RR in the URR greater-than-75% category was significantly lower compared with the URR 70%-to-75% group (P < 0.0001); however, no further association with mortality risk was observed for the greater-than-75% category among men (P = 0.22). RR associated with doses greater than the Kidney Disease Outcomes Quality Initiative guidelines (URR ≥ 65%) was significantly different for men compared with women (P < 0.01). Similar differences by sex were observed in DOPPS analyses. Conclusion: The agreement of these observational studies with the HEMO Study supports the existence of a survival benefit from greater dialysis doses for women, but not for men. Responses to greater dialysis dose by sex deserve additional study to explain these differences.

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 × 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 ≥ 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. © 2003 by the National Kidney Foundation, Inc.

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 (≥ 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. © 2002 by the National Kidney Foundation, Inc.

Comorbidity assessment using the Index of Coexistent Diseases in a multicenter clinical trial

The Hemodialysis (HEMO) Study is a multicenter trial designed to determine whether hemodialysis dose and membrane flux affect survival. Comorbid conditions are also important determinants of survival, and thus, an accurate and reliable method to assess comorbidity was required. Comorbidity was being assessed at baseline and annually in the HEMO Study using the Index of Coexistent Disease (ICED). We describe the instrument, its implementation in the HEMO Study, and the results of comorbidity assessment in the first 1000 randomized patients in the trial. The ICED aggregated the presence and severity of 19 medical conditions and 11 physical impairments within two scales: the Index of Disease Severity (IDS) and the Index of Physical Impairment (IPI). The final ICED score was determined by an algorithm combining the peak scores for the IDS and IPI. The range of the ICED was from 0 to 3, reflecting increasing severity. Study personnel at 15 clinical centers were trained to update and abstract data from the dialysis medical records. Availability of data, measures of construct validity, and measures of reliability were adequate; 99.8% and 60.6% of patients had comorbid conditions in at least one IDS or IPI category, respectively. The distribution of patients by ICED level was 0 (0.2%), 1 (34.9%), 2 (31.2%), and 3 (33.7%). In multivariable analysis, the following factors were significantly associated with more severe comorbidity: older age, diabetes and other causes of renal disease, a lower level of education, employment status (unemployed and retired), longer duration of dialysis, and lower serum creatinine. There was a significant variation in the severity of comorbidity among clinical centers after adjustment for other factors. The R2 of the model was 25.3%, indicating that a substantial proportion of the variation in the ICED was not explained by these factors. We conclude that comorbidity assessment using the ICED is feasible in multicenter clinical trials of dialysis patients. There is a large burden of comorbidity in dialysis patients, which is not well explained by the cause of renal disease, demographic, and socioeconomic factors and common clinical and laboratory measurements. These variables should not be considered substitutes for comorbid conditions in case-mix adjustment. Comorbidity assessment is useful to describe the sample population, to improve the precision of the treatment effect, and to use possibly as an outcome measurement.

The role of the dietitian in a multicenter clinical trial of dialysis therapy: The hemodialysis (HEMO) study

The Hemodialysis (HEMO) Study is a randomized multicenter prospective clinical trial, supported by the National Institute of Diabetes, Digestive, and Kidney Diseases of the National Institutes of Health. The trial is designed to assess the effects of a standard versus higher dialysis dose and low versus high dialysis membrane flux on morbidity and mortality of chronic hemodialysis patients. The role of the dietitian in the HEMO Study is to support and maintain the nutritional status of randomized participants. To ensure participant safety, nutritional status is closely monitored by a variety of biochemical and participant-reported parameters. Serum albumin and equilibrated normalized protein catabolic rates are obtained monthly. Appetite assessment and dietary energy and protein intakes using a 2-day diet diary assisted recall are ascertained at baseline and on a yearly basis. Consumption of vitamins, minerals, and nutritional supplements, including oral enterals, tube feedings, and parenteral nutrition, is obtained at least once a year. In addition, anthropometry is performed at baseline and on a yearly basis. Prespecified changes in serum albumin level or body weight trigger action by the dietitian to prevent protein calorie malnutrition. The HEMO Study dietitians play a vital role in carrying out the nutrition program for the trial. The HEMO Study should provide important information about the natural history of the nutritional status of chronic hemodialysis patients and the impact of dialysis dose and dialysis membrane flux on these parameters.

Solutions to challenges encountered in obtaining anthropometric measures among hemodialysis (HD) patients in the hemodialysis (HEMO) study: S. McLeroy, L. Akpele, C. Chumlea, D. Cockram, R.R. Henry, L. Paranandi, D. Poole, L. Uhlin from the HEMO Study, NIDDK, NIH, Bethesda, MD

Solutions to challenges encountered in obtaining anthropometric measures among hemodialysis (HD) patients in the hemodialysis (HEMO) study: S. McLeroy, L. Akpele, C. Chumlea, D. Cockram, R.R. Henry, L. Paranandi, D. Poole, L. Uhlin from the HEMO Study, NIDDK, NIH, Bethesda, MD