The International Society of Renal Nutrition and Metabolism Commentary on the National Kidney Foundation and Academy of Nutrition and Dietetics KDOQI Clinical Practice Guideline for Nutrition in Chronic Kidney Disease.

The Academy of Nutrition and Dietetics and the National Kidney Foundation collaborated to provide an update to the Clinical Practice Guidelines (CPG) for nutrition in chronic kidney disease (CKD). These guidelines provide a valuable update to many aspects of the nutrition care process. They include changes in the recommendations for nutrition screening and assessment, macronutrients, and targets for electrolytes and minerals. The International Society of Renal Nutrition and Metabolism assembled a special review panel of experts and evaluated these recommendations prior to public review. As one of the highlights of the CPG, the recommended dietary protein intake range for patients with diabetic kidney disease is 0.6-0.8 g/kg/day, whereas for CKD patients without diabetes it is 0.55-0.6 g/kg/day. The International Society of Renal Nutrition and Metabolism endorses the CPG with the suggestion that clinicians may consider a more streamlined target of 0.6-0.8 g/kg/day, regardless of CKD etiology, while striving to achieve intakes closer to 0.6 g/kg/day. For implementation of these guidelines, it will be important that all stakeholders work to detect kidney disease early to ensure effective primary and secondary prevention. Once identified, patients should be referred to registered dietitians or the region-specific equivalent, for individualized medical nutrition therapy to slow the progression of CKD. As we turn our attention to the new CPG, we as the renal nutrition community should come together to strengthen the evidence base by standardizing outcomes, increasing collaboration, and funding well-designed observational studies and randomized controlled trials with nutritional and dietary interventions in patients with CKD.

Effects of Oral Nutritional Supplements on Mortality, Missed Dialysis Treatments, and Nutritional Markers in Hemodialysis Patients.

OBJECTIVE: Protein-energy wasting is common in end-stage renal disease patients undergoing dialysis and is strongly associated with mortality and adverse outcomes. Intradialytic oral nutritional supplements (ONS) reduce risk of mortality in these patients. Large studies characterizing the impact of ONS on other outcomes are lacking. We assessed the associations between administration of ONS and clinical and nutritional outcomes. DESIGN: Retrospective evaluation of a pilot program providing ONS to patients at a large dialysis organization in the United States. The pilot program provided ONS to in-center hemodialysis patients with serum albumin ≤3.5 g/dL at 408 facilities. SUBJECTS: ONS patients were compared to matched controls with serum albumin ≤3.5 g/dL, identified from facilities not participating in the ONS program (n = 3,374 per group). INTERVENTION: Receipt of ONS. MAIN OUTCOME MEASURES: Death, missed dialysis treatments, hospitalizations, serum albumin, normalized protein catabolic rate, and postdialysis body weight were abstracted from large dialysis organization electronic medical records. RESULTS: There was a 69% reduction in deaths (hazard ratio = 0.31; 95% confidence interval = 0.25-0.39), and 33% fewer missed dialysis treatments (incidence rate ratio = 0.77; 95% confidence interval = 0.73-0.82) among ONS patients compared to controls (P < .001 for both). The effects of ONS on nutritional indices were mixed: serum albumin was lower, whereas normalized protein catabolic rate values, a surrogate for dietary protein intake, and postdialysis body weights were higher for ONS patients compared to controls during follow-up. CONCLUSIONS: Our evaluation confirmed the beneficial effects of ONS in reducing mortality and improving some indices of nutritional status for hypoalbuminemic hemodialysis patients. We also report the novel finding that ONS can reduce the number of missed dialysis treatments. These results support the use of intradialytic ONS as an effective intervention to improve the outcomes in hemodialysis patients with low serum albumin.

Eating During Hemodialysis Treatment: A Consensus Statement From the International Society of Renal Nutrition and Metabolism.

Poor nutritional status and protein-energy wasting are common among maintenance dialysis patients and associated with unfavorable outcomes. Providing foods, meal trays, snack boxes, and/or oral nutritional supplements during hemodialysis can improve nutritional status and might also reduce inflammation, enhance health-related quality of life, boost patient satisfaction, and improve survival. Potential challenges include postprandial hypotension and other hemodynamic instabilities, aspiration risk, gastrointestinal symptoms, hygiene issues, staff burden, reduced solute removal, and increased costs. Differing in-center nutrition policies exist within organizations and countries around the world. Recent studies have demonstrated clinical benefits and highlight the need to work toward clear guidelines. Meals or supplements during hemodialysis may be an effective strategy to improve nutritional status with limited reports of complications in real-world scenarios. Whereas larger multicenter randomized trials are needed, meals and supplements during hemodialysis should be considered as a part of the standard-of-care practice for patients without contraindications.

Effect of high-protein meals during hemodialysis combined with lanthanum carbonate in hypoalbuminemic dialysis patients: findings from the FrEDI randomized controlled trial.

BACKGROUND: Inadequate protein intake and hypoalbuminemia, indicators of protein-energy wasting, are among the strongest mortality predictors in hemodialysis patients. Hemodialysis patients are frequently counseled on dietary phosphorus restriction, which may inadvertently lead to decreased protein intake. We hypothesized that, in hypoalbuminemic hemodialysis patients, provision of high-protein meals during hemodialysis combined with a potent phosphorus binder increases serum albumin without raising phosphorus levels. METHODS: We conducted a randomized controlled trial in 110 adults undergoing thrice-weekly hemodialysis with serum albumin <4.0 g/dL recruited between July 2010 and October 2011 from eight Southern California dialysis units. Patients were randomly assigned to receive high-protein (50-55 g) meals during dialysis, providing 400-500 mg phosphorus, combined with lanthanum carbonate versus low-protein (<1 g) meals during dialysis, providing <20 mg phosphorus. Prescribed nonlanthanum phosphorus binders were continued over an 8-week period. The primary composite outcome was a rise in serum albumin of ≥0.2 g/dL while maintaining phosphorus between 3.5-<5.5 mg/dL. Secondary outcomes included achievement of the primary outcome's individual endpoints and changes in mineral and bone disease and inflammatory markers. RESULTS: Among 106 participants who satisfied the trial entrance criteria, 27% ( n = 15) and 12% ( n = 6) of patients in the high-protein versus low-protein hemodialysis meal groups, respectively, achieved the primary outcome (intention-to-treat P-value = 0.045). A lower proportion of patients in the high-protein versus low-protein intake groups experienced a meaningful rise in interleukin-6 levels: 9% versus 31%, respectively (P = 0.009). No serious adverse events were observed. CONCLUSION: In hypoalbuminemic hemodialysis patients, high-protein meals during dialysis combined with lanthanum carbonate are safe and increase serum albumin while controlling phosphorus.

Academy of Nutrition and Dietetics and National Kidney Foundation: revised 2014 Standards of Practice and Standards of Professional Performance for registered dietitian nutritionists (competent, proficient, and expert) in nephrology nutrition.

Compelling evidence indicates that the incidence of chronic kidney disease (CKD) is increasing because of an aging population and a higher prevalence of cardiovascular disease, diabetes, and hypertension. Nutrition management of patients with CKD requires early disease recognition, appropriate interpretation of the markers and stages of CKD, and collaboration with other health care practitioners. Better management of CKD can slow its progression, prevent metabolic complications, and reduce cardiovascular related outcomes. Caring for patients with CKD necessitates specialized knowledge and skills to meet the challenges associated with this growing epidemic. The Academy of Nutrition and Dietetics Renal Dietitians Practice Group and the National Kidney Foundation Council on Renal Nutrition, with guidance from the Academy of Nutrition and Dietetics Quality Management Committee, have updated the 2009 Standards of Practice in Nutrition Care and Standards of Professional Performance as a tool for registered dietitian nutritionists working in nephrology nutrition to assess their current skill levels and to identify areas for additional professional development in this practice area. The Standards of Practice apply to the care of patients/clients with kidney disease. The Standards of Professional Performance consist of six domains of professionalism, including: Quality in Practice, Competence and Accountability, Provision of Services, Application of Research, Communication and Application of Knowledge, and Utilization and Management of Resources. Within each standard, specific indicators provide measurable action statements that illustrate how nephrology nutrition principles can be applied to practice. The indicators describe three skill levels (ie, competent, proficient, and expert) for registered dietitian nutritionists working in nephrology nutrition.

Low protein nitrogen appearance as a surrogate of low dietary protein intake is associated with higher all-cause mortality in maintenance hemodialysis patients.

To determine the association between all-cause mortality and dietary protein intake in patients with chronic kidney disease, we performed a large-scale, 8-y prospective cohort study in 98,489 maintenance hemodialysis patients from a multicenter dialysis care provider. Compared with the reference level (60 to <70 g/d), low protein nitrogen appearance (PNA) levels [<30 g/d, HR: 1.40 (95% CI: 1.30, 1.50); 30 to <40 g/d, HR: 1.33 (95% CI: 1.28, 1.39)] was associated with higher all-cause mortality, and high PNA levels [≥110 g/d, HR: 0.92 (95% CI: 0.88, 0.97); 100 to <110 g/d, HR: 0.87 (95% CI: 0.82, 0.91)] were associated with lower all-cause mortality in all analyses. This association was also found in subanalyses performed among racial and hypoalbuminemic groups. Hence, using PNA as a surrogate for protein intake, a low daily dietary protein intake is associated with increased risk of death in all hemodialysis patients. Whether the association between dietary protein intake and survival is causal or a consequence of anorexia secondary to protein-energy-wasting/inflammation or other factors should be explored in interventional trials.

Results of a pilot program to improve phosphorus outcomes in hemodialysis patients.

OBJECTIVE: End-stage renal disease causes dysregulation of bone and mineral metabolism, including increased serum phosphorus levels. Kidney Foundation Kidney Disease Outcome Quality Initiative 2003 guidelines recommend maintaining phosphorus levels between 3.5 and 5.5 mg/dL in dialysis patients. We examined the effects of a focused phosphorus management pilot program designed to improve the percentage of hemodialysis patients achieving phosphorus levels <5.5 mg/dL. DESIGN, SETTING, SUBJECTS, AND INTERVENTION: We conducted a prospective, multicenter, single-arm study at 8 geographically diverse at-risk facilities (n = 702 hemodialysis patients) in a large U.S. dialysis organization. The focused phosphorus management program provided in-service training to staff members, and provided patients with diet and phosphorus management through in-center, 1:1 education and support, direct-to-patient adherence communications, benefit management assistance, and adherence support specific to lanthanum carbonate over a 6-month period. MAIN OUTCOME MEASURE: Facility-level markers of bone and mineral metabolism (phosphorus, parathyroid hormone, corrected calcium) and nutritional status (serum albumin, normalized protein catabolic rate) were assessed before and after program implementation. RESULTS: There was a significant increase in the percentage of patients per facility achieving phosphorus levels <5.5 mg/dL (mean ± SD at baseline = 61.6% ± 5.2%; month 6 = 71.3% ± 9.0%; P < .01) and parathyroid hormone (150 to 300 pg/mL; mean ± SD at baseline = 39.1% ± 2.4%; month 6 = 44.5% ± 7.0%; P = .04). During the course of the evaluation, mean calcium, albumin, and normalized protein catabolic rate levels did not change significantly. CONCLUSIONS: These results show proof-of-concept that a focused phosphorus management program targeting both staff members and patients can significantly improve patient outcomes without compromising nutritional status.

Examining associations of circulating endotoxin with nutritional status, inflammation, and mortality in hemodialysis patients.

OBJECTIVE: Lipopolysaccharide or endotoxin constitutes most part of the outer portion of the cell wall in the gram-negative bacteria. Subclinical endotoxemia could contribute to increased inflammation and mortality in hemodialysis (HD) patients. Endotoxin level and clinical effect are determined by its soluble receptor sCD14 and high-density lipoprotein. We examine the hypothesis that endotoxin level correlates with mortality. METHODS: In this cohort study, endotoxin levels were measured in 306 long-term HD patients who were then followed up for a maximum of 42 months. Soluble CD14 and cytokines levels were also measured. RESULTS: The mean (±SD) endotoxin level was 2.31 ± 3.10 EU/mL (minimum: 0.26 EU/mL, maximum: 22.94 EU/mL, interquartile range: 1.33 EU/mL, median: 1.27 EU/mL). Endotoxin correlated with C-reactive protein (r = 0.11, P < .04). On multivariate logistic regression analysis, high body mass index and low high-density lipoprotein (HDL) cholesterol levels were associated with higher endotoxemia (endotoxin below or above of median). In multivariate Cox regression analysis adjusted for case-mix and nutritional/inflammatory confounders, endotoxin levels in the third quartile versus first quartile were associated with a trend toward increased hazard ratio for death (hazard ratio: 1.83, 95% confidence interval: 0.93 to 3.6, P = .08). CONCLUSIONS: In this HD cohort, we found associations between endotoxemia and C-reactive protein, body composition, and HDL. Moderately high endotoxin levels tended to correlate with increased mortality than the highest circulating endotoxin level. Additional studies are required to assess the effect of endotoxemia on mortality in dialysis population.

Dietary omega-3 fatty acid, ratio of omega-6 to omega-3 intake, inflammation, and survival in long-term hemodialysis patients.

BACKGROUND: Mortality in long-term hemodialysis patients is high, mostly attributed to cardiovascular events, and may be related to chronic inflammation. We hypothesized that the anti-inflammatory benefits of higher dietary intake of omega-3 compared with omega-6 polyunsaturated fatty acids may modulate the inflammatory processes and decrease death risk. STUDY DESIGN: Prospective cohort study using linear and Cox proportional regressions. SETTING & PARTICIPANTS: 145 hemodialysis patients from 8 DaVita dialysis clinics in Southern California in 2001-2007. PREDICTORS: Intake of dietary omega-3 and ratio of omega-6 to omega-3 using 3-day food record supplemented by dietary interview. OUTCOMES: 1-year change in serum C-reactive protein (CRP) level and 6-year survival. RESULTS: Patients were aged 53 ± 14 years (mean ± SD) and included 43% women and 42% African Americans. Median dietary omega-3 intake, ratio of omega-6 to omega-3 intake, baseline serum CRP level, and change in CRP level over 1 year were 1.1 (25th-75th percentile, 0.8-1.6) g/d, 9.3 (25th-75th percentile, 7.6-11.3), 3.1 (25th-75th percentile, 0.8-6.8) mg/L, and +0.2 (25th-75th percentile, -0.4 to +0.8) mg/L, respectively. In regression models adjusted for case-mix, dietary calorie and fat intake, body mass index, and history of hypertension, each 1-unit higher ratio of omega-6 to omega-3 intake was associated with a 0.55-mg/L increase in serum CRP level (P = 0.03). In the fully adjusted model, death HRs for the first (1.7-<7.6), second (7.6-<9.3), third (9.3-<11.3), and fourth (11.3-17.4) quartiles of dietary omega-6 to omega-3 ratio were 0.39 (95% CI, 0.14-1.18), 0.30 (95% CI, 0.09-0.99), 0.67 (95% CI, 0.25-1.79), and 1.00 (reference), respectively (P for trend = 0.06). LIMITATIONS: 3-day food record may underestimate actual dietary fat intake at an individual level. CONCLUSIONS: Higher dietary omega-6 to omega-3 ratio appears to be associated with both worsening inflammation over time and a trend toward higher death risk in hemodialysis patients. Additional studies including interventional trials are needed to examine the association of dietary fatty acids with clinical outcomes in these patients.

Design and development of a dialysis food frequency questionnaire.

OBJECTIVES: Periodic assessment of dietary intake across a given dialysis population may help to improve the clinical outcomes related to nutrients such as dietary protein, phosphorus, or potassium. Although dietary recalls and food records are used to assess dietary intake at individual level and over shorter periods, food frequency questionnaires (FFQ) are used to rank subjects of a given population according to their nutrient intake over longer periods. DESIGN: To modify and refine the conventional Block FFQ to develop a specific FFQ for dialysis patients. SETTING: A total of 8 DaVita outpatient dialysis clinics in Los Angeles area, which participated in the "Nutrition and Inflammation in Dialysis Patients" study. PATIENTS: The study included 154 patients undergoing maintenance hemodialysis (MHD). MAIN OUTCOME MEASURE: Dietary intake of participating MHD patients using a 3-day food record, supplemented by a person-to-person dietary interview, to capture food intake over the last hemodialysis treatment day of the week and the 2 subsequent nondialysis days. RESULTS: Analyses of the food records identified the key contributors to the daily nutrient intake in the 154 participating MHD patients. A "Dialysis-FFQ" was developed to include approximately 100 food items representing the total food intake of 90% of the patients of the "Nutrition and Inflammation in Dialysis Patients" study population. Distinctions were made in several food items on the basis of key nutritional issues, such as protein, phosphorus, and potassium, in dialysis patients. CONCLUSIONS: We have developed a "Dialysis FFQ" to compare and rank dialysis patients according to their diverse nutrient intake. Although the Dialysis-FFQ may be a valuable tool to compare dialysis patients and to identify those who ingest higher or lower amounts of a given nutrient, studies are needed to examine the utility of the Dialysis-FFQ for nutritional assessment of dialysis patients.

Dietary assessment of individuals with chronic kidney disease.

Examining the quality and quantity of food intake by appropriate methods is critical in the management of patients with chronic kidney disease (CKD). The four commonly used dietary assessment methods in CKD patients include short-term dietary recalls, several days of food records with or without dietary interviews, urea kinetic based estimates such as protein nitrogen appearance calculation, and food histories including food screeners and food frequency questionnaires (FFQ). There are a number of strengths and limitations of these dietary assessment methods. Accordingly, none of the four methods is suitable in and of itself to give sufficiently accurate dietary information for all purposes. Food frequency questionnaires, which is the preferred method for epidemiological studies, should be used for dietary comparisons of patients within a given population rather than individual assessment. Food histories including FFQ and dietary recalls may underestimate important nutrients, especially in CKD patients. Given the large and increasing number of dialysis patients and work responsibilities of renal dietitians, routine analysis of dietary records and recalls is becoming less feasible. Ongoing and future studies will ascertain additional strengths and limitations of dietary assessment methods in CKD populations including the assessment of food intake during an actual hemodialysis treatment.

In-Center Nutrition Practices of Clinics within a Large Hemodialysis Provider in the United States.

BACKGROUND AND OBJECTIVES: Eating during hemodialysis treatment remains a controversial topic. It is perceived that more restrictive practices in the United States contribute to poorer nutritional status and elevated mortality compared with some other parts of the world. However, in-center food practices in the United States have not been previously described. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: In 2011, we conducted a survey of clinic practices and clinician (dietitian, facility administrator, and medical director) opinions related to in-center food consumption within a large dialysis organization. After the initial survey, we provided clinicians with educational materials about eating during treatment. In 2014, we performed a follow-up survey. Differences in practices and opinions were analyzed using chi-squared tests and logistic regression. RESULTS: In 2011, 343 of 1199 clinics (28.6%) did not allow eating during treatment, 222 clinics (18.2%) did not allow drinking during treatment, and 19 clinics (1.6%) did not allow eating at the facility before or after treatment. In 2014, the proportion of clinics that did not allow eating during treatment had declined to 22.6% (321 of 1422 clinics), a significant shift in practice (P<0.001). Among the 178 (6.8%) clinics that self-reported that eating was "more allowed" in 2014, the main reason for this shift was an increased focus on nutritional status. Among clinicians, a higher percentage encouraged eating during treatment (53.1% versus 37.4%; P<0.05), and facility administrators and medical directors were less concerned about the seven reasons commonly cited for restricting eating during treatment in 2014 compared with 2011 (P<0.05 for all). CONCLUSIONS: We found that 28.6% and 22.6% of hemodialysis clinics within the United States restricted eating during treatment in 2011 and 2014, respectively, a rate more than double that found in an international cohort on which we previously published. However, practices and clinician opinions are shifting toward allowing patients to eat. Additional research is warranted to understand the effect that these practices have on patient outcomes and outline best practices.

The Nutritional and Inflammatory Evaluation in Dialysis patients (NIED) study: overview of the NIED study and the role of dietitians.

The absolute majority of maintenance hemodialysis (MHD) patients die within 5 years of commencing dialysis treatment, mostly because of cardiovascular (CV) disease. The strongest and most common correlates of death in MHD patients are not conventional CV risk factors, but markers of protein-energy malnutrition and inflammation, together also known as malnutrition-inflammation complex syndrome (MICS). Paradoxically, classic risk factors such as obesity and hypercholesterolemia are associated with better survival in MHD patients. It has been hypothesized that this so-called reverse epidemiology is caused by the overwhelming prevalence and dominating effect of MICS in MHD patients. Hence, the key to improving survival and quality of life in MHD patients may be a better understanding of MICS and its interactions with CV disease and outcome. The Nutritional and Inflammatory Evaluation in Dialysis Patients (NIED) study is a longitudinal multicenter cohort study that aims to examine these hypotheses. At any given semiannual round, approximately 360 MHD patients from 8 DaVita dialysis facilities in the Los Angeles area are examined; 900 MHD patients will be cumulatively studied by the end of this 5-year prospective study (October 2001 to September 2006). Repeated measures of markers of nutritional status and inflammation are performed by 10 to 12 dialysis unit dietitians while patients attend their routine HD treatment in their dialysis facilities. All-cause and CV mortality, hospitalization, and quality of life are studied as outcome measures. The collaborating dietitians are the main evaluators and play crucial roles in all aspects of the study. This article reviews the design and infrastructure of the NIED study and reports preliminary findings of the first 12 to 30 months of the study.

Academy of Nutrition and Dietetics and National Kidney Foundation: revised 2014 standards of practice and standards of professional performance for registered dietitian nutritionists (competent, proficient, and expert) in nephrology nutrition.

Compelling evidence indicates that the incidence of chronic kidney disease (CKD) is increasing because of an aging population and a higher prevalence of cardiovascular disease, diabetes, and hypertension. Nutrition management of patients with CKD requires early disease recognition, appropriate interpretation of the markers and stages of CKD, and collaboration with other health care practitioners. Better management of CKD can slow its progression, prevent metabolic complications, and reduce cardiovascular related outcomes. Caring for patients with CKD necessitates specialized knowledge and skills to meet the challenges associated with this growing epidemic. The Academy of Nutrition and Dietetics Renal Dietitians Practice Group and the National Kidney Foundation Council on Renal Nutrition, with guidance from the Academy of Nutrition and Dietetics Quality Management Committee, have updated the 2009 Standards of Practice in Nutrition Care and Standards of Professional Performance as a tool for registered dietitian nutritionists working in nephrology nutrition to assess their current skill levels and to identify areas for additional professional development in this practice area. The Standards of Practice apply to the care of patients/clients with kidney disease. The Standards of Professional Performance consist of six domains of professionalism, including: Quality in Practice, Competence and Accountability, Provision of Services, Application of Research, Communication and Application of Knowledge, and Utilization and Management of Resources. Within each standard, specific indicators provide measurable action statements that illustrate how nephrology nutrition principles can be applied to practice. The indicators describe three skill levels (ie, competent, proficient, and expert) for registered dietitian nutritionists working in nephrology nutrition.

Correlates of low hemoglobin A1c in maintenance hemodialysis patients.

PURPOSE: The optimal target for glycemic control has not been established for diabetic maintenance hemodialysis (MHD) patients. METHODS: A 6-year cohort (October 2001- December 2006) of 347 diabetic MHD patients with HbA1c data was examined for associations between HbA1c and mortality. Death hazard ratios (HR) were estimated using Cox regressions and cubic splines. RESULTS: In these 347 patients (age, 59 ± 11 years; 49 % women; 28 % African Americans; and 55 % Hispanics), each 0.5 % decline in HbA1c below 6 % was associated with a 4.7 times higher death risk (HR = 4.7; 95 % CI 1.7-12.7) in the fully adjusted model. Factors associated with lower HbA1c levels (<6 % compared to 6-7 %) were: Hispanic ethnicity (OR = 2.9; 95 % CI 1.1-7.9), higher mid-arm muscle circumstance (OR = 1.1; 95 % CI 1.0-1.3), higher total iron-binding capacity (OR = 1.03; 95 % CI 1.01-1.05), and higher iron saturation ratio (OR = 1.14; 95 % CI 1.03-1.26). HbA1c levels >7 % showed a consistent trend toward elevated mortality risk (HR = 1.18; 95 % CI 0.99-1.41) after multivariate adjustment. CONCLUSIONS: In diabetic MHD patients with burnt-out diabetes, characterized by HbA1c <6 %, even lower HbA1c levels are associated with significantly higher death risk. Additional studies are needed to determine the optimal target for HbA1c levels in different subgroups of diabetic MHD patients.

Relative contributions of inflammation and inadequate protein intake to hypoalbuminemia in patients on maintenance hemodialysis.

PURPOSE: Serum albumin is one of the strongest mortality predictors in maintenance hemodialysis (MHD) patients. Yet, the degree to which serum albumin represents dietary protein intake or an inflammatory state, among others, is not clear. We hypothesize that these inadequate protein intake and inflammation contribute somewhat equally to hypoalbuminemia. METHODS: In a cross-sectional analysis, we examined correlates of low serum albumin, <3.8 g/dL, in 812 MHD patients in whom interleukin-6 (IL-6) and normalized protein nitrogen appearance (nPNA), also known as normalized protein catabolic rate (nPCR), were also measured. Logistic regression estimated odds ratios were employed, and spline models were plotted to examine the likelihood of relatively low serum albumin <3.8 g/dL. RESULTS: Mean age (±SD) of patients was 54 ± 15 years; 53 % of patients were men, 50 % Hispanic, 31 % African-American, and 55 % diabetic. The mean dialysis vintage was 31 ± 34 months (median: 19, inter-quartile range: 7-44 months). The baseline serum albumin, averaged over a 3-month period (mean ± SD), was 3.88 ± 0.38 g/mL. The unadjusted correlation coefficients of l IL-6 and nPNA with serum albumin were -0.36 and +0.20, respectively (p < 0.001 for each comparison). The likelihood for an albumin <3.8 gr/dL increased linearly with decreasing nPNA and rising serum IL-6. This trend was steeper with increasing serum IL-6 up to a concentration of 30 ng/mL. CONCLUSIONS: Both low protein intakes and a high state of inflammation are associated with low serum albumin in MHD patients.

Anti-Inflammatory and Anti-Oxidative Nutrition in Hypoalbuminemic Dialysis Patients (AIONID) study: results of the pilot-feasibility, double-blind, randomized, placebo-controlled trial.

BACKGROUND: Low serum albumin is common and associated with protein-energy wasting, inflammation, and poor outcomes in maintenance hemodialysis (MHD) patients. We hypothesized that in-center (in dialysis clinic) provision of high-protein oral nutrition supplements (ONS) tailored for MHD patients combined with anti-oxidants and anti-inflammatory ingredients with or without an anti-inflammatory appetite stimulator (pentoxifylline, PTX) is well tolerated and can improve serum albumin concentration. METHODS: Between January 2008 and June 2010, 84 adult hypoalbuminemic (albumin <4.0 g/dL) MHD outpatients were double-blindly randomized to receive 16 weeks of interventions including ONS, PTX, ONS with PTX, or placebos. Nutritional and inflammatory markers were compared between the four groups. RESULTS: Out of 84 subjects (mean ± SD; age, 59 ± 12 years; vintage, 34 ± 34 months), 32 % were Blacks, 54 % females, and 68 % diabetics. ONS, PTX, ONS plus PTX, and placebo were associated with an average change in serum albumin of +0.21 (P = 0.004), +0.14 (P = 0.008), +0.18 (P = 0.001), and +0.03 g/dL (P = 0.59), respectively. No related serious adverse events were observed. In a predetermined intention-to-treat regression analysis modeling post-trial serum albumin as a function of pre-trial albumin and the three different interventions (ref = placebo), only ONS without PTX was associated with a significant albumin rise (+0.17 ± 0.07 g/dL, P = 0.018). CONCLUSIONS: In this pilot-feasibility, 2 × 2 factorial, placebo-controlled trial, daily intake of a CKD-specific high-protein ONS with anti-inflammatory and anti-oxidative ingredients for up to 16 weeks was well tolerated and associated with slight but significant increase in serum albumin levels. Larger long-term controlled trials to examine hard outcomes are indicated.

Focused clinical campaign improves mineral and bone disorder outcomes.

As with other disease states, mineral and bone disorder (MBD) management is challenging and may benefit from more systematic management. To evaluate the effectiveness of a focused campaign to improve MBD outcomes, we compared the percentage of patients meeting 2003 Kidney Dialysis Outcomes Quality Initiative (KDOQI)-recommended MBD targets between baseline and 18 months after programme initiation. The four components of the clinical campaign were: (1) a set of grids allowing simultaneous evaluation of MBD test results, (2) a weighted, facility-level cumulative scoring system representing percent of patients within KDOQI-recommended MBD targets, (3) team involvement and (4) patient education. Eighteen months after programme initiation, the percent of patients simultaneously meeting all 2003 KDOQI targets increased 7% and the percent meeting calcium and phosphorus targets increased 24% and 8%, respectively. These findings suggest that a coordinated clinical campaign with effective tools, outcome tracking and sharing and team involvement is an effective strategy to improve MBD outcomes.

FOCUSED CLINICAL CAMPAIGN IMPROVES MINERAL AND BONE DISORDER OUTCOMES.

As with other disease states, mineral and bone disorder (MBD) management is challenging and may benefit from more systematic management. To evaluate the effectiveness of a focused campaign to improve MBD outcomes, we compared the percentage of patients meeting 2003 Kidney Dialysis Outcomes Quality Initiative (KDOQI)-recommended MBD targets between baseline and 18 months after programme initiation. The four components of the clinical campaign were: (1) a set of grids allowing simultaneous evaluation of MBD test results, (2) a weighted, facility-level cumulative scoring system representing percent of patients within KDOQI-recommended MBD targets, (3) team involvement and (4) patient education. Eighteen months after programme initiation, the percent of patients simultaneously meeting all 2003 KDOQI targets increased 7% and the percent meeting calcium and phosphorus targets increased 24% and 8%, respectively. These findings suggest that a coordinated clinical campaign with effective tools, outcome tracking and sharing and team involvement is an effective strategy to improve MBD outcomes.