Validation of reported predialysis nephrology care of older patients initiating dialysis
Authors: Kim JP, Desai M, Chertow GM, Winkelmayer WC
Journal Citation: J Am Soc Nephrol; published ahead of print April 19, 2012, doi:10.1681/ASN.2011080871

Summary
Nephrologists are required to complete a report on incident end-stage renal disease (ESRD) patients. These data are collected on the Medical Evidence report (Form CMS-2728) and are intended to help inform public health surveillance and policy. In 2005, this form was updated to collect information on the earliest nephrology care received before initiation of dialysis.

The authors assessed the accuracy of the earliest nephrology care data reported on form CMS-2728) in light of the CKD-10 objective of the 2020 Health People Initiative – “Increase the proportion of chronic kidney disease patients receiving care from a nephrologist at least 12 months before the start of renal replacement therapy” (www.healthypeople.gov).  In their analysis, the authors observed discordance between the data reported on this form versus claims data with the level of discordance increasing over time. Further, accuracy varied by patient characteristics.  When the data were assessed according to the criteria of the Healthy People Initiative, the findings of the kappa statistic, a measure of concordance, varied according to the nature of the reference visit from the claims database.  These discrepancies indicate that the data from CMS-2728, as currently reported, may be of less utility to inform public health research than originally intended.  The authors postulate various potential sources for these discrepancies including challenges within the practice and potential ambiguities within the form.  Improving the clarity of the questions may help improve the quality and consistency of data collected thereby improving public health surveillance and research.  Read More…

The influence of initial peritoneal transport characteristics, inflammation, and high glucose exposure on prognosis for peritoneal membrane function
Authors: Fernandez-Reyes MJ, Bajo MA, Del Peso G, Ossorio M, Díaz R, Beatriz C, Selgas R
Journal Citation: Perit Dial Int. Published ahead of print April 2, 2012, doi:10.3747/pdi.2011.00137

Summary
Peritoneal dialysis (PD) can achieve outcomes similar to those of hemodialysis, at least in the medium term and is used in many regions of the world where hemodialysis is not readily available.  Fast transport (FT) status is one complication of peritoneal dialysis and the challenge of using living tissue, other than the kidneys, for dialysis and the associated risk of exposing tissues to bioincompatible fluids. The authors performed a study in 275 PD patients who had at least 2 peritoneal function studies (one at baseline and one at 1 year), looking at the impact of initial peritoneal transport characteristics on the prognosis for peritoneal membrane function.  Their findings indicate that initial FT and ultrafiltration (UF), both identified as complications of PD, are reversible conditions when peritonitis and high glucose levels are avoided.  Both can normalize during the first year on PD. The best predictor of the success of future PD was the mass transfer coefficient of creatinine at 1 year. The authors point out that there is a difference between inherent and acquired FT.  Use of icodextrin provides protection to the peritoneum likely by helping to avoid high glucose levels.  Prognosis for the peritoneal membrane was independent of baseline transport characteristics. These findings suggest that careful management of patients during the first year of PD, such as through avoidance of glucose and peritonitis, can help maintain the integrity of the peritoneal membrane.  Read More..

Slope analysis of blood volume and calf bioimpedance monitoring in hemodialysis patients
Authors:    Seibert E, Zhu F, Kuhlmann MK, Henson R, Oribello AM, Girndt M, Kotanko P, Levin NW.
Journal Citation: Nephrol Dial Transplant. First published online April 12, 2012 doi:10.1093/ndt/gfr734

Summary
Accurately assessing dry weight in patients receiving dialysis can be a challenge. Given the seriousness of fluid overload, various techniques have been evaluated to enable assessment of dry weight and fluid overload. Measurement of extracellular fluid volume (ECV) has proven challenging.  Blood volume can be measured continuously using an online monitor.  Interstitial volume, however, is more challenging.  Calf bioelectrical impedance spectroscopy (BIS), a measure of calf resistance, has been shown to indicate changes in ECV as these decreases in ECV leads to increased resistance. In this study of 15 chronic hemodialysis patients examining calf BIS and blood volume, the pattern of change in calf resistance varied during hemodialysis, with faster changes occurring early in dialysis.  The slope of the calf BIS curve changes steepness once dry weight as per BIS has been achieved.  The authors propose conducting both calf BIS and blood volume monitoring to measure plasma refilling and tissue hydration during dialysis.  Read More..

Increased dietary sodium is independently associated with greater mortality among prevalent hemodialysis patients
Authors: Finnian R Mc Causland, Sushrut S Waikar, and Steven M Brunelli
Journal Citation: Kidney Internat advance online publication. 14 March 2012; doi: 10.1038/ki.2012.42

Summary
Patients undergoing hemodialysis frequently are put on dietary sodium restriction, as sodium is considered contributory to the hypertension, hypervolemia, and mortality observed in these patients.  This treatment has been implemented based on indirect evidence, but without much prospective clinical trial evidence.  Seeking to examine the association between dietary sodium and outcomes in the prevalent hemodialysis population, the authors conducted a post-hoc analysis of data from a large, prospective and well-characterized cohort comprising 1770 patients who participated in the Hemodialysis (HEMO) study and who had the requisite information (dietary, clinical, and laboratory data).  Among the reported findings, authors observed a relationship between higher dietary sodium and higher mortality, as well as greater ultrafiltration requirements, and caloric and protein input.  However, the impact of dietary sodium restrictions on survival in prevalent hemodialysis patients needs to be examined in a randomized clinical trial setting.  Such prospective examination should provide greater clarity on the role of such dietary restrictions in the medical management of prevalent hemodialysis patients. Read More…

Effects of modality change on health-related quality of life
Authors:  Patricia Painter, Joanne B. Krasnoff, Michael Kuskowski, Lynda Frassetto, Kirsten Johansen
Journal Citation:  Hemodialysis Internat.  13 MAR 2012; DOI: 10.1111/j.1542-4758.2012.00676.x

Summary
Physicians have options in modality when treating patients with end-stage renal disease (ESRD), including leaving the modality unchanged, increasing dialysis frequency (daily hemodialysis, DHD) and live donor kidney transplant.  It is well recognized that patients with ESRD have compromised health-related quality of life (HRQOL).  The authors performed a cohort study administering the Kidney Disease Quality of Life instrument at baseline and 6 months after the change in modality in 10 patients who switched to DHD, and 20 patients who received a transplant, compared to 13 patients who remained on conventional hemodialysis and 34 healthy controls.  Patients who had the kidney transplant exhibited HRQOL most similar to the healthy controls, whereas those who switched to DHD exhibited improvements in functioning and physical scales but not in disease related HRQOL scales.  In contrast, those who remained on conventional hemodialysis showed little improvement.  These findings are in many ways consistent with observations of improvements in exercise capacity observed with transplant but not DHD (Painter P, et al. Am J Kidney Dis. 2011;57:113-122).  The authors suggest that, together, these results suggest that changing modalities from standard hemodialysis to transplant resulted in greater improvements in HRQOL, including disease related HRQOL scales and specific physiologic measurements, than did intensifying hemodialysis by implementing DHD.  As HRQOL has been demonstrated to be related to outcomes in these patients, the authors note that improving HRQOL in ESRD patients may be critical and it appears that the modality of transplant offers the best opportunity to improve HRQOL.  Read More…

Hemodialysis and peritoneal dialysis are associated with similar outcomes for end-stage renal disease treatment in Canada
Authors: Karen Yeates, Naisu Zhu, Edward Vonesh, Lilyanna Trpeski, Peter Blake, and Stanley Fenton
Journal Citation: Nephrol. Dial. Transplant. First published online March 5, 2012 doi:10.1093/ndt/gfr674

Summary
Hemodialysis is the most common modality used in North America, despite the comparativeness of outcomes observed with peritoneal dialysis, a home dialysis modality.  The authors sought to determine the current incidence of and survival associated with peritoneal dialysis.  In this paper, the authors describe an analysis of data from the Canadian Organ Replacement Registry comprising all incident dialysis patients between 1991 and 2007.  Over 35,000 patients received renal replacement therapy in Canada during this period (11% on peritoneal dialysis, 49% on hemodialysis, and 40% living with a functional transplant).  The authors observed that in the intent-to-treat analysis of overall survival, peritoneal dialysis was favored during the first 18 months, and hemodialysis after 36 months.  Given that peritoneal dialysis arguable improves quality of life and may represent a lower cost modality, the authors suggest that peritoneal dialysis should be considered when evaluating the appropriate dialysis modality for a given patient.  Read More…

Urgent-Start Peritoneal Dialysis: A Quality Improvement Report
Authors: Arshia Ghaffari
Journal Citation: Am J Kidney Dis. 201;59(3):400-408, doi:10.1053/j.ajkd.2011.08.034.

Summary

Peritoneal dialysis (PD) is a dialysis modality used relatively infrequently in the USA, but more frequently in other areas of the world.  A portion of patients with end-stage renal disease (ESRD), however, need to initiate dialysis before a treatment plan can be developed or before they are able to enter a nephrologist’s care.  The author describes a quality improvement report from a small single-center, nonrandomized study of the outcomes from a structured urgent-start PD program at the LA county and USC medical center between March 2010 and March 2011; this program involved a standardized process including access placement, nurse education, administrative support, and patient education.  Eligible patients had chronic kidney failure (or a transplant recipient whose transplant had failed), required dialysis within 2 weeks, and had no planned modality for long-term dialysis.  In all, 18 patients met these criteria; 9 patients who received non-urgent PD were included as control.  Assessed clinical outcomes within 90-days were measured and were found to be similar between the 2 groups, for all but uncorrected serum calcium levels (which were lower in the urgent-start group, P = 0.02).  Complications were generally similar, with the exception of slightly more frequent minor leaks in the urgent start group.  The authors suggest that, as PD can be a cost-effective form of dialysis, with outcomes similar to hemodialysis, further exploration of the use of PD through a structured program such as the one described here for such a late-referred population with chronic renal failure may be warranted

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Dialyzer Reuse and Mortality Risk in Patients with End-Stage Renal Disease: A Systematic Review
Authors:   Tais Freire Galvao, Marcus Tolentino Silva, Maria Elizete de Almeida Araujo, Wilson Seffair Bulbol, Angela Libia de Melo Pereira Cardoso
Journal Citation:   Am J Nephrol 2012;35:249–258. doi: 10.1159/000336532

Summary
Reuse of dialyzers can be economically beneficial and may prove less wasteful; however, the risks associated with reuse are less clear.  The authors assessed mortality associated with dialyzer reuse in patients with end-stage renal disease (ESRD).  They conducted a systematic review of the published evidence, both in indexed and non-indexed literature.  Of 1190 identified studies, 14 were included in the review, and these describe outcomes in 956,807 patients.  Most of these studies were conducted on retrospective data from the 1980s and 1990s in the USA, a period of time during which conventional dialyzers were commonly used The authors note that all of the studies were observational studies, and of low quality according to the GRADE criteria (ie, Grading of Recommendations Assessment, Development and Evaluation).  The inconsistencies amongst these studies prohibited the ability to do a statistical assessment across the studies.  In all, the authors conclude that reuse of dialyzers does not appear to affect mortality, based on the lack of consistent and significant findings, compared with single use.  The authors point out that these results may not be as translatable to modern dialyzers that use synthetic and more biocompatible membranes as these factors may confound the outcomes.  Finally, the authors argue that better studies, including randomized studies, are required to help inform this question.
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Myocardial microvascular disease and major adverse cardiovascular events in patients with end-stage renal disease: rationale and design of the MICROCARD study
Authors: Theodora Bejan-Angoulvant, Cyrille Bergerot, Laurent Juillard, Aline Mezergues, Emmanuel Morelon, Claire Pouteil-Noble, Xavier Andre-Fouet, and Denis Angoulvant
Journal Citation: Nephrol Dial Transplant (2012) Published online early. doi: 10.1093/ndt/gfs008

Summary
Mortality in patients with end-stage renal disease (ESRD) is often due to cardiovascular disease.  In this patient population, compared with those without ESRD, coronary artery disease appears to differ in its pathophysiology; for example, patients with ESRD tend to have a higher risk of myocardial microvascular disease (MMD) and other cardiovascular symptoms.  The authors describe MICROCARD, an ongoing observational prospective cohort study (Clinicaltrial.gov NCT01291771) investigating the prevalence of myocardial microvascular disease (MMD) and its association with major adverse cardiovascular events (MACE) in patients with ESRD who had a positive non-invasive test for myocardial ischemia (experimental group), compared to patients with ESRD who had a negative test (control group).  Patients in the experimental group will undergo further cardiac assessments.  All patients with ESRD scheduled for a kidney transplant at Lyon University Hospital Centre are referred for evaluation.  Enrolment in this study began in January of 2011, and was planned to end in January 2012. The primary endpoint follow-up will be completed in January 2014.  Patients in the experimental group will be examined in greater detail.  Results from this study, expected in 2014, should provide more insight into coronary artery disease and especially MMD in patients with ESRD.

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Effects of thrice weekly nocturnal hemodialysis on arterial stiffness

Authors: Meltem Sezis Demirci, Gulperi Celik, Mehmet Ozkahya, Murat Tumuklu, Huseyin Toz, Gulay Asci, Soner Duman, Ali Basci, Fatih Kircelli, Oner Ozdogan, Cenk Demirci, Levent Can, Ismet Onder Isik, Ercan Ok, On behalf of the ‘Long Dialysis Group’

Journal Citation:  Atherosclerosis 2012. 220(2): 477-485.
Link to Article    http://www.atherosclerosis-journal.com/article/S0021-9150(11)01084-7/abstract

Summary

Patients with chronic kidney disease, eg, end-stage renal disease, are particularly susceptible to developing serious cardiovascular complications.  These complications may arise from multiple factors such as increased arterial stiffness, possibly resulting from increased fluid overload, increased localized calcium ion levels, hypertension, and arterial calcification.  Altering the frequency and/or length of dialysis sessions may provide better control of these factors.
These investigators describe a prospective, nonrandomized substudy of patients enrolled in the “Long Dialysis Study” (Clinicaltrials.gov ID NCT00413803), a prospective, controlled study of 494 prevalent HD patients receiving thrice weekly 8-hour nocturnal HD (NHD) or thrice weekly 4-hour conventional HD (CHD).  This substudy measured arterial stiffness outcomes in 60 NHD and 60 CHD patients over the 12-month study period.  These patients (mean age, 49 years) had a mean dialysis vintage of 57 months (SD, 47 months).  The two groups were similar in their baseline demographics.
In this study, longer hemodialysis sessions with NHD, compared to CHD, appeared to improve control of both phosphorus and extracellular fluid, resulting in less arterial stiffness, reduced requirements for antihypertensive treatments, and lower calcium-phosphorus product. Based on these results, the authors recommend a randomized controlled study to assess the impact of NHD on hospitalization and death rates.

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Medication Reminder Systems: An Adjunct Technique in Improving Phosphate Binder Adherence

Authors:  Thessaa Obrero Churillo

Journal Citation:   J Ren Nutr 2012; 22(1): e3-e9,. doi:10.1053/j.jrn.2011.10.002

Summary
Poor adherence to prescribed treatment is a common issue across medicine and has been identified as resulting in increased risk of hospitalization and other poor outcomes.  In nephrology, management of hyperphosphatemia is critical to help mitigate the risk of cardiovascular disease among patients with chronic kidney disease (CKD) as directed by KDOQI and KDIGO guidelines.  Typically a regimen of phosphate binders is prescribed.  However, reported compliance with phosphate binder treatment has been poor due to issues including the pill burden in this population, patient ignorance, forgetfulness, and discomfort with the treatment.  Various approaches have been taken in nephrology and other areas of medicine, including improving education, communication, and ease of treatment regimens.
The authors review various electronic approaches that can be employed to help improve patient compliance.  These attempts include prescription reminder services, medication devices with electronic reminders, and mobile applications.  Each approach to help improve patient compliance has different implications for patients, their needs and their resources.  Patient factors need to be considered when deciding what approach to employ.  In the case of management of hyperphosphatemia with phosphate binder treatment, the need to coordinate treatment and meal schedule is an additional complication likely resulting in the need for a multifactorial approach to help ensure patient compliance with treatment.  The ability of these and other approaches to help improve patient compliance in this setting remains to be confirm in a prospective controlled study.

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Making Good on ACOs’ Promise — The Final Rule for the Medicare Shared Savings Program

Authors: Donald M. Berwick

Journal Citation: N Engl J Med 2011; 365:1753-1756

Summary
In 2010, the U.S. Congress enacted the Affordable Care Act of 2010 requiring universal health insurance. As a part of the new law, Accountable Care Organizations, or ACOs, were mandated to provide a path of partnership between health care providers and Medicare and Medicaid. In this perspective, Dr. Donald M. Berwick, until recently the Administrator of the Centers for Medicare and Medicaid Services, details the final rule governing ACOs.
Berwick argues that the current health care system in the U.S. is filled with “inadequate dissemination of usable clinical information, misaligned financial incentives, and in many cases, inertia…[and] barriers to the coordinated care that patients want, providers want to give, and our unsustainable system so desperately needs.” The ACO concept is designed to streamline and improve the delivery of healthcare, giving both shared responsibility and shared reward between the private and public sectors of the industry. The Initial ACO Rule was published in March 2011 and, after much debate and input from the healthcare community, the final rule was issued in October 2011. Ideally, ACOs will help create a new and improved healthcare system with a “patient-centered, coordinated care” focus.

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A Randomized Trial Comparing Gentamicin/Citrate and Heparin Locks for Central Venous Catheters in Maintenance Hemodialysis Patients

Authors: John Moran, Sumi Sun, Ishrag Khababa, Alexander Pedan, Sheila Doss,  and Brigitte Schiller

Journal Citation: Am J Kidney Dis. 2011: xx(x):xxx; DOI:  10.1053/j.ajkd.2011.08.031

Summary

Central venous catheters are commonly used in hemodialysis patients with limited vascular access alternatives. Unfortunately, there remains a high risk of catheter-related infections as well as catheter clotting associated with this access method. In this study, Moran and colleagues compared an antibiotic catheter lock (gentamicin 320 µg/mL in 4% sodium citrate) with a standard catheter lock (heparin 1,000 U/mL) to determine if a low concentration of gentamicin is effective in decreasing the incidence of catheter-related bloodstream infection without systemic gentamicin accumulation.
In this comparative multicenter clinical trial, 303 adults on maintenance hemodialysis across 16 centers of a single large dialysis provider were randomized to receive either the gentamicin antibiotic catheter lock (n = 155) or the standard heparin catheter lock (n = 148). Patients in both groups received the standard neomycin, bacitracin and polymyxin antibiotic ointment treatment at the catheter exit site. The primary endpoints were catheter-related bloodstream infection and catheter clotting.
The investigators found that patients treated with the antibiotic catheter lock had a significantly lower (p = 0.003) catheter-related bloodstream infection rate (0.28 episodes/1,000 catheter-days) than those patients treated with the heparin lock (0.91 episodes/1,000 catheter-days). The number of bacteremia episodes in the antibiotic catheter lock group was 11, compared with 30 in the heparin catheter group. The use of tissue plasminogen activators, indicative of treating catheter-related clotting, was lower, but not significantly so, in the antibiotic lock group (2.36 events/1,000 catheter-days) compared with the heparin group (3.42 events/1,000 catheter-days; p = 0.2).
In this study, the investigators demonstrated the effectiveness of a low-dose gentamicin catheter lock in the prevention of catheter-related infections. Additionally, the antibiotic lock appeared to be as effective as the heparin lock in preventing catheter-related clotting in patients undergoing maintenance hemodialysis.

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Inflammation and the Paradox of Racial Differences in Dialysis Survival

Authors: Deidra C. Crews, Stephen M. Sozio, Yongmei Liu, Josef Coresh, and Neil R. Power

Journal Citation: J Am Soc Nephrol 22: , 2011. DOI:  10.1681/ASN.2011030305

Summary

In this prospective study, Crews et al examined the relationship between inflammation and the apparent differences in survival rates between African-Americans and all patients who have end-stage renal disease (ESRD). An apparent inverse relationship exists for African-Americans who develop ESRD. Although the number of African-Americans with ESRD is higher than the general population (32% vs. 12%), African-Americans have a lower mortality rate than the general population (16% vs. 24% for Caucasians). Investigators wanted to study whether or not inflammation, as measured by C-Reactive Protein (CRP), a common marker for inflammatory conditions, is associated with this phenomenon.
The authors observed 554 Caucasian and 262 African-American patients with incident dialysis across 81 clinics for a median 3-year period, with the actual periods of observation ranging from 4 months to 9.5 years. Overall, they found no significant differences in the CRP levels between the 2 patient populations (Americans and Caucasians (3.4 mg/L in African-Americans compared with 3.9 mg/L in Caucasians). However, there was an observed difference in mortality at 5 years:  34% in African Americans vs. 56% in Caucasians, even when adjusted for confounding factors such as age, sex, diabetes, and comorbidities. Notably, the investigators did find differences in survival based on the CRP levels, with no difference in patients who had low CRP (relative hazard ratio = 1.0) but a significant difference in patients with high CRP (relative hazard ratio = 0.5). Thus, the investigators concluded that inflammation may be a possible factor in improved survival rates for African-Americans with ESRD, but that this may be dependent on the level of inflammation observed in the patient.

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Cardiac Biomarkers and Prediction of ESRD

Authors:   Susanne B. Nicholas

Journal Citation:   Am J Kidney Dis. 2011;58(5):689-691. DOI:  10.1053/j.ajkd.2011.08.013

Summary
In this editorial, Susanne Nicholas (UCLA) reviews the prospect of using biomarkers as prognostic and diagnostic tools in the treatment of kidney disease. In particular, she examines results of 2 biomarkers, troponin T (TnT) and N-terminal pro–B-type natriuretic peptide (NT-pro-BNP), from several clinical trials, including the large-scale TREAT and CRIB studies. These biomarkers are normally associated with cardiovascular complications but may also be of value as prognostic indicators of morbidity and mortality in patients with chronic kidney disease (CKD) and end-stage renal disease (ESRD). Dr. Nicholas makes a strong argument for recognizing the strong association between cardiovascular and kidney diseases, concluding that “based on the evidence that cardiovascular risk may contribute to CKD risk, targeting cardiovascular disease prevention may potentially target CKD prevention as well.”

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Sudden Cardiac Arrest and Sudden Cardiac Death on Dialysis: Epidemiology, Evaluation, Treatment, and Prevention

Authors:   Martin A. Alpert

Journal Citation: Hemodialysis International 2011; 15:S22–S29

Summary

One of the most common causes of death among dialysis patients is cardiac disease, which can account for up to 50% of deaths observed. In this comprehensive review, Martin A. Alpert (University of Missouri) discusses in detail the problems associated with sudden cardiac death in dialysis patients. He outlines the epidemiologic, diagnostic, treatment, and prevention options for dialysis patients at risk of developing these types of cardiovascular comorbidities.

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Erythropoietin-stimulating Agents in Chronic Kidney Disease:
A Response to Hyporesponsiveness

Author: Patrick S. Parfrey
Journal Citation: Seminars in Dialysis—2011. DOI: 10.1111/j.1525-139X.2011.00949.x

Summary

As the debate around the use of ESAs and anemia treatment continues, one of the main issues under discussion is the hyporesponsive reactions to ESAs in certain patients. In this timely editorial, Dr. Patrick Parfrey of Memorial University in Newfoundland, Canada shares his opinions on the possible causes of ESA hyporesponsiveness and some treatment options. Parfrey’s participation in the major clinical studies assessing ESAs in different patient populations, including the Normal Hematocrit Trial, TREAT, and the Canada‑Europe Trial, gives him a wealth of experience from which to make his recommendations. He suggests that there is a relationship between ESA hyporesponsiveness and an increased risk of cardiovascular events. Rather than any particular ESA being the cause, Dr. Parfrey’s opinion is that this relationship may be due to associated co-morbidities as well as the overall general toxicity of ESAs. He concludes with 3 specific recommendations for treating patients who are hyporesponsive to ESAs:

1.      Determining the cause of the hyporesponsiveness

2.      Personalizing the anemia treatment based on the indications of treatment

3.      Controlling the ESA dosage

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Long interdialytic interval and mortality among patients receiving hemodialysis

Authors: Robert N. Foley, David T. Gilbertson, Thomas Murray, and Allan J. Collins
Journal Citation: N Engl J Med 2011; 365:1099-1107

Summary

For dialysis patients undergoing thrice-weekly hemodialysis sessions, a serious concern has always been deviations from normal metabolic and fluid ranges, which may cause cardiovascular complications. One potential source of such variations is the longer interval (2 day versus 1 day interval) between some hemodialysis sessions. In this study of 32,065 patients in the End-Stage Renal Disease Clinical Performance Measures Project, Foley et al assessed the adverse events associated with death and cardiovascular-related hospitalizations between different interdialytic intervals.

Investigators conducted a retrospective analysis of data from a 3-year period, 2005 through 2008, searching for events that occurred on the day of a hemodialysis session after a 2 day interdialytic interval compared with those events that occurred on other days of the week. They reviewed the databases for differences in overall mortality, cause-specific mortality (including cardiac arrest, withdrawal of treatment or uremia, myocardial infarction, septicemia, and stroke), cardiovascular-related hospitalizations, a composite of first hospitalization for cardiovascular related complications, and the individual cardiovascular-related components of the first hospitalization composite.

Patients in this study averaged 2.2 years on dialysis, with 24.2% having received hemodialysis for < 1 year. Investigators found statistically significantly (p < 0.05) higher rates associated with the 2-day interdialytic interval in most of the variables, including all-cause mortality (22.1 versus 18.0 deaths/100 person-years), admissions for myocardial infarction (6.3 versus 3.9), and any cardiovascular event (44.2 versus 19.7). Based on these observations, the investigators concluded that “the long (2-day) interdialytic interval is a time of heightened risk among patients receiving dialysis.”

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Genomics, Health Care, and Society

Authors :  Kathy L. Hudson
Journal Citation:    N Engl J Med 2011; 365:1033-1041

Summary

In this timely review, Dr. Kathy L. Hudson, the Deputy Director for Science, Outreach, and Policy at the National Institutes of Health, assesses a myriad of issues related to the evolving trend of using genetics and genomics in personalized clinical practice. She discusses policies related to “genetic and genomic research, the integration of genetics into clinical care, and the broader issues raised by genetic technologies and information.”

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Bardoxolone Methyl and Kidney Function in CKD with Type 2 Diabetes

Authors:   Pablo E. Pergola, Philip Raskin, Robert D. Toto, Colin J. Meyer, J. Warren Huff, Eric B. Grossman, Melissa Krauth, Stacey Ruiz, Paul Audhya, Heidi Christ-Schmidt, Janet Wittes, and David G. Warnock, for the BEAM Study Investigators*

Journal Citation: N Engl J Med 2011;365:327-36.

Summary: For patients with chronic kidney disease (CKD), diabetes mellitus is both a major cause of the disease and a contributing factor to complications can lead to kidney failure.  Particularly, diabetes in patient with CKD can be associated with chronic inflammation and oxidative stress, in turn leading to glomerular endothelial dysfunction, mesangial-cell contraction, glomerular fibrosis, and mesangial expansion.  These deteriorations ultimately manifest into kidney failure.  Bardoxolone methyl is an antioxidant inflammation modulator that activates the Keap1 Nrf2 pathway associated with the maintenance of kidney function and structure.  Bardoxolone methyl resembles the cyclopentenone prostaglandins structurally and is thought to exert anti-inflammatory effects by inhibiting the proinflammatory NFκB pathway.

In this phase 2, double-blind, randomized, placebo-controlled trial, Pergola and colleagues from the BEAM trial studied whether or not bardoxolone methyl can affect kidney function in patients with CKD.  227 adult patients with CKD (eGFR = 20 to 45 ml/min/1.73 m2 BSA) were assigned to receive placebo or bardoxolone methyl at a target dose of 25, 75, or 150 mg once daily (1:1:1:1 ratio).  The investigators found that patients who received bardoxolone methyl had significant increases (compared with placebo patients) in the mean (±SD) eGFR at 24 weeks:  25 mg group = 8.2±1.5 ml/min/1.73 m2; 75 mg group = 11.4±1.5 ml/min/1.73 m2; 150 mg group = 10.4±1.5 ml/min/1.73 m2; P<0.001).  These increases continued through Week 52 of the study.  Adverse events commonly associated with bardoxolone methyl, including muscle spasms, were generally mild and dose-related; however, hypomagnesemia, mild increases in alanine aminotransferase levels, and gastrointestinal effects were found to be more common among patients receiving bardoxolone methyl.
These results suggest that bardoxolone methyl administration was associated with significant improvement in the eGFR in patients with advanced CKD and type 2 diabetes and may be an effective treatment in this patient population.

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The Effects of Frequent Nocturnal Home Hemodialysis:  The Frequent Hemodialysis Network Nocturnal Trial

Authors:   Michael V. Rocco, Robert S. Lockridge Jr, Gerald J. Beck, Paul W. Eggers, Jennifer J. Gassman, Tom Greene, Brett Larive, Christopher T. Chan, Glenn M. Chertow, Michael Copland, Christopher D. Hoy, Robert M. Lindsay, Nathan W. Levin, Daniel B. Ornt, Andreas Pierratos, Mary F. Pipkin, Sanjay Rajagopalan, John B. Stokes, Mark L. Unruh, Robert A. Star, Alan S. Kliger, and the Frequent Hemodialysis Network (FHN) Trial Group

Journal Citation: Kidney International Advance online publication, 20 July 2011; doi:10.1038/ki.2011.213

Summary: The mortality rates among patients on maintenance hemodialysis remain a significant problem, with an annual average mortality of ~20% over the past 2 decades.  Previous studies, including the NCDS and HEMO studies, have presented conflicting results on this issue.  There are inconclusive data as to whether factors such as dialysis dose and/or frequency of dialysis are associated with morbidity and mortality.  In the current study, Rocco et al set out to determine if an increased hemodialysis frequency could lead to improved patient outcomes, as the increased frequency can result in both an increased clearance of solutes and a reduced interdialytic change in volume.  This increased frequency can be achieved through a short, daily schedule or a longer nocturnal schedule.

Power calculations in designing the study indicated that 250 patients needed to be randomized. However recruitment was difficult and only 87 patients were randomized:  42 enrolled in the conventional hemodialysis arm (3 times/week) and 45 in the frequent nocturnal dialysis arm (6 times/week).  The primary endpoints across both groups included death, change in left ventricular (LV) mass, and the physical health composite (PHC) score.  There was not a significant effect of nocturnal hemodialysis for death or (LV) mass with a hazard ratio of 0.68, or of death or a PHC score with a hazard ratio of 0.91.  The co-primary outcome of combined decrease in mortality and decrease in LV mass did show a positive trend, with a p-value of 0.095. However, here was also a trend for increased vascular access events in patients receiving nocturnal dialysis.

Thus, based on their findings, the investigators concluded that “the results of the FHN Nocturnal Trial neither prove nor disprove the hypothesis that frequent nocturnal dialysis leads to clinically important reductions in LV mass”.

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Dialyzer Reuse and Peracetic Acid and Patient Mortality

Authors: T. Christopher Bond, Allen R. Nissenson, Mahesh Krishnan, Steven M. Wilson, Tracy Mayne

Journal Citation: CJASN. May 2011; DOI: 10.2215/CJN.10391110; Published online before print.

Summary: The clinical impact of dialyzer filter reuse has been debated since the 1960s, with the consensus being this common practice has no adverse effects on patients.  A 2010 study by Lacson and colleagues found a significant increased mortality risk at dialyzer reuse filter dialysis centers compared with single-use filter dialyzer centers.  The current study sought to clarify these earlier findings of the association between dialyzer reuse and patient mortality through a series of retrospective analyses (instrumental variables, propensity-score matching, time‑dependent survival analysis) of data from over 400 dialysis centers in a population of over 27,000 in-center hemodialysis patients.

Bond et al found no meaningful relationship between dialyzer reuse and mortality.  There was no statistically significant difference in the mortality rate between single-use centers and reuse centers:  the mortality rate was 13.33% at single-use centers and 13.71% at reuse centers.  This comparability remained consistent, again with no statistically significant difference, when adjusted with propensity-score matching (12.93% mortality at single-use centers versus 12.96% at reuse centers). Thus, Bond et al concluded that their analyses confirmed the reuse of dialyzers did not negatively impact patient mortality

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When Enough Is Enough: The Nephrologist’s Responsibility In Ordering Dialysis Treatments

Authors: Michael J. Germain, Sara N. Davison, and Alvin H. Moss

Journal Citation: Am J Kid Dis (2011) doi:10.1053/j.ajkd.2011.03.019; Article in press

Summary: As the dialysis patient population continues to grow older, multiple questions can be raised with regard to the appropriateness of dialysis in elderly patients.  In this thought-provoking review, Germain and colleagues discuss the medical, ethical, legal, and personal aspects of elderly dialysis treatment.  In comparing the 2 treatment paradigms, the standard dialysis treatment regimen versus the “conservative” treatment regimen where alternatives to dialysis are used, the authors suggest that the time is at hand for a re-evaluation of the standard of care for older end stage renal disease patients.  The authors suggest a move away from the “one-size-fits-all” dialysis approach.  Rather, they emphasize that a customized, or individualized, holistic treatment regimen based on the elderly patient’s overall clinical condition, quality of life, and cultural sensitivities.

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Cost-Effectiveness Analysis of a Randomized Trial Comparing Care Models for Chronic Kidney Disease

Authors: RB Hopkins, AX Garg, A Levin, A Molzahn, C Rigatto, J Singer, G Soltys, S Soroka, PS Parfrey, BJ Barrett, and R Goeree

Journal Citation: Clin J Am Soc Nephrol (2011) 6: 1248–1257, 2011. doi: 10.2215/CJN.07180810

Summary: In this Canadian study from the CanPREVENT trial, Hopkins et al examined the potential cost effectiveness of a nephrologist/nurse–based chronic disease management model for patients with Stage 3 to 4 chronic kidney disease.  The investigators examined the hypothesis that a proactive, nurse-coordinated multi-risk factor intervention clinic involving a nephrologist and focusing on applying evidence-based treatments in patients with CKD can reduce or delay the onset of advanced kidney and cardiovascular disease.  Results over 2 years across 5 Canadian dialysis centers were based on 236 patients who received standard of care and 238 patients who received the nephrologist/nurse-based chronic disease management care.

The investigators found that there were statistically significant cost savings with the proactive nephrologist/nurse management model compared with the standard of care model.  A lower number of days in hospitalization was the dominant cause for the difference.  For both base-case and sensitivity analyses with all costs included, patients treated with the management model required fewer resources and had a higher quality of life.  Thus, the investigators concluded that a proactive, nephrologist/nurse–based multifaceted intervention management model represents good value for money because it reduces costs without reducing quality of life for patients with chronic kidney disease.

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Fatal and Nonfatal Outcomes, Incidence of Hypertension, and Blood Pressure Changes in Relation to Urinary Sodium Excretion

Authors: Katarzyna Stolarz-Skrzypek, Tatiana Kuznetsova, Lutgarde Thijs, Vale´rie Tikhonoff, Jitka Seidlerova´, Tom Richart, Yu Jin, Agnieszka Olszanecka, Sofia Malyutina, Edoardo Casiglia, Jan Filipovsky´, Kalina Kawecka-Jaszcz, Yuri Nikitin, Jan A. Staessen, for the European Project on Genes in Hypertension (EPOGH) Investigators

Journal Citation: JAMA. 2011;305(17):1777-1785

Summary: Surprising results with regard to the relationship between salt intake and cardiovascular disease were found in this collaborative study between Belgian and Polish investigators.  In this study with over 3500 participants, Stolarz‑Skrzypek and colleagues found that higher sodium intake was not necessarily related to increased cardiovascular events.  Rather, the data demonstrated a statistically significant (P < 0.001), inverse relationship between levels of 24-hour sodium excretions and cardiovascular-related deaths:  low sodium (107 mmol) = 4.1% (50 deaths); medium sodium (168 mmol) = 1.9% (24 deaths); and high sodium (260 mmol) = 0.8% (10 deaths).  Additionally, they found that baseline sodium levels were not predictive of mortality or nonfatal cardiovascular events.  Finally, they also found that increased risks in hypertension and cardiovascular complications were not correlated with sodium levels.  Taken together, these findings question previous results and predictive models that established a relationship between high salt intake and increased cardiovascular morbidity and mortality.

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The effect of sevelamer carbonate and lanthanum carbonate on the pharmacokinetics of oral calcitriol

Authors: David Pierce, Stuart Hossack, Lynne Poole, Antoine Robinson, Heather Van Heusen, Patrick Martin, and Michael Smyth

Journal Citation: Nephrol Dial Transplant (2011) 26: 1615–1621;doi: 10.1093/ndt/gfq598

Summary: In this cross-over, 3-period study in 41 healthy volunteers, Pierce and colleagues studied the effects of lanthanum carbonate and sevelamer carbonate on the bioavailability of oral calcitriol.  The investigators found that co-administration of lanthanum carbonate did not have any significant effects on serum concentrations of calcitriol at 48 hours (AUC_0-48h) not were there significant changes in the maximum concentration (C_max).  Concomitant administration of sevelamer carbonat with calcitriol, however, did result in significant reductions in the AUC_0-48h(137 pg h/mL [calcitriol with sevelamer carbonate] 318 pg h/mL [calcitriol monotherapy]; P = 0.024) and C_max( 40.1 pg/mL vs 49.7 pg/mL, respectively; P < 0.001).  These findings suggest that physicians should exercise caution in the choice of Vitamin D supplements for CKD patients.

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Prevention of catheter-related bloodstream infection in patients on hemodialysis

Authors: Michiel G. H. Betjes

Journal Citation: Nat. Rev. Nephrol. 7, 257–265 (2011); published online 22 March 2011; doi:10.1038/nrneph.2011.28

Summary: This review finds Michiel Betjes presenting a comprehensive discussion on the substantial problem of catheter-related blood stream infections (CRBSIs) resulting from the use of central venous catheters (CVCs) in hemodialysis patients.  Betjes first reviews the results from several CVC infection prevention studies, conducted in both the dialysis and nondialysis settings.  Based on the data, Betjes then outlines a recommended CVC care protocol and surveillance program to minimize the risk of CRBSIs.  The key features of both programs include prevention of intraluminal contamination of the CVC, strict aseptic CVC insertion and handling, chlorhexidine/alcohol solution use for skin cleansing, topical application of antimicrobial ointments, and antimicrobial lock solutions.  Finally, Betjes suggests that following and maintaining these suggestions may lead to an achievement of a CRBSI incidence of < 1 episode/1,000 catheter days.

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