Naturally occurring higher hemoglobin concentration does not increase mortality among hemodialysis patients.

A small percentage of hemodialysis patients maintain higher hemoglobin concentrations without transfusion or erythropoietic therapy. Because uncertainty exists regarding the effects of higher hemoglobin concentration on mortality and quality of life among hemodialysis patients, studying this group of patients with sufficient endogenous erythropoietin may provide additional insights. The prospective, observational Dialysis Outcomes and Practice Patterns Study provides an opportunity to investigate this group. Among 29,796 patients in 12 nations, 545 (1.8%) maintained hemoglobin concentrations >12 g/dl for 4 months without erythropoietic support. This subset tended to be male, to have a longer duration of end-stage renal disease, and to not dialyze via a catheter. Cystic disease as the underlying cause of renal failure was over-represented in this group but was present in only 25%. Lung disease, smoking, and cardiovascular disease were associated with increased likelihood of naturally higher hemoglobin concentration. Quality-of-life scores were not higher among this subset compared with the other patients. Unadjusted mortality risk for patients with hemoglobin >12 g/dl and no erythropoietic therapy was lower than for the other patients, but after thorough adjustment for case mix, there was no difference between groups (relative risk, 0.98; 95% CI 0.80 to 1.19). These data show that naturally occurring hemoglobin concentration >12 g/dl does not associate with increased mortality among hemodialysis patients.

Health-related quality of life and hemoglobin levels in chronic kidney disease patients.

BACKGROUND: The relationship between quality of life (QofL) and anemia has been the subject of recent debates; it has been suggested that the QofL changes associated with the treatment of anemia of chronic kidney disease (CKD) or ESRD patients should not be used in making decisions to treat anemia in CKD patients. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: This study examines the relationship between Kidney Disease Quality of Life (KDQofL) questionnaire domains and hemoglobin (Hgb) levels in 1200 patients with stage 3, 4, and 5 CKD followed in seven centers. QofL measures were compared in a stepwise fashion for hemoglobin levels of <11, 11 to <12, 12 to <13, and > or =13. ANOVA was used to examine the relationship between QofL scores and Hgb level, age, CKD stage, and albumin level; a history of diabetes, congestive heart failure, or myocardial infarction; use of erythropoetic-stimulating agents (ESA); and the interaction of hemoglobin level and ESA. RESULTS: The results demonstrate that with increasing Hgb levels there is a statistically significant increase in all four physical domains, the energy/vitality domain, and the physical composite score of the SF-36, and the general health score on the kidney disease component of the questionnaire. The most dramatic improvements in these various domains occurred between the <11 and the 11 to 12 group. CONCLUSIONS: Higher Hgb levels are associated with improved QofL domains of the KDQofL questionnaire. These findings have implications for the care of CKD patients in terms of the initiation of and the Hgb target of ESA therapy.

Vascular access use and outcomes: an international perspective from the Dialysis Outcomes and Practice Patterns Study.

BACKGROUND: A well-functioning vascular access (VA) is essential to efficient dialysis therapy. Guidelines have been implemented improving care, yet access use varies widely across countries and VA complications remain a problem. This study took advantage of the unique opportunity to utilize data from the Dialysis Outcomes and Practice Patterns Study (DOPPS) to examine international trends in VA use and trends in patient characteristics and practices associated with VA use from 1996 to 2007. DOPPS is a prospective, observational study of haemodialysis (HD) practices and patient outcomes at >300 HD units from 12 countries and has collected data thus far from >35,000 randomly selected patients. METHODS: VA data were collected for each patient at study entry (1996-2007). Practice pattern data from the facility medical director, nurse manager and VA surgeon were also analysed. RESULTS: Since 2005, a native arteriovenous fistula (AVF) was used by 67-91% of prevalent patients in Japan, Italy, Germany, France, Spain, the UK, Australia and New Zealand, and 50-59% in Belgium, Sweden and Canada. From 1996 to 2007, AVF use rose from 24% to 47% in the USA but declined in Italy, Germany and Spain. Moreover, graft use fell by 50% in the USA from 58% use in 1996 to 28% by 2007. Across three phases of data collection, patients consistently were less likely to use an AVF versus other VA types if female, of older age, having greater body mass index, diabetes, peripheral vascular disease or recurrent cellulitis/gangrene. In addition, countries with a greater prevalence of diabetes in HD patients had a significantly lower percentage of patients using an AVF. Despite poorer outcomes for central vein catheters, catheter use rose 1.5- to 3-fold among prevalent patients in many countries from 1996 to 2007, even among non-diabetic patients 18-70 years old. Furthermore, 58-73% of patients new to end-stage renal disease (ESRD) used a catheter for the initiation of HD in five countries despite 60-79% of patients having been seen by a nephrologist >4 months prior to ESRD. Patients were significantly (P < 0.05) less likely to start dialysis with a permanent VA if treated in a faciity that (1) had a longer time from referral to access surgery evaluation or from evaluation to access creation and (2) had longer time from access creation until first AVF cannulation. The median time from referral until access creation varied from 5-6 days in Italy, Japan and Germany to 40-43 days in the UK and Canada. Compared to patients using an AVF, patients with a catheter displayed significantly lower mean Kt/V levels. CONCLUSIONS: Most countries meet the contemporary National Kidney Foundation's Kidney Disease Outcomes Quality Initiative goal for AVF use; however, there is still a wide variation in VA preference. Delays between the creation and cannulation must be improved to enhance the chances of a future permanent VA. Native arteriovenous fistula is the VA of choice ensuring dialysis adequacy and better patient outcomes. Graft is, however, a better alternative than catheter for patients where the creation of an attempted AVF failed or could not be created for different reasons.

The economics of end-stage renal disease care in Canada: incentives and impact on delivery of care.

Examining international differences in health outcomes for end-stage renal disease (ESRD) patients requires an understanding of ESRD funding structures. In Canada, funding for all aspects of dialysis and transplant care, with the exception of drugs (for which supplementary insurance can be purchased), is provided for all citizens. Although ESRD programs across Canada's 10 provinces differ in funding structure, they share important economic characteristics, including being publicly funded and universal, and providing most facets of ESRD care for free. This paper explains how ESRD care fits into the Canadian health care system, describes the epidemiology of ESRD in Canada, and offers economic explanations for international discrepancies.

Diagnosis and management of insomnia in dialysis patients.

Sleep-related complaints affect 50-80% of patients on dialysis. Sleep disorders impair quality of life significantly. Increasing evidence suggests that sleep disruption has a profound impact both on an individual and on a societal level. The etiology of sleep disorders is often multifactorial: biologic, social, and psychological factors play a role. This is especially true for insomnia, which is the most common sleep disorder in different populations, including patients on dialysis. Biochemical and metabolic changes, lifestyle factors, depression, anxiety, and other underlying sleep disorders can all have an effect on the development and persistence of sleep disruption, leading to chronic insomnia. Insomnia is defined as difficulty initiating or maintaining sleep, or having nonrestorative sleep. It is also associated with daytime consequences, such as sleepiness and fatigue, and impaired daytime functioning. In most cases, the diagnosis of insomnia is based on the patient's history, but in some patients objective assessment of sleep pattern may be necessary. Optimally the treatment of insomnia involves the combination of both pharmacologic and nonpharmacologic approaches. In some cases acute insomnia resolves spontaneously, but if left untreated, it may lead to chronic sleep problems. The treatment of chronic insomnia is often challenging. There are only a few studies specifically addressing the management of this sleep disorder in patients with chronic renal disease. Considering the polypharmacy and altered metabolism in this patient population, treatment trials are clearly needed. This article reviews the diagnosis of sleep disorders with a focus on insomnia in patients on dialysis.

Haemodialysis vascular access problems in Canada: results from the Dialysis Outcomes and Practice Patterns Study (DOPPS II).

BACKGROUND: The optimal vascular access for chronic maintenance haemodialysis (HD) is the native arteriovenous fistula (AVF). Vascular access practice patterns are reported for a Canadian cohort of patients from the Dialysis Outcomes and Practice Patterns Study (DOPPS II). METHODS: DOPPS II is a prospective, observational study in 12 countries, including Canada. A representative random sample of 20 Canadian HD facilities and patients within those units were studied during 2002-2004. Canadian results were compared with those found in Europe and the USA. RESULTS: AVF use in Canadian prevalent (53%) and incident (26%) patients was lower than Canadian guidelines recommend (60%), and lower than in Europe [prevalent (74%), incident (50%)]. Despite 85% of Canadian HD patients having seen a nephrologist for > 1 month prior to starting dialysis, central venous catheter use in Canada (33% in prevalent patients, 70% in incident patients) was much higher than in Europe (prevalent 18%, incident 46%) and slightly higher than in the USA (prevalent 25%, incident 66%). This pattern is contrary to the preferences of Canadian medical directors and vascular access surgeons. The typical time from referral until permanent vascular access creation is substantially longer in Canada (61.7 days) than in Europe (29.4 days) or the USA (16 days). This longer delay time and higher catheter use in Canada may be a consequence of the significantly lower number of access surgeons per 100 HD patients in Canada (2.9) compared with the USA (8.1) and Europe (4.6). Furthermore, the median hours per week devoted to vascular access-related surgery per 100 patients is substantially lower in Canada (0.027 h) compared with the USA (0.082 h) and Europe (0.059 h). CONCLUSION: These findings suggest that Canadian chronic HD patients often rely on central venous catheters for vascular access, despite their known association with numerous detrimental outcomes in HD. Nephrologists, vascular access surgeons, interventional radiologists, other physicians and health care funding bodies must be more broadly educated about the priority of AVF creation as the preferred vascular access for chronic HD patients. They must work together to secure both the human and financial resources and other health care system enhancements to increase AVF creation rates in a timely manner.

A cross-sectional immunosurveillance study of anti-EPO antibody levels in CRF patients receiving epoetin alfa in 5 Ontario Renal Centers.

BACKGROUND: Epoetin alfa (Eprex*; Johnson & Johnson, Manati, PR) has been used successfully to correct the anemia of chronic renal failure for more than 12 years. Anti-erythropoietin (anti-EPO) antibodies have been reported in a small number of patients, resulting in a blood disorder, pure red cell aplasia (PRCA). To evaluate the utility of a large-scale anti-EPO antibody screening program in patients with chronic kidney disease (CKD) administered epoetin alfa, a study involving 5 large renal centers in southern Ontario, Canada, was conducted. METHODS: More than 1,500 hemodialysis, peritoneal dialysis, and predialysis patients were screened for the prevalence of anti-EPO antibodies by means of a radioimmunoprecipitation (RIP) assay. Serum samples were drawn and shipped to PPD Development (Richmond, VA) for the immunoprecipitation assay. Serum EPO levels also were measured. All samples that tested positive or borderline for antibodies were sent to MDS Pharma Services (Montreal, Canada) for the neutralization assay. RESULTS: Of 1,531 samples tested, 1 patient tested low-positive and 3 borderline results were detected by means of RIP. PRCA previously was diagnosed in the patient with the low-positive antibody level; the patient was treated with cyclosporine and currently is being administered epoetin alfa with good response. The 3 patients with borderline antibody results manifested no clinical signs of PRCA. Neutralization assays performed on all 4 serum samples were negative for anti-EPO antibodies. CONCLUSION: Results from this surveillance study show that the prevalence of antibody to EPO in patients with CKD administered epoetin alfa in 5 Canadian renal centers is low, and the value of a large-scale antibody screening program for PRCA cannot be justified.