Prevention of hemodialysis-related muscle cramps by intradialytic use of sequential compression devices: A report of four cases

Background: Hemodialysis (HD)‐related lower extremity (LE) muscle cramps are a common cause of morbidity in end‐stage renal disease patients on maintenance HD. Numerous pharmacologic and physical measures have been tried with variable success rates. Methods: Sequential compression devices (SCD) improve venous return (VR) and are commonly used to prevent LE deep venous thrombosis in hospitals. We hypothesized that LE cramps are triggered by stagnant venous flow during HD and are preventable by improving VR. We prospectively studied four adult patients (mean age 61 ± 14 years) on thrice‐weekly HD who experienced two or more episodes of LE cramping weekly in the month before the study. SCD were applied before each HD on both legs and compressions were intermittently applied at 40 mmHg during treatment. Results: All four patients reported complete resolution of cramping during the study period that lasted 1 month or 12 consecutive dialysis treatments. Conclusion: Application of SCD to LE may prevent the generation of LE HD‐related cramping in a select group of patients. Larger, controlled studies are needed to establish the utility of this noninvasive alternative for the prevention of LE HD‐related cramps.     

Hemodialysis in the Elderly

Background:  Health-related quality of life (HRQOL) is an important outcome of medical treatment effectiveness.
Objectives:  Thirty-six item short-Form (SF-36) first has been used in hemodialysis (HD) patients in Taiwan.
Method:  HRQOL was measured by using SF-36 in 497 HD patients in 5 hospitals.
Results:  Male sex, age less than 50 years, higher education level (EL), marriage, employed status (EPS), less comorbid medical condition (CMC), and non-diabetic patients were all predicted a better physical component scale (PCS). Age less than 50 years, BMI greater than 18.5, HEL, EPS, and NDP were all predicted a higher mental component scale (MCS). Scales contributing to a summary measure of physical health, the PCS score, was significantly lower in women (35 ± 12.3) than in men (37.9 ± 12.3). There is no difference in MCS score between women and men. In multivariate analysis, age, CMC, diabetes, serum creatinine (SCr), and erythropoietin responsiveness were significant independent predictors of PCS. Diabetes, EL, SCr, and erythropoietic responsiveness were significant independent predictors of MCS. All of the individual scales, PCS and MCS scores were lower in the Taiwan HD patients than values for the US general population. Each of the individual scales and MCS scores were substantially lower in Taiwan HD group than in the US HD cohort. But the bodily pain of PCS was significantly higher in Taiwan HD group in spite of mean PCS scores for Taiwan HD group and US HD study participants were nearly equal at 36.3 and 36.1, respectively.
Conclusion:  Physical and mental aspects of quality of life are substantially reduced among Taiwan HD patients, but higher bodily pain tolerance. A number of demographic and clinical characteristics significantly impact on HRQOL in Taiwan HD patients. To our knowledge, this is the first time we demonstrate the HRQOL by using SF-36 in Chinese HD patients.     

Hemodialysis cost in Tehran,Iran

The purpose of this study was to assess the health service cost of hemodialysis (HD) delivered at hospitals in Iran as a developing country with a well‐defined program of renal replacement therapy. A cost analysis was performed from the viewpoint of the 2 hospitals, with 3 shifts and full chairs, on current practice for dialysis maintenance. Cost and patient data were collected in 2006 and from April 1 to May 31, 2007, respectively. A total of 22,464 HD sessions were performed and 247 patients were studied during the study period. The reference year for the value of USD for different mentioned costs was 2006. Health care sector costs associated with each HD session were estimated at US$78.87. Most of the total maintenance expenditure was made up of medical supplies (36.19%), with dialyzers as the major cost driver. Staff salaries represented 17% of the cost and fixed direct capital costs accounted for 21.4%. Of the family members, 32.4% accompanied their patients. The mean cost for transportation of patients and accompanied person was US$3.15 ± 2.83 and US$1.5 ± 0.29, respectively. These findings are important in the light of limited available resources coupled with the increasing prevalence of kidney failure. A major attempt should also be made to increase peritoneal dialysis coverage as in some centers we cannot keep all chairs full, especially in some vast areas. It is highly recommended to place initial focus on strategies and treatments that slow disease progression, to postpone renal replacement therapy to save resources.     

The effect of sexual hormone abnormalities on proximal femur bone mineral density in hemodialysis patients and the possible role of RANKL

Sexual hormone concentrations are commonly affected in chronic renal failure. The contribution of sex steroids to bone turnover regulation implies that sex steroid's dysfunction may be implicated in the emergence of renal osteodystrophy. This study was conducted to evaluate sex steroids and gonadotrophins in hemodialysis (HD) patients and to investigate their role in bone homeostasis in concert with other hormones and cytokines. Bone mineral density (BMD) at the proximal femur and intact parathyroid hormone (iPTH), osteoprotegerin, soluble receptor activator of NF-kappaB ligand (sRANKL), prolactin, total testosterone, estradiol, follicle-stimulating hormone (FSH), and luteinizing hormone (LH) were measured in serum samples in 42 patients, 21 men and 21 women, on maintenance HD therapy. Possible associations between clinical characteristics, biochemical parameters, and BMD values were investigated. In male HD patients, the testosterone concentration declined significantly with aging, whereas the estradiol level increased with longer duration of HD. Concurrently, testosterone correlated negatively with sRANKL concentrations (r=-0.520, p=0.016). Luteinizing hormone levels in male patients demonstrated statistically significant negative correlations with BMD values of the proximal femur. In the entire cohort of patients, FSH and LH were negatively associated with absolute values of proximal femur BMD. Gonadotrophin and sexual hormone concentrations in HD patients are associated with bone mineral status and consequently their derangements appear to contribute to the development of bone composition abnormalities in different types of renal osteodystrophy. Furthermore, testosterone's association with sRANKL levels in male HD patients suggests that RANKL may mediate the effect of testosterone on bone metabolism in these patients.     

The source of net ultrafiltration during hemodialysis is mostly the extracellular space regardless of hydration status

Fluid shifts are common in patients undergoing chronic hemodialysis (HD) during the intradialytic periods, as several liters of fluid are removed during ultrafiltration (UF). Some patients have experienced frequent intradialytic hypotension (IDH). However, the characteristics of fluid shifts and which fluid space is affected remain controversial. Therefore, we designed this study to evaluate the fluid spaces most affected by UF and to determine whether hydration status influences the fluid shifts during HD. This was a prospective cohort study of 40 patients undergoing HD. We measured the patient's fluid spaces using a whole‐body bioimpedance apparatus to evaluate the changes in the fluid spaces before HD and 1–4 hours of HD and 30 minutes after HD. UF achieved during HD by the 40 patients (age, 60.0 ± 5.2 years; 50% men; 50% of patients with diabetes; body weight, 61.3 ± 10.5 kg) was 2.18 ± 0.78 L (measured fluid overload, 2.15 ± 1.24 L). 1) Mean relative reduction of total body water and extracellular water was reduced from the start to the end of HD. 2) However, mean relative reduction of intracellular water was not reduced from the start to the end of HD. 3) No significant differences in fluid shifts were observed according to hydration status. The source of net UF during HD is mostly the extracellular space regardless of hydration status. Thus, IDH may be related to differences in the interstitial fluid shift to the vascular space.     

The International Quotidian Dialysis Registry: annual report 2005

The International Quotidian Dialysis Registry was designed to collect data describing treatments, characteristics, and outcomes of patients treated with quotidian hemodialysis (HD) worldwide. In July 2004, North American centers were first invited to enroll patients. By March 1, 2005, a total of 70 nocturnal and 8 short-daily HD patients from three Canadian and two US centers were enrolled. As recruitment continues, projected enrollment for 2005 may exceed 200 patients from North America alone. Preliminary analyses indicate that the current registry cohort is younger (mean age, 49.5 +/- 1.6 years) and carries a lower burden of comorbidity than the overall North American HD population. The low event rate expected in this cohort underlines the need for a large sample size if an appropriately powered survival study is to be undertaken. Increasing recruitment in the United States by including HD centers owned or managed by large dialysis organizations, and beginning overseas collaborations to include Australia, New Zealand, Europe, and South America will be the primary areas of focus for 2005.     

Implantable cardioverter defibrillator in maintenance hemodialysis patients with ventricular tachyarrhythmias: A single-center experience

Patients with hemodialysis (HD) are at risk of death due to cardiac arrhythmias, worsening congestive heart failure (CHF), and noncardiac causes. This study reviews our experience with the use of implantable cardioverter defibrillators (ICDs) in patients with ventricular tachycardia who are under maintenance HD. We retrospectively reviewed 71 consecutive patients who underwent an ICD implantation in our hospital. There were 11 patients under maintenance HD and 60 patients without HD. The group of patients with HD (HD group) was compared with the patients without HD (control group). The mean follow-up period was 30±9 vs. 39±4 months in the HD group vs. the control group, respectively. Among these patients, 6 in the HD group and 26 in the control group received appropriate ICD therapies. There was no difference in appropriate ICD therapy, time to the first therapy, and electrical storm between the 2 groups. In the HD group, 1 patient underwent surgical removal of the ICD system due to infective endocarditis. There were 5 deaths in the HD group (4 from CHF) and 8 deaths in the control group (4 from CHF). There were no sudden cardiac deaths or arrhythmic deaths in both groups of patients during the follow-up period. However, the overall death rate was significantly higher in the HD group (P<0.01). In HD patients, ICD therapy prevented arrhythmic death, but their rate of nonarrhythmic adverse outcomes was high. This risk-benefit association should be considered before implantation of the device.     

Parathyroidectomized patients have impaired capacity of peripheral vascular constriction during hemodialysis

Parathyroidectomy (PTx) seems to improve cardiovascular outcomes and reduce blood pressure levels. However, the effect of PTx on hemodynamic changes during hemodialysis (HD) is still overlooked. This was a prospective cohort design. Patients with end‐stage renal disease on maintenance HD were included. Diabetes and nonsinusal rhythm were exclusion criteria. History of PTx was recorded. Finometer monitor was used to access parameters immediately pre‐ and post‐HD sessions. Cardiac index (CI) variation (ΔCI) and peripheral arterial resistance variation (ΔPAR) were the variables of interest. Biochemical and echocardiographic data were also obtained. PTx patients (n = 11) were matched to non‐PTx patients (n = 20). ΔPAR was lower in PTx group in comparison with non‐PTx group (P = 0.039), which was independent of parathyroid hormone (PTH) levels. Multiple regression analysis showed that PTx, ΔCI, and dialysate calcium remained independently associated with PAR variation and even adjusted for ultrafiltration rate (adjusted r² = 0.64). In conclusion, parathyroidectomized patients have impaired capacity of vasoconstriction in response to ultrafiltration, an effect independent of serum PTH levels. Further studies are needed to elucidate mechanisms explaining the interaction between PTx and systemic vascular tonus.     

The level of C‐reactive protein in chronic hemodialysis patients: A comparative study between patients with noninfected catheters and arteriovenous fistula in two large Gulf hemodialysis centers

Hemodialysis (HD) patients have greater morbidity and mortality when they have a central venous catheter (CVC) rather than an arteriovenous fistula (AVF) access. Inflammation associated with dialysis catheter use and resultant higher C‐reactive protein (CRP) levels could have an independent adverse effect on patient outcomes. In this prospective study, we investigated whether HD catheters induce inflammation independent of infection. We compared the mean levels of the inflammatory marker (CRP) in 67 patients on maintenance HD using noninfected catheters with 86 HD patients using AVFs at Prince Salman Center for Kidney Diseases, Saudi Arabia (KSA), and Jahra Hospital, Kuwait, who met our inclusion criteria. C‐reactive protein levels were measured every 2 months over a period of 6 months using immunoturbidimetric assay. One hundred fifty‐three patients on maintenance HD for more than 6 months were included in the study, with mean age of 52.19 ± 16.06 years; 66% were males and 34% were females. Serial levels of mean CRP were statistically and significantly higher in group with noninfected catheters (1.33, 1.24, and 1.10 mg/dL) compared to those with AVFs (0.65, 0.59, and 0.68 mg/dL) with P value of 0.000. In our study, we found no relation between CRP level and age, sex, hemoglobin, albumin, calcium, phosphorus, and iPTH level in both groups. Hemodialysis patients with a catheter have a heightened state of inflammation independent of infection, and thus our study supports the avoidance of catheters and a timely conversion to AVFs with catheter removal.     

Evaluation of the oral health status in Chinese hemodialysis patients

Chronic kidney disease has become a worldwide public health problem, and it negatively affects oral health. However, the data of the hemodialysis (HD) patients in Chinese population is unknown. This study was aimed to evaluate the dental health status and oral hygiene behavior of the HD patients in China. Patients undergoing HD therapy at two hospitals were asked to finish a questionnaire and receive dental examination (DMF‐T). A total of 306 patients, aged 24–88 (58.09 ± 14.06), took part in this study. Although majority of the patients (77.78%) brushed their teeth at least twice a day, few (less than 5%) had ever used dental floss or mouthwash. More than half of the patients have not visited a dentist since the commencement of HD therapy. The dental examination showed that DMF‐T was 9.63 ± 7.54, and the number of filled teeth (F‐T) was only 0.70 ± 1.48. Moreover, the average caries restoration ratio and replacement index were 17.57% and 32.59%, respectively. HD therapy seems to prevent patients from visiting a dentist, and there is a great need for dental treatment for Chinese HD patients.     

Plasma fibroblast growth factor-23 levels are independently associated with carotid artery atherosclerosis in maintenance hemodialysis patients

Fibroblast growth factor-23 (FGF-23) has been suggested to play a role in vascular calcification in chronic kidney disease. Common carotid artery intima-media thickness (CIMT) assessment and common carotid artery (CCA) plaque identification using ultrasound are well-recognized tools for identification and monitoring of atherosclerosis. The aim of this study was to test that elevated FGF-23 levels might be associated with carotid artery atherosclerosis in maintenance hemodialysis (HD) patients. In this cross-sectional study, plasma FGF-23 concentrations were measured using a C-terminal human enzyme-linked immunosorbent assay kit. Carotid artery intima-media thickness was measured and CCA plaques were identified by B-Mode Doppler ultrasound. One hundred twenty-eight maintenance HD patients (65 women and 63 men, mean age: 55.5 ± 13 years, mean HD vintage: 52 ± 10 months, all patients are on HD thrice a week) were involved. The mean CIMT were higher with increasing tertiles of plasma FGF-23 levels (0.66 ± 0.14 vs. 0.75 ± 0.05 vs. 0.86 ± 0.20 mm, P<0.0001). Log plasma FGF-23 were higher in patients with plaques in CCA than patients free of plaques (3.0 ± 0.17 vs. 2.7 ± 0.23, P<0.0001). Significant correlation was recorded between log plasma FGF-23 and CIMT (r=0,497, P=0.0001). In multiple regression analysis, a high log FGF-23 concentration was a significant independent risk factor of an increased CIMT. Further studies are needed to clarify whether an increased plasma FGF-23 level is a marker or a potential mechanism for atherosclerosis in patients with end-stage renal disease.     

Prevalence of transfusion-transmitted virus infection in patients on maintenance hemodialysis from New Delhi, India

Transfusion-transmitted virus (TTV) has been reported from a number of hemodialysis (HD) units from various countries throughout the world. TTV has been associated with liver diseases, viral hepatitis B, and C. Clinical details and information regarding TTV prevalence from India are insufficient. The prevalence and clinical significance of TTV infection were studied in New Delhi, India in HD patients. Serum samples were derived from 75 patients on maintenance HD, and 75 age- and sex-matched voluntary blood donors were examined for TTV viremia by nested polymerase chain reaction (PCR) using primers derived from UTR (A) region of the TTV genome. The prevalence of TTV DNA in patients on HD (83%) was significantly (p<0.05) higher than in blood donors (43%). Clinical background including the mean age, sex, mean duration of HD, and mean alanine aminotransferase (ALT) levels did not differ significantly between TTV DNA-positive and -negative HD patients. Fifty-four (72%) TTV-positive HD patients and 7 (56%) TTV-negative HD patients had blood transfusion histories (p>0.05). Among TTV-positive patients, Hepatitis B virus (HBV) co-infection was present in 14.2% cases while hepatitis C virus (HCV) co-infection was absent. Persistent elevation of ALT levels was observed in 7(9.3%) HD patients; 3 (43%) of them were TTV positive and 4 (57%) were TTV negative (p>0.05). All 3 TTV-positive patients with elevated ALT levels were co-infected with HBV. Patients with TTV infection alone showed normal ALT levels. Prevalence of TTV infection is high in North Indian patients on maintenance HD. Also, none of the exclusively TTV DNA-positive patients had clinical or biochemical signs of liver disease. TTV seems to spread through parenteral routes. More often, TTV seems to be associated with parenterally transmitted virus HBV, indicating a parenteral mode of TTV transmission. The pathogenicity of TTV remains unclear from the present study.     

Prognostic significance of 25‐hydroxivitamin D entirely explained by a higher comorbidity burden: Experience from a South‐Eastern European Dialysis Cohort

Vitamin D deficiency is still a common problem particularly in the elderly and in individuals with various degrees of renal impairment. The present study aimed to evaluate the association between plasma concentrations of 25(OH)D and death in a large cohort of prevalent patients on hemodialysis (HD) from south‐east Romania, a typical Balkan region. This is an observational prospective study that included a total of 570 patients on maintenance HD. Study patients were classified into three groups by baseline 25(OH)D levels: (1) sufficient 25(OH)D—i.e., >30 ng/mL; (2) insufficient 25(OH)D—i.e., between 10 and 29 ng/mL; and (3) deficient 25(OH)D—i.e., <10 ng/mL. During the follow‐up period of 14 months, 68 patients (11.9%) died, the Kaplan–Meier analysis showing significant differences in all‐cause mortality for chronic kidney disease patients in different 25(OH)D groups (P = 0.002). Unadjusted Cox regression analysis also showed significant differences in survival. The multivariate Cox regression model showed no significant differences in survival according to vitamin D levels. Hazard ratio for death in the “<10 ng/mL” group was 1.619 (P = 0.190) and in the “10–30 ng/mL” group was 0.837 (P = 0.609). In our dialysis population with a high comorbidity burden, low 25(OH)D concentration was not associated with mortality in the adjusted Cox model, suggesting that vitamin D deficiency could represent only a non‐specific marker for a poor health status, with less impact on mortality.     

Adiponectin and atherosclerosis risk factors in African hemodialysis patients: a population at low risk for atherosclerotic cardiovascular disease

Atherosclerotic cardiovascular disease (CVD) is the major cause of morbidity and mortality in hemodialysis (HD) patients. Adiponectin (ADPN), a recently discovered collagen-like protein, is secreted exclusively by adipocytes. It has anti-atherogenic properties and reduced serum ADPN levels have been shown to be predictive of cardiovascular events. In this study, we determined the atherosclerotic risk and the significance of ADPN levels in our HD patients and also examined its relationship to other traditional CVD risk factors. A cross-sectional study of 84 patients on maintenance HD (58 Blacks and 26 non-Blacks) and 63 healthy controls matched for age, sex and race (35 Blacks and 28 non-Blacks) was undertaken. Serum ADPN levels and other risk factors, including blood pressure, serum lipid, and C-reactive protein, were studied in HD patients and were compared with the controls. Carotid artery intima-media thickness and plaque occurrence was measured by B-mode ultrasonography while echocardiography was done according to American Society of Echocardiography guidelines. Serum ADPN levels were higher in the HD group compared with the control subjects (22.19 ± 0.98 mg/mL vs. 9.93 ± 0.68 mg/mL; P < 0.001). Higher ADPN levels in HD patients were associated with lower triglyceride levels. ADPN correlated positively (r = 0.49, P < 0.0001) with left ventricular mass index (LVMI) in the total study population. ADPN levels were raised in HD patients and correlated with LVMI, possibly because of the confounding effect of low glomerular filtration rate. ADPN levels were inversely related to risk factors for atherosclerosis and may provide possible targets for therapeutic interventions.     

Primary high-dose intradermal hepatitis B vaccination in hemodialysis: cost-effectiveness evaluation at 2 years

Reinforced hepatitis B (HB) vaccination schedules have been tested in nonresponsive hemodialysis (HD) patients. Primary high-dose intradermal (ID) vaccination in HD has been proposed in one study with higher seroconversion rate, but no cost analysis was made. The aim of this prospective study was to confirm this previous report and focus on a cost-effectiveness evaluation of the thorough vaccination with a maintenance program. Thirty-five chronic incident HD patients received primary ID HB vaccination with a reinforced schedule (20 microg Engerix-B every 2 weeks). Revaccination with a monthly single ID dose of 20 microg was performed whenever anti-HBs titer fell under 20 IU/L and continued until a titer of 20 U/L was reached. Outcome measures were cumulative seroconversion rates, mean levels of anti-HBs, maintenance booster doses, rate of seroprotection at the end of the 2-year follow-up and subsequent costs. The present study was associated with an earlier peak of anti-HBs titer (3.9+/-1.7 months) and a higher cumulative seroconversion rate (96.9%) after 1 year. Moreover, a low-booster shot (17.4 microg) of ID Engerix-B/year/patient confers a 100% seroprotection for all responders for a second-year period. The mean cost of our schedule is 127.7 euro/patient for a 2-year period, revaccination included. This current study demonstrates that primary reinforced ID HB vaccination with a maintenance program for a 2-year period warrants the best cost-effectiveness ratio with rapid and sustained seroprotection in almost all HD patients.     

Acute hemodialysis complications in end‐stage renal disease patients: The burden and implications for the under‐resourced Sub‐Saharan African health systems

Little is known about the challenges of routine renal replacement therapy in Sub‐Saharan Africa. We investigated the fatal and nonfatal acute hemodialysis (HD) complications in patients with end‐stage renal disease (ESRD) in two main dialysis centers in Cameroon. 1000 consecutive HD sessions incurred over a 4‐month period by 129 patients (96 men, 74%) with ESRD, receiving two weekly HD sessions of 4 hours each, were considered. Personal and clinical profiles before, during, and within 24 hours after HD sessions were used to diagnose complications. Participants were aged 7 to 80 years (mean 46 years). In all, 452 acute complications were recorded in 411 (41%) of the 1000 HD sessions. Of the 11 types of complications, hypotension (25%), muscular cramps (22%), hypertensive crisis (14%), pruritus (10%), and fever (7%) were the most frequent. Three hundred and six complications (67.7%) occurred during understaffed nighttime. The vascular access was the main bleeding site with 64%. Being diabetic and ultrafiltration rate >1000 mL/h were associated with hypotension and muscle cramps. The shorter duration in dialysis was associated with the risk of bleeding and the disequilibrium syndrome while longer duration was associated with muscle cramps. Four deaths (three from bleeding and one from disequilibrium syndrome) occurred, all during nighttime. Nearly half of dialysis sessions in these settings are associated with acute complications, some of which are fatal. Those complications occurred mostly during understaffed periods. Urgent strategies are needed to quickly solve the human capital crisis in the health care sector.     

Intensive dialysis and blood pressure control: A review

The prevalence of hypertension in hemodialysis (HD) patients has increased over the years. In the early days of maintenance HD blood pressure (BP) control was achieved in most patients. As sessions were shortened, the prevalence of hypertension increased. Yet, in principle, dialysis is able to control hypertension. Today, in programs using long HD, most patients are normotensive without antihypertensive medication. The same is true for patients on daily dialysis, but not for those on short thrice‐weekly HD. In all studies reporting BP normalization, dry weight is regularly achieved. Why the poor control of hypertension now? At first sight the shortened session duration is the culprit. This is suggested by several epidemiologic observations and strongly supported by a prospective experience of changing the HD schedule (short to long HD or conversely) in the same group of patients. Recent studies, however, using strict volume control show that BP normalization can be obtained in conventional 3 x 4 hr/week dialysis with relatively low delivered Kt/V_urea. Therefore, prolonging the dialysis time and/or increasing the dialysis dose are not required to achieve BP control. Intensive dialysis most probably normalizes BP by getting the extracellular volume and the amount of sodium in the body back to normal. It acts in conjunction with a moderate dietary sodium restriction and the use of reasonably low dialysate sodium. With this approach improved BP control can be achieved in the vast majority of HD patients.     

The International Quotidian Hemodialysis Registry: rationale and challenges

Outcomes from conventional thrice-weekly hemodialysis (CHD) are disappointing for a life-saving therapy. The results of the HEMO Study show that the recommended minimum dose (Kt/V) for adequacy is also the optimum attainable with CHD. Interest is therefore turning to alternative therapies exploring the effects of increased frequency and time of hemodialysis (HD) treatment. The National Institutes of Health have sponsored 2 randomized prospective trials comparing short hours daily in-center HD and long hours slow nightly home HD with CHD. An International Registry has also been created to capture observational data on patients receiving short hours daily in-center HD, long hours slow nightly home HD, and other alternative therapies. Participation by individual centers, other registries and the major dialysis chains is growing and currently data from nearly 3000 patients have been collected. Pitfalls in data collection have been identified and are being corrected. A matched cohort (patients in other registries) study is planned to obtain information regarding hard outcomes expected from these therapies. The Registry may become the most important source of information required by governments, providers, and the nephrological community in assessing the utility of such therapies.