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Journal ArticleDOI

Survival with Three-Times Weekly In-Center Nocturnal Versus Conventional Hemodialysis

TL;DR: Conversion to treatment with nocturnal hemodialysis associates with favorable clinical features, laboratory biomarkers, and improved survival compared with propensity score-matched controls, notwithstanding the possibility of residual selection bias.
Abstract: Whether the duration of hemodialysis treatments improves outcomes remains controversial. Here, we evaluated survival and clinical changes associated with converting from conventional hemodialysis (mean=3.75 h/treatment) to in-center nocturnal hemodialysis (mean=7.85 h/treatment). All 959 consecutive patients who initiated nocturnal hemodialysis for the first time in 77 Fresenius Medical Care facilities during 2006 and 2007 were eligible. We used Cox models to compare risk for mortality during 2 years of follow-up in a 1:3 propensity score–matched cohort of 746 nocturnal and 2062 control patients on conventional hemodialysis. Two-year mortality was 19% among nocturnal hemodialysis patients compared with 27% among conventional patients. Nocturnal hemodialysis associated with a 25% reduction in the risk for death after adjustment for age, body mass index, and dialysis vintage (hazard ratio=0.75, 95% confidence interval=0.61–0.91, P=0.004). With respect to clinical features, interdialytic weight gain, albumin, hemoglobin, dialysis dose, and calcium increased on nocturnal therapy, whereas postdialysis weight, predialysis systolic blood pressure, ultrafiltration rate, phosphorus, and white blood cell count declined (all P<0.001). In summary, notwithstanding the possibility of residual selection bias, conversion to treatment with nocturnal hemodialysis associates with favorable clinical features, laboratory biomarkers, and improved survival compared with propensity score–matched controls. The potential impact of extended treatment time on clinical outcomes while maintaining a three times per week hemodialysis schedule requires evaluation in future clinical trials.

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Citations
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Journal ArticleDOI
TL;DR: The 2015 update of the KDOQI Clinical Practice Guideline for Hemodialysis Adequacy is intended to assist practitioners caring for patients in preparation for and during hemodialysis.

722 citations


Cites background from "Survival with Three-Times Weekly In..."

  • ...The Work Group also recognizes that cost or staffing considerations may affect the ability of an individual dialysis center to provide in-center short frequent HD. Finally, these recommendations do not apply to short home HD therapies or to dialysis prescriptions that are substantially dissimilar (eg, slow dialysate flow rates) to the FHN Daily Study prescriptions....

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  • ...This study’s findings were refuted by the same authors some years later with a newer analysis showing that all types of kidney transplantation had superior survival compared to home long frequent HD.121 Preliminary data from extended follow-up of participants in the FHN Nocturnal Trial showed no survival benefit, and possibly an increase in mortality with home long frequent HD.116 It is difficult to interpret these mortality data given the high nonadherence rate with home long frequent treatment, as well as the large percentage of crossovers in both arms after the main trial ended.116 Additional data on causes of death and hospitalization in this extended follow-up period have not yet been reported....

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  • ...Mean differences in these variables (frequent minus conventional groups) were: 213.8 g, 10.1 mm Hg, 20.64 medications per day, 20.46 mg/dL, and 21.35 g equivalent phosphate-binder doses per day).9,99,100 On the other hand, there were no improvements in serum albumin levels,101 cognitive function as measured by the Trailmaking Test Part B,102 depression as measured by the Beck Depression Inventory, mental health as measured by the mental health composite of the RAND,103 or objective measures of physical performance.104 Hemoglobin levels decreased by a mean of 0.29 mg/dL in the conventional group compared to a stable hemoglobin level in the more frequent group (P 5 0.03), while there was no difference in doses of erythropoiesis-stimulating agents (ESAs).105 The FHN Daily Trial also identified certain risks associated with in-center short frequent HD. Compared with patients receiving conventional HD, 904 patients randomized to in-center short frequent HD had a statistically significant increased risk of vascular access repairs (hazard ratio [HR], 1.68; 95% confidence interval [CI], 1.13-2.51; P 5 0.01), primarily driven by increased vascular access repairs in the subgroup of patients with AV accesses at baseline.106 All types of repairs appeared to be more prevalent with frequent compared to conventional HD, including angioplasties, thrombectomies, and surgical revisions....

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  • ...To date, just 1 randomized trial of short frequent HD has been completed.9 The Work Group is unaware of any randomized trials of home short frequent HD and thus the group developed guideline statements only for in-center short frequent HD....

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  • ...The Work Group for the KDIGO Controversies Conference on “Novel Techniques and Innovation in Blood Purification” noted that there is no uniform nomenclature to describe the different types of intensive or more frequent HD.91 Given the multitude of terms in the literature (eg, daily, nocturnal, short daily, daily nocturnal, quotidian, frequent, and intensive), it is often difficult to identify studies evaluating similar HD prescriptions....

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Journal ArticleDOI
TL;DR: There is an emerging HD dose-effect in Australia and New Zealand, with lower mortality risks associated with some of the more intensive HD regimens in these countries.

181 citations

Journal ArticleDOI
TL;DR: The application of a hollow fiber mixed matrix membrane (MMM) for removal of end stage renal disease waste solutes has permeation properties in the ultrafiltration range and it is estimated that these membranes would suffice to remove the daily production of these protein bound solutes.

125 citations


Cites background from "Survival with Three-Times Weekly In..."

  • ...Despite considerable amounts of healthcare budgets spent on renal replacement therapy [3,4], mortality of dialysis patients remains high [5,6] and their overall health related quality of life low [7]....

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Journal ArticleDOI
TL;DR: Treatment with the wearable artificial kidney was well tolerated and resulted in effective uremic solute clearance and maintenance of electrolyte and fluid homeostasis, serving as proof of concept that, after redesign to overcome observed technical problems, a wearable artificial kidneys can be developed as a viable novel alternative dialysis technology.
Abstract: BACKGROUND. Stationary hemodialysis machines hinder mobility and limit activities of daily life during dialysis treatments. New hemodialysis technologies are needed to improve patient autonomy and enhance quality of life. METHODS. We conducted a FDA-approved human trial of a wearable artificial kidney, a miniaturized, wearable hemodialysis machine, based on dialysate-regenerating sorbent technology. We aimed to determine the efficacy of the wearable artificial kidney in achieving solute, electrolyte, and volume homeostasis in up to 10 subjects over 24 hours. RESULTS. During the study, all subjects remained hemodynamically stable, and there were no serious adverse events. Serum electrolytes and hemoglobin remained stable over the treatment period for all subjects. Fluid removal was consistent with prescribed ultrafiltration rates. Mean blood flow was 42 ± 24 ml/min, and mean dialysate flow was 43 ± 20 ml/min. Mean urea, creatinine, and phosphorus clearances over 24 hours were 17 ± 10, 16 ± 8, and 15 ± 9 ml/min, respectively. Mean β2-microglobulin clearance was 5 ± 4 ml/min. Of 7 enrolled subjects, 5 completed the planned 24 hours of study treatment. The trial was stopped after the seventh subject due to device-related technical problems, including excessive carbon dioxide bubbles in the dialysate circuit and variable blood and dialysate flows. CONCLUSION. Treatment with the wearable artificial kidney was well tolerated and resulted in effective uremic solute clearance and maintenance of electrolyte and fluid homeostasis. These results serve as proof of concept that, after redesign to overcome observed technical problems, a wearable artificial kidney can be developed as a viable novel alternative dialysis technology. TRIAL REGISTRATION. ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT02280005","term_id":"NCT02280005"}}NCT02280005. FUNDING. The Wearable Artificial Kidney Foundation and Blood Purification Technologies Inc.

106 citations

Journal ArticleDOI
TL;DR: These results should be interpreted cautiously due to a surprisingly low (0.03 deaths/patient-year) mortality rate for individuals randomly assigned to conventional home hemodialysis, low statistical power for the mortality comparison due to the small sample size, and the high rate of he modialysis prescription changes.

81 citations

References
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Journal ArticleDOI
TL;DR: Patients undergoing hemodialysis thrice weekly appear to have no major benefit from a higher dialysis dose than that recommended by current U.S. guidelines or from the use of a high-flux membrane.
Abstract: Background The effects of the dose of dialysis and the level of flux of the dialyzer membrane on mortality and morbidity among patients undergoing maintenance hemodialysis are uncertain. Methods We undertook a randomized clinical trial in 1846 patients undergoing thrice-weekly dialysis, using a two-by-two factorial design to assign patients randomly to a standard or high dose of dialysis and to a low-flux or high-flux dialyzer. Results In the standard-dose group, the mean (±SD) urea-reduction ratio was 66.3±2.5 percent, the single-pool Kt/V was 1.32±0.09, and the equilibrated Kt/V was 1.16±0.08; in the high-dose group, the values were 75.2±2.5 percent, 1.71±0.11, and 1.53±0.09, respectively. Flux, estimated on the basis of beta2-microglobulin clearance, was 3±7 ml per minute in the low-flux group and 34±11 ml per minute in the high-flux group. The primary outcome, death from any cause, was not significantly influenced by the dose or flux assignment: the relative risk of death in the high-dose group as com...

1,670 citations


"Survival with Three-Times Weekly In..." refers background or methods in this paper

  • ...using two-sided t tests in two ways: (1) changes relative to the baseline...

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  • ...Among these patients, 435 (60%) contributed data to all three distinct time periods: (1) 90-day baseline on CHD before conversion to INHD, (2) during the first 90 days of INHD, and (3) during the period from 91 to 180 days on INHD....

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  • ...(1) We modified patient inclusion criteria as solely based on initial (i....

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Journal ArticleDOI
TL;DR: Frequent hemodialysis, as compared with conventional hemodIALysis, was associated with favorable results with respect to the composite outcomes of death or change in left ventricular mass and death orchange in a physical-health composite score but prompted more frequent interventions related to vascular access.
Abstract: Background In this randomized clinical trial, we aimed to determine whether increasing the frequency of in-center hemodialysis would result in beneficial changes in left ventricular mass, self-reported physical health, and other intermediate outcomes among patients undergoing maintenance hemodialysis. Methods Patients were randomly assigned to undergo hemodialysis six times per week (frequent hemodialysis, 125 patients) or three times per week (conventional hemodialysis, 120 patients) for 12 months. The two coprimary composite outcomes were death or change (from baseline to 12 months) in left ventricular mass, as assessed by cardiac magnetic resonance imaging, and death or change in the physical-health composite score of the RAND 36-item health survey. Secondary outcomes included cognitive performance; self-reported depression; laboratory markers of nutrition, mineral metabolism, and anemia; blood pressure; and rates of hospitalization and of interventions related to vascular access. Results Patients in the frequent-hemodialysis group averaged 5.2 sessions per week; the weekly standard Kt/V(urea) (the product of the urea clearance and the duration of the dialysis session normalized to the volume of distribution of urea) was significantly higher in the frequent-hemodialysis group than in the conventional-hemodialysis group (3.54±0.56 vs. 2.49±0.27). Frequent hemodialysis was associated with significant benefits with respect to both coprimary composite outcomes (hazard ratio for death or increase in left ventricular mass, 0.61; 95% confidence interval [CI], 0.46 to 0.82; hazard ratio for death or a decrease in the physical-health composite score, 0.70; 95% CI, 0.53 to 0.92). Patients randomly assigned to frequent hemodialysis were more likely to undergo interventions related to vascular access than were patients assigned to conventional hemodialysis (hazard ratio, 1.71; 95% CI, 1.08 to 2.73). Frequent hemodialysis was associated with improved control of hypertension and hyperphosphatemia. There were no significant effects of frequent hemodialysis on cognitive performance, self-reported depression, serum albumin concentration, or use of erythropoiesis-stimulating agents. Conclusions Frequent hemodialysis, as compared with conventional hemodialysis, was associated with favorable results with respect to the composite outcomes of death or change in left ventricular mass and death or change in a physical-health composite score but prompted more frequent interventions related to vascular access. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; ClinicalTrials.gov number, NCT00264758.).

878 citations


"Survival with Three-Times Weekly In..." refers background in this paper

  • ...Among these patients, 435 (60%) contributed data to all three distinct time periods: (1) 90-day baseline on CHD before conversion to INHD, (2) during the first 90 days of INHD, and (3) during the period from 91 to 180 days on INHD....

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Journal ArticleDOI
TL;DR: Associations between high serum parathyroid hormone and increased death risk were masked by case-mix characteristics of MHD patients, and Administration of any dose of paricalcitol was associated with improved survival in time-varying models.

866 citations

Journal ArticleDOI
TL;DR: Longer TT and higher Kt/V were independently as well as synergistically associated with lower mortality, and a randomized clinical trial of longer dialysis sessions in thrice-weekly HD is warranted.

490 citations

Journal ArticleDOI
TL;DR: Higher ultrafiltration rates in hemodialysis patients are associated with a greater risk of all-cause and cardiovascular death, and hospitalization for cardiovascular disease.

391 citations

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