Michael Copland

The effects of frequent nocturnal home hemodialysis: the Frequent Hemodialysis Network Nocturnal Trial

Prior small studies have shown multiple benefits of frequent nocturnal hemodialysis compared to conventional three times per week treatments. To study this further, we randomized 87 patients to three times per week conventional hemodialysis or to nocturnal hemodialysis six times per week, all with single-use high-flux dialyzers. The 45 patients in the frequent nocturnal arm had a 1.82-fold higher mean weekly stdKt/V(urea), a 1.74-fold higher average number of treatments per week, and a 2.45-fold higher average weekly treatment time than the 42 patients in the conventional arm. We did not find a significant effect of nocturnal hemodialysis for either of the two coprimary outcomes (death or left ventricular mass (measured by MRI) with a hazard ratio of 0.68, or of death or RAND Physical Health Composite with a hazard ratio of 0.91). Possible explanations for the left ventricular mass result include limited sample size and patient characteristics. Secondary outcomes included cognitive performance, self-reported depression, laboratory markers of nutrition, mineral metabolism and anemia, blood pressure and rates of hospitalization, and vascular access interventions. Patients in the nocturnal arm had improved control of hyperphosphatemia and hypertension, but no significant benefit among the other main secondary outcomes. There was a trend for increased vascular access events in the nocturnal arm. Thus, we were unable to demonstrate a definitive benefit of more frequent nocturnal hemodialysis for either coprimary outcome.

Intensive Hemodialysis Associates with Improved Survival Compared with Conventional Hemodialysis

Patients undergoing conventional maintenance hemodialysis typically receive three sessions per week, each lasting 2.5-5.5 hours. Recently, the use of more intensive hemodialysis (>5.5 hours, three to seven times per week) has increased, but the effects of these regimens on survival are uncertain. We conducted a retrospective cohort study to examine whether intensive hemodialysis associates with better survival than conventional hemodialysis. We identified 420 patients in the International Quotidian Dialysis Registry who received intensive home hemodialysis in France, the United States, and Canada between January 2000 and August 2010. We matched 338 of these patients to 1388 patients in the Dialysis Outcomes and Practice Patterns Study who received in-center conventional hemodialysis during the same time period by country, ESRD duration, and propensity score. The intensive hemodialysis group received a mean (SD) 4.8 (1.1) sessions per week with a mean treatment time of 7.4 (0.87) hours per session; the conventional group received three sessions per week with a mean treatment time of 3.9 (0.32) hours per session. During 3008 patient-years of follow-up, 45 (13%) of 338 patients receiving intensive hemodialysis died compared with 293 (21%) of 1388 patients receiving conventional hemodialysis (6.1 versus 10.5 deaths per 100 person-years; hazard ratio, 0.55 [95% confidence interval, 0.34-0.87]). The strength and direction of the observed association between intensive hemodialysis and improved survival were consistent across all prespecified subgroups and sensitivity analyses. In conclusion, there is a strong association between intensive home hemodialysis and improved survival, but whether this relationship is causal remains unknown.

Patient and Technique Survival among a Canadian Multicenter Nocturnal Home Hemodialysis Cohort

BACKGROUND AND OBJECTIVES As a result of improved clinical and quality-of-life outcomes compared with conventional hemodialysis, interest in nocturnal home hemodialysis (NHD) has steadily increased in the past decade; however, little is known about the flow of patients through NHD programs or about patient-specific predictors of mortality or technique failure associated with this modality. This study addressed this gap in knowledge. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS This study included 247 NHD patients of the Canadian Slow Long nightly ExtEnded dialysis Programs (CAN-SLEEP) cohort from 1994 through 2006 inclusive. The association between program- and patient-specific variables and risk for adverse outcomes was determined using uni- and multivariable Cox regression. RESULTS A total of 14.6% of the cohort experienced death or technique failure. Unadjusted 1- and 5-year adverse event-free survival was 95.2 and 80.1%, respectively. Significant predictors of a composite of mortality and technique failure included advanced age (P < 0.001), diabetes (P < 0.001), central venous catheter use (P = 0.01), and inability to perform NHD independently (P = 0.009) and were adjusted for center effect. Weekly frequency of NHD was not predictive. Age and diabetes remained significant with multivariable analysis (hazard ratio 1.07 and 2.64, respectively). Unadjusted 1- and 5-year technique survival was 97.9 and 95.2%, respectively. Only age was a significant predictor of technique failure. CONCLUSIONS NHD is associated with excellent adverse event-free survival. This study underscores the importance of modality-specific predictors in the success of home hemodialysis, as well as favorable baseline characteristics such as younger age and the absence of diabetes.

The cost of starting and maintaining a large home hemodialysis program

Home extended hours hemodialysis improves some measurable biological and quality-of-life parameters over conventional renal replacement therapies in patients with end-stage renal disease. Published small studies evaluating costs have shown savings in terms of ongoing operating costs with this modality. However, all estimates need to include the total costs, including infrastructure, patient training, and maintenance; patient attrition by death, transplantation, technique failure; and the necessity of in-center dialysis. We describe a comprehensive funding model for a large centrally administered but locally delivered home hemodialysis program in British Columbia, Canada that covered 122 patients, of which 113 were still in the program at study end. The majority of patients performed home nocturnal hemodialysis in this 2-year retrospective study. All training periods, both in-center and in-home dialysis, medications, hospitalizations, and deaths were captured using our provincial renal database and vital statistics. Comparative data from the provincial database and pricing models were used for costing purposes. The total comprehensive costs per patient-incorporating startup, home, and in-center dialysis; medications; home remodeling; and consumables-was

Intensive Hemodialysis, Mineral and Bone Disorder, and Phosphate Binder Use

59,179 for years 2004-2005 and

Intensive Hemodialysis and Potential Risks With Increasing Treatment

48,648 for 2005-2006. The home dialysis patients required multiple in-center dialysis runs, significantly contributing to the overall costs. Our study describes a valid, comprehensive funding model delineating reliable cost estimates of starting and maintaining a large home-based hemodialysis program. Consideration of hidden costs is important for administrators and planners to take into account when designing budgets for home hemodialysis.

Programmatic variation in home hemodialysis in Canada: results from a nationwide survey of practice patterns

Mineral and bone disorder is a common complication of end-stage renal disease. Notably, hyperphosphatemia likely promotes calcification of the myocardium, valves, and arteries. Hyperphosphatemia is associated with higher risk for cardiovascular mortality and morbidity along a gradient beginning at 5.0mg/dL. Among contemporary hemodialysis (HD) patients, mean serum phosphorus level is 5.2mg/dL, although 25% of patients have serum phosphorus levels of 5.5 to 6.9mg/dL; and 13%, >7.0mg/dL. Treatment of hyperphosphatemia is burdensome. Dialysis patients consume a mean of 19 pills per day, half of which are phosphate binders. Medicare Part D expenditures on binders for dialysis patients approached

Implementing a home haemodialysis programme without adversely affecting a peritoneal dialysis programme

700 million in 2013. Phosphorus removal with thrice-weekly HD (4 hours per session) is ∼3,000mg/wk. However, clearance is unlikely to counterbalance dietary intake, which varies around a mean of 7,000mg/wk. Dietary restriction and phosphate binders are important interventions, but each has limitations. Dietary control is complicated by limited access to healthy food choices and unclear labeling. Meanwhile, adherence to phosphate binders is poor, especially in younger patients and those with high pill burden. Multiple randomized clinical trials show that intensive HD reduces serum phosphorus levels. In the Frequent Hemodialysis Network (FHN) trial, short daily and nocturnal schedules reduced serum phosphorus levels by 0.6 and 1.6mg/dL, respectively, relative to 3 sessions per week. A similar effect of nocturnal HD was observed in an earlier trial. In the daily arm of the FHN trial, intensive HD significantly lowered estimated phosphate binder dose per day, whereas in the nocturnal arm, intensive HD led to binder discontinuation in 75% of patients. However, intensive HD appears to have no meaningful effects on serum calcium and parathyroid hormone concentrations. In conclusion, intensive HD, especially nocturnal HD, lowers serum phosphorus levels and decreases the need for phosphate binders.

Intensity of Continuous Renal Replacement Therapy in Acute Kidney Injury in the Intensive Care Unit: A Systematic Review and Meta-Analysis

Although intensive hemodialysis (HD) can address important clinical problems, increasing treatment also introduces risks. In this review, we assess risks pertaining to 6 domains: vascular access complications, infection, mortality, loss of residual kidney function, solute balance, and patient and care partner burden. In the Frequent Hemodialysis Network (FHN) trials, short daily and nocturnal schedules increased the incidence of access complications, although the incidence of access loss was not statistically higher. Observational studies indicate that infection-related hospitalization is an ongoing challenge with short daily HD. Excess risk may be catalyzed by poor infection control practices in the home setting in which intensive HD is typically delivered, but with fixed probability of bacterial contamination per cannulation, greater treatment frequency necessarily increases the risk for infectious complications. Buttonhole cannulation may increase the risk for metastatic infections. However, intensive HD in the home setting is associated with lower risk for infection than peritoneal dialysis. Data regarding mortality are equivocal. With extended follow-up of individuals in the FHN trials, short daily HD was associated with lower risk relative to the usual schedule, whereas nocturnal HD was associated with higher risk. In many, but not all, observational studies, short daily HD has been associated with lower risk than both in-center HD and peritoneal dialysis; however, observational studies are subject to unmeasured confounding. Intensive HD can accelerate the loss of residual kidney function in new dialysis patients with substantial urine output and can deplete solutes (eg, phosphorus) to the extent that supplementation is necessary. Finally, intensive HD may increase burden on patients and caregivers, possibly leading to technique failure. Some of these problems might be addressed with careful monitoring, so that relevant interventions (eg, antibiotics, retraining, and respite care) can be delivered. Ultimately, intensive HD is not a panacea for end-stage renal disease. Potential benefits and risks of treatment should be jointly considered.

Intensive Hemodialysis and Health-Related Quality of Life

BackgroundOver 40% of patients with end stage renal disease in the United States were treated with home hemodialysis (HHD) in the early 1970’s. However, this number declined rapidly over the ensuing decades so that the overwhelming majority of patients were treated in-centre 3 times per week on a 3-4 hour schedule. Poor outcomes for patients treated in this fashion led to a renewed interest in home hemodialysis, with more intensive dialysis schedules including short daily (SDHD) and nocturnal (NHD). The relative infancy of these treatment schedules means that there is a paucity of data on ‘how to do it’.ObjectiveWe undertook a systematic survey of home hemodialysis programs in Canada to describe current practice patterns.DesignDevelopment and deployment of a qualitative survey instrument.SettingCommunity and academic HHD programs in Canada.ParticipantsPhysicians, nurses and technologists.MeasurementsProgrammatic approaches to patient selection, delivery of dialysis, human resources available, and follow up.MethodsWe developed the survey instrument in three phases. A focus group of Canadian nephrologists with expertise in NHD or SDHD discussed the scope the study and wrote questions on 11 domains. Three nephrologists familiar with all aspects of HHD delivery reviewed this for content validity, followed by further feedback from the whole group. Multidisciplinary teams at three sites pretested the survey and further suggestions were incorporated. In July 2010 we distributed the survey electronically to all renal programs known to offer HHD according to the Canadian Organ Replacement Registry.We compiled the survey results using qualitative and quantitative methods, as appropriate.ResultsOf the academic and community programs that were invited to participate, 80% and 63%, respectively, completed the survey. We observed wide variation in programmatic approaches to patient recruitment, human resources, equipment, water, vascular access, patient training, dialysis prescription, home requirements, patient follow up, medications, and the approach to non-adherent patients.LimitationsCross-sectional survey, unable to link variation to outcomes. Competition for patients between HHD and home peritoneal dialysis means that case mix for HHD may also vary between centres.ConclusionsThere is wide variation between programs in all domains of HHD delivery in Canada. We plan further study of the extent to which differences in approach are related to outcomes.AbstractProblématiqueAu début des années 70, plus de 40% des patients en insuffisance rénale terminale aux États-Unis étaient traités par hémodialyse à domicile (HDD). Cette proportion a décliné rapidement au cours des décennies suivantes, de sorte que le mode de suppléance pour la majorité des patients est maintenant l’hémodialyse 3 fois par semaine à raison de 3 à 4 heures par séance. Les mauvais résultats obtenus avec cette méthode ont renouvelé l’intérêt pour l’HDD, notamment pour les dialyses intensives incluant la dialyse quotidienne courte (DQC) et l’hémodialyse nocturne (HDN). Étant donné leur nouveauté, il y a peu de données sur les façons de faire avec ces modes de suppléance.ObjectifAfin de décrire les pratiques actuelles, nous avons réalisé un questionnaire systématique auprès des programmes d’HDD au Canada.DesignDéveloppement et déploiement d’un outil qualitatif.CadreProgrammes d’HDD académiques et communautaires au CanadaParticipantsMédecins, infirmières et technologuesVariables mesuréesApproches pour la sélection des patients, le mode de suppléance, les ressources humaines disponibles et le mode de suivi pour chaque programmeMéthodologieNous avons développé un outil en trois phases. Un groupe de discussion composé de néphrologues canadiens ayant une expertise en DQC ou HDN ont échangé sur le contenu de l’étude et ont rédigé des questions sur 11 domaines. Trois néphrologues familiers avec tous les aspects de l’HDD ont révisé la validité des questions, puis ont demandé un nouvel avis à tout le groupe de discussion. Des équipes multidisciplinaires provenant de trois sites ont ensuite évalué le questionnaire et ont apporté des suggestions. En juillet 2010, le questionnaire a été distribué électroniquement à tous les programmes qui offrent l’HDD d’après le Registre canadien des insuffisances et des transplantations d’organes.Les résultats ont été compilés au moyen de méthodes qualitatives ou quantitatives, le cas échéant.Résultats80% des centres académiques et 63% des centres communautaires invités ont répondu au questionnaire. Nous avons observé des variations importantes entre les programmes quant au recrutement des patients, aux ressources humaines, à l’équipement, à l’eau, aux accès vasculaires, à l’entraînement des patients, à la prescription de dialyse, aux exigences du domicile, au suivi des patients, à la médication et à l’approche face aux patients non-adhérents.LimitationsÉtude transversale, incapacité d’associer les variations aux issues cliniques. La compétition entre l’HDD et la dialyse péritonéale pour le recrutement des patients entraîne peut-être une variabilité entre les centres dans la composition des groupes de patients en HDD.ConclusionsIl y a de grandes variations entre les programmes dans tous les domaines concernant l’HDD au Canada. Nous planifions d’étudier dans le futur jusqu’à quel point ces différences sont reliées aux issues cliniques.