Growing home dialysis: The Ontario Renal Network Home Dialysis Initiative 2012-2019.

The Ontario Renal Network (ORN), a provincial government agency in Ontario, Canada, launched an initiative in 2012 to increase home dialysis use province-wide. The initiative included a new modality-based funding formula, a standard mandatory informatics system, targets for prevalent home dialysis rates, the development of a 'network' of renal programmes with commitment to home dialysis and a culture of accountability with frequent meetings between ORN and each renal programme leadership to review their results. It also included funding of home dialysis coordinators, encouragement and funding of assisted peritoneal dialysis (PD), and support for catheter insertion and urgent start PD. Between 2012 and 2017, home dialysis use rose from 21.9% to 26.5% and then between 2017 and 2019 stabilised at 26% to 26.5%. Over 7 years, the absolute number of people on home dialysis increased 40% from 2222 to 3105, while the number on facility haemodialysis grew 11% from 7935 to 8767. PD prevalence rose from 16.6% to 20.9%, a relative increase of 25%. The initiative showed that a sustained multifaceted approach can increase home dialysis utilisation.

Cardiovascular Benefits of Extended-Time Nocturnal Hemodialysis.

Hemodialysis (HD) remains the most utilized treatment for End-Stage Kidney Disease (ESKD) globally, mainly as conventional HD administered in 4 h sessions thrice weekly. Despite advances in HD delivery, patients with ESKD carry a heavy cardiovascular morbidity and mortality burden. This is associated with cardiac remodeling, left ventricular hypertrophy (LVH), myocardial stunning, hypertension, decreased heart rate variability, sleep apnea, coronary calcification and endothelial dysfunction. Therefore, intensive HD regimens closer to renal physiology were developed. They include longer, more frequent dialysis or both. Among them, Nocturnal Hemodialysis (NHD), carried out at night while asleep, provides efficient dialysis without excessive interference with daily activities. This regimen is closer to the physiology of the native kidneys. By providing increased clearance of small and middle molecular weight molecules, NHD can ameliorate uremic symptoms, control hyperphosphatemia and improve quality of life by allowing a liberal diet and free time during the day. Lastly, it improves reproductive biology leading to successful pregnancies. Conversion from conventional to NHD is followed by improved blood pressure control with fewer medications, regression of LVH, improved LV function, improved sleep apnea, and stabilization of coronary calcifications. These beneficial effects have been associated, among others, with better extracellular fluid volume control, improved endothelial- dependent vasodilation, decreased total peripheral resistance, decreased plasma norepinephrine levels and restoration of heart rate variability. Some of these effects represent improvements in outcomes used as surrogates of hard outcomes related to cardiovascular morbidity and mortality. In this review, we consider the cardiovascular effects of NHD.

Technique Failure in a Multicenter Canadian Home Hemodialysis Cohort.

RATIONALE & OBJECTIVE: Increasing uptake of home hemodialysis (HD) has led to interest in characteristics that predict discontinuation of home HD therapy for reasons other than death or transplantation. Recent reports of practice pattern variability led to the hypothesis that there are patient- and center-specific factors that influence these discontinuations. STUDY DESIGN: Retrospective cohort study. SETTING & PARTICIPANTS: Incident home HD patients at 7 centers in Canada between 2000 and 2010. PREDICTOR: Treatment center, case-mix, and process-of-care variables. OUTCOMES: Technique failure (defined as discontinuation of home HD therapy for any reason other than training failure, death, or transplantation) and mortality. ANALYTICAL APPROACH: Regression modeling of technique failure using Cox proportional hazard models adjusting for treatment center and modifiable and nonmodifiable patient-level variables, censored for death and transplantation. RESULTS: The cohort consisted of 579 patients. Mean age was 49.9±14.1 years, 74% were of European ancestry, median dialysis vintage was 1.9 (IQR, 0.6-5.2) years, and 68% used an arteriovenous access. Mean duration of dialysis was 31.2±12.6 hours per week. Unadjusted 1- and 2-year technique survival and overall survival were 90% and 83% and 94% and 87%, respectively. Treating center was a strong predictor of technique failure and mortality, with HRs ranging from 0.37 to 5.11 for technique failure (1 of 6 centers with P<0.05 relative to the reference) and 0.17 to 8.73 for mortality (3 of 6 centers with P<0.05 relative to the reference). With baseline adjustment for center, only older age and more than 3 treatments per week remained significant predictors of technique failure, while no individual-level variables remained as significant predictors of survival. LIMITATIONS: Limited statistical power. CONCLUSIONS: Home HD treating centers may influence technique failure and patient mortality independent of case-mix. The relationship between processes of care and patient outcomes requires further investigation.

Patients receiving frequent hemodialysis have better health-related quality of life compared to patients receiving conventional hemodialysis.

Most patients with end-stage kidney disease value their health-related quality of life (HRQoL) and want to know how it will be affected by their dialysis modality. We extended the findings of two prior clinical trial reports to estimate the effects of frequent compared to conventional hemodialysis on additional measures of HRQoL. The Daily Trial randomly assigned 245 patients to receive frequent (six times per week) or conventional (three times per week) in-center hemodialysis. The Nocturnal Trial randomly assigned 87 patients to receive frequent nocturnal (six times per week) or conventional (three times per week) home hemodialysis. All patients were on conventional hemodialysis prior to randomization, with an average feeling thermometer score of 70 to 75 (a visual analog scale from 0 to 100 where 100 is perfect health), an average general health scale score of 40 to 47 (a score from 0 to 100 where 100 is perfect health), and an average dialysis session recovery time of 2 to 3 hours. Outcomes are reported as the between-treatment group differences in one-year change in HRQoL measures and analyzed using linear mixed effects models. After one year in the Daily Trial, patients assigned to frequent in-center hemodialysis reported a higher feeling thermometer score, better general health, and a shorter recovery time after a dialysis session compared to standard thrice-weekly dialysis. After one year in the Nocturnal Trial, patients assigned to frequent home hemodialysis also reported a shorter recovery time after a dialysis session, but no statistical difference in their feeling thermometer or general health scores compared to standard home dialysis schedules. Thus, patients receiving day or nocturnal hemodialysis on average recovered approximately one hour earlier from a frequent compared to conventional hemodialysis session. Patients treated in an in-center dialysis facility reported better HRQoL with frequent compared to conventional hemodialysis.

Personal Support Worker (PSW)-supported home hemodialysis: A paradigm shift.

INTRODUCTION: Despite improving clinical outcomes associated with the use of home hemodialysis (HD), its utilization is low in most countries. The inability or unwillingness of patients and their families to participate in their own treatment is one of the most important barriers to the adoption of home HD. METHODS: We hypothesized that paid helper-delivered home HD supported by public funds would be successful and welcomed by patients and be delivered at an affordable cost. We conducted a pilot project to dialyze six patients at home using Personal Support Workers (PSW) and resolve regulatory, organizational and financial constraints. FINDINGS: cWe provided publically-funded PSW-supported home HD to six patients. We describe the administrative structure of the pilot project allowing scalability and turnkey operation in the province of Ontario. Regulatory and insurance concerns were resolved and patients and staff were enthusiastic. The projected total dialysis cost, when economies of scale are met, are expected to be lower than the cost of in-center HD. DISCUSSION: A second phase of the project is currently under way including 8 hospitals and 67 patients. If equally successful, it may have significant implications for the delivery of care for End Stage Renal Disease in Ontario and similar jurisdictions. It promises to increase the utilization of home dialysis possibly at a lower cost than in-center HD. This would be particularly important in providing dialysis in underserviced and geographically hard to access areas.

Non-Linear Heart Rate Variability Indices in the Frequent Hemodialysis Network Trials of Chronic Hemodialysis Patients.

BACKGROUND: Non-linear heart rate variability (HRV) indices were hypothesized to correlate with cardiac function, fluid overload and physical performance in hemodialysis patients. METHODS: Twenty-four-hour Holter electrocardiograms were recorded in patients enrolled in the Frequent Hemodialysis Network (FHN) Daily Dialysis Trial. Correlations between non-linear HRV indices and left ventricular ejection fraction (LVEF), left ventricular end-diastolic volume (LVEDV), extracellular volume (ECV)/total body water (TBW) ratio, the SF-36 Physical Health Composite (PHC) and Physical Functioning (PF) scores were tested. RESULTS: We studied 210 subjects (average age 49.8 ± 13.5 years, 62% men, 42% diabetics). In non-diabetic patients, multiscale entropy (MSE) slope sample entropy (SampEn) and approximate entropy (ApEn) correlated positively with LVEF, PF and PHC and inversely with LVEDV and ECV/TBW. Spectral power slope correlated positively with ECV/TBW (r = 0.27). Irregularity measures (MSE ApEn and MSE SampEn) correlated positively with LVEDV (r = 0.19 and 0.20). CONCLUSION: Non-linear HRV indices indicated an association between a deteriorated heart rate regulatory system and impaired cardiac function, fluid accumulation and poor physical condition.

Long-term Effects of Frequent Nocturnal Hemodialysis on Mortality: The Frequent Hemodialysis Network (FHN) Nocturnal Trial.

BACKGROUND: Few data are available regarding the long-term mortality rate for patients receiving nocturnal home hemodialysis. STUDY DESIGN: Posttrial observational study. SETTING & PARTICIPANTS: Frequent Hemodialysis Network (FHN) Nocturnal Trial participants who consented to extended follow-up. INTERVENTION: The FHN Nocturnal Trial randomly assigned 87 individuals to 6-times-weekly home nocturnal hemodialysis or 3-times-weekly hemodialysis for 1 year. Patients were enrolled starting in March 2006 and follow-up was completed by May 2010. After the 1-year trial concluded, FHN Nocturnal participants were free to modify their hemodialysis prescription. OUTCOMES & MEASUREMENTS: We obtained dates of death and kidney transplantation through July 2011 using linkage to the US Renal Data System and queries of study centers. We used log-rank tests and Cox regression to relate mortality to the initial randomization assignment. RESULTS: Median follow-up for the trial and posttrial observational period was 3.7 years. In the nocturnal arm, there were 2 deaths during the 12-month trial period and an additional 12 deaths during the extended follow-up. In the conventional arm, the numbers of deaths were 1 and 4, respectively. In the nocturnal dialysis group, the overall mortality HR was 3.88 (95% CI, 1.27-11.79; P=0.01). Using as-treated analysis with a 12-month running treatment average, the HR for mortality was 3.06 (95% CI, 1.11-8.43; P=0.03). Six-month running treatment data analysis showed an HR of 1.12 (95% CI, 0.44-3.22; P=0.7). LIMITATIONS: 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 hemodialysis prescription changes. CONCLUSIONS: Patients randomly assigned to nocturnal hemodialysis had a higher mortality rate than those randomly assigned to conventional dialysis. The implications of this result require further investigation.

Effects of frequent hemodialysis on blood pressure: Results from the randomized frequent hemodialysis network trials.

Hypertension is a common complication of chronic kidney disease and persists among most patients with end-stage renal disease despite the provision of conventional thrice weekly hemodialysis (HD). We analyzed the effects of frequent HD on blood pressure in the randomized controlled Frequent Hemodialysis Network trials. The daily trial randomized 245 patients to 12 months of 6× ("frequent") vs. 3× ("conventional") weekly in-center hemodialysis; the nocturnal trial randomized 87 patients to 12 months of 6× weekly nocturnal HD vs. 3× weekly predominantly home-based hemodialysis. In the daily trial, compared with 3× weekly HD, 2 months of frequent HD lowered predialysis systolic blood pressure by -7.7 mmHg [95% confidence interval (CI): -11.9 to -3.5] and diastolic blood pressure by -3.9 mmHg [95% CI: -6.5 to -1.3]. In the nocturnal trial, compared with 3× weekly HD, 2 months of frequent HD lowered systolic blood pressure by -7.3 mmHg [95% CI: -14.2 to -0.3] and diastolic blood pressure by -4.2 mmHg [95% CI: -8.3 to -0.1]. In both trials, blood pressure treatment effects were sustained until month 12. Frequent HD resulted in significantly fewer antihypertensive medications (daily: -0.36 medications [95% CI: -0.65 to -0.08]; nocturnal: -0.44 mediations [95% CI: -0.89 to -0.03]). In the daily trial, the relative risk per dialysis session for intradialytic hypotension was lower with 6×/week HD but given the higher number of sessions per week, there was a higher relative risk for intradialytic hypotensive requiring saline administration. In summary, frequent HD reduces blood pressure and the number of prescribed antihypertensive medications.

Delivering home hemodialysis: is there still a role for real-time treatment monitoring?

Remote real-time treatment monitoring for home hemodialysis (HHD) was driven by concerns over patient safety in the early era of HHD. However, decades of clinical experience supported by objective data suggest that HHD is very safe and that remote monitoring is unlikely to avert serious adverse events. As a result, such remote monitoring is not routinely offered in the current era and is generally considered an unnecessary expense. However, a one-size-fits-all approach to abandon remote monitoring may overlook potential opportunities: to improve the clinical care of patients dialyzing at home; and to give patients the confidence to perform HHD in an unsupervised setting.

Peritoneal dialysis catheter implantation by nephrologists is associated with higher rates of peritoneal dialysis utilization: a population-based study.

BACKGROUND: The likelihood of peritoneal dialysis (PD) utilization following a PD catheter insertion attempt is poorly described. We explored the risk factors for PD nonuse, focusing on the method of PD catheter implantation. METHODS: This population-based retrospective cohort study employed Ontario administrative health data to identify 3886 predialysis adults who had an incident PD catheter implantation between 2002 and 2010. The impact of the method of catheter implantation including open-surgical (open, n = 1884), surgical-laparoscopic (laparoscopic, n = 1154), nephrology-percutaneous (nephrology, n = 498) and radiology-percutaneous (radiology, n = 350) on rates of PD utilization (defined as four consecutive weeks of PD) was examined. RESULTS: Eighty-three percent of study patients received PD. After adjustment, relative to patients with openly inserted catheters, PD utilization was greater for those with nephrology-inserted catheters [adjusted hazard ratio (aHR) 1.59, 95% confidence interval (CI) 1.29-1.95] and similar for radiology-inserted catheters [aHR 1.16, 95% CI 0.94-1.43] or laparoscopic-inserted catheters [aHR 0.97 (95% CI 0.86-1.09)]. Among PD nonusers, death occurred in 10% of the open group, 6% of the laparoscopic group, 27% of the radiology group and in fewer than 3% of the nephrology group. Sixty-nine percent received hemodialysis in the open group, 63% in the laparoscopic group, 61% in the radiology group and 88% in the nephrology group. Those remaining predialysis comprised 12% of the open group, 22% of the laparoscopic group, 11% of the radiology group and <3% of the nephrology group. CONCLUSIONS: Nephrology insertion resulted in lower overall rates of PD nonuse, particularly due to death or remaining predialysis. Greater use may be related to insertion timing, technique or greater commitment on the part of nephrologists to the success of PD.

Intensive hemodialysis associates with improved pregnancy outcomes: a Canadian and United States cohort comparison.

Pregnancy is rare in women with ESRD and when it occurs, it is often accompanied by significant maternal and fetal morbidity and even mortality. Preliminary data from the Toronto Nocturnal Hemodialysis Program suggested that increased clearance of uremic toxins by intensified hemodialysis improves pregnancy outcomes, but small numbers and the absence of a comparator group limited widespread applicability of these findings. We compared pregnancy outcomes from 22 pregnancies in the Toronto Pregnancy and Kidney Disease Clinic and Registry (2000-2013) with outcomes from 70 pregnancies in the American Registry for Pregnancy in Dialysis Patients (1990-2011). The primary outcome was the live birth rate and secondary outcomes included gestational age and birth weight. The live birth rate in the Canadian cohort (86.4%) was significantly higher than the rate in the American cohort (61.4%; P=0.03). Among patients with established ESRD, the median duration of pregnancy in the more intensively dialyzed Toronto cohort was 36 weeks (interquartile range, 32-37) compared with 27 weeks (interquartile range, 21-35) in the American cohort (P=0.002). Furthermore, a dose response between dialysis intensity and pregnancy outcomes emerged, with live birth rates of 48% in women dialyzed ≤20 hours per week and 85% in women dialyzed >36 hours per week (P=0.02), with a longer gestational age and greater infant birth weight for women dialyzed more intensively. Pregnancy complications were few and manageable. We conclude that pregnancy may be safe and feasible in women with ESRD receiving intensive hemodialysis.

Effects of daily hemodialysis on heart rate variability: results from the Frequent Hemodialysis Network (FHN) Daily Trial.

BACKGROUND: End-stage renal disease is associated with reduced heart rate variability (HRV), components of which generally are associated with advanced age, diabetes mellitus and left ventricular hypertrophy. We hypothesized that daily in-center hemodialysis (HD) would increase HRV. METHODS: The Frequent Hemodialysis Network (FHN) Daily Trial randomized 245 patients to receive 12 months of six versus three times per week in-center HD. Two hundred and seven patients had baseline Holter recordings. HRV measures were calculated from 24-h Holter electrocardiograms at both baseline and 12 months in 131 patients and included low-frequency power (LF, a measure of sympathetic modulation), high-frequency power (HF, a measure of parasympathetic modulation) and standard deviation (SD) of the R-R interval (SDNN, a measure of beat-to-beat variation). RESULTS: Baseline to Month 12 change in LF was augmented by 50% [95% confidence interval (95% CI) 6.1-112%, P =0.022] and LF + HF was augmented by 40% (95% CI 3.3-88.4%, P = 0.03) in patients assigned to daily hemodialysis (DHD) compared with conventional HD. Changes in HF and SDNN were similar between the randomized groups. The effects of DHD on LF were attenuated by advanced age and diabetes mellitus (predefined subgroups). Changes in HF (r = -0.20, P = 0.02) and SDNN (r = -0.18, P = 0.04) were inversely associated with changes in left ventricular mass (LVM). CONCLUSIONS: DHD increased the LF component of HRV. Reduction of LVM by DHD was associated with increased vagal modulation of heart rate (HF) and with increased beat-to-beat heart rate variation (SDNN), suggesting an important functional correlate to the structural effects of DHD on the heart in uremia.

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

BACKGROUND: Over 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'. OBJECTIVE: We undertook a systematic survey of home hemodialysis programs in Canada to describe current practice patterns. DESIGN: Development and deployment of a qualitative survey instrument. SETTING: Community and academic HHD programs in Canada. PARTICIPANTS: Physicians, nurses and technologists. MEASUREMENTS: Programmatic approaches to patient selection, delivery of dialysis, human resources available, and follow up. METHODS: We 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. RESULTS: Of 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. LIMITATIONS: Cross-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. CONCLUSIONS: There 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.

PROBLÉMATIQUE: Au 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. OBJECTIF: Afin de décrire les pratiques actuelles, nous avons réalisé un questionnaire systématique auprès des programmes d'HDD au Canada. DESIGN: Développement et déploiement d'un outil qualitatif. CADRE: Programmes d'HDD académiques et communautaires au Canada. PARTICIPANTS: Médecins, infirmières et technologues. VARIABLES MESURÉES: Approches pour la sélection des patients, le mode de suppléance, les ressources humaines disponibles et le mode de suivi pour chaque programme. MÉTHODOLOGIE: Nous 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. RÉSULTATS: 80% 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. LIMITATIONS: Étude 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. CONCLUSIONS: Il 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.

A systematic review of buttonhole cannulation practices and outcomes.

Buttonhole (constant site) cannulation has emerged as an attractive technique for needling arteriovenous fistulae. However, the balance of benefits and harms associated with this intervention is unclear. We conducted a systematic review of studies reporting outcomes with buttonhole cannulation. The setting and population included adult patients receiving home or center hemodialysis. We searched MEDLINE, Embase (1980-June 2012), and CINAHL (1997-June 2012), for randomized and observational studies. We also searched conference proceedings (2009-2011). The interventions included: 1) buttonhole cannulation established by sharp needles, with or without a polycarbonate peg, 2) rope-ladder cannulation. Outcomes of interest included: Facility practices, systemic infection, local infection, access survival, access interventions, access-related hospitalization, patient survival, pain, quality of life, and aneurysm formation. We identified 23 full-text articles and 4 abstracts; 3 were open-label trials, and the remainder observational studies of varying design and methodological quality. Studies were predominantly descriptive and lacked direct comparisons between buttonhole and rope-ladder cannulation. No qualitative differences in outcomes were noted among home and center hemodialysis patients using buttonhole cannulation. Rates of bacteremia were generally higher with buttonhole cannulation. Studies reporting access survival, hospitalization, quality of life, pain, and aneurysm formation had serious methodological limitations that limited our confidence in their estimates of effect. Among the various facility practices that were described, only the application of mupirocin cream was noted to be associated with reduced risk of infection. Limitations in included studies were short follow-up, crossover designs, lack of parallel control groups, and the use of patient-reported outcome measures that were not well validated. The main limitation of this review was a limited literature search. Buttonhole cannulation may be associated with an increased risk of infection. Larger, more definitive studies are needed to determine whether this technique is safe for broader use.

Vascular access for intensive maintenance hemodialysis: a systematic review for a Canadian Society of Nephrology clinical practice guideline.

BACKGROUND: Practices in vascular access management with intensive hemodialysis may differ from those used in conventional hemodialysis. STUDY DESIGN: We conducted a systematic review to inform clinical practice guidelines for the provision of intensive hemodialysis. SETTING & POPULATION: Adult patients receiving maintenance (>3 months) intensive hemodialysis (frequent [≥5 hemodialysis treatments per week] and/or long [>5.5 hours per hemodialysis treatment]). SELECTION CRITERIA FOR STUDIES: We searched EMBASE and MEDLINE (1990-2011) for randomized and observational studies. We also searched conference proceedings (2007-2011). INTERVENTIONS: (1) Central venous catheter (CVC) versus arteriovenous (AV) access, (2) buttonhole versus rope-ladder cannulation, (3) topical antimicrobial cream versus none in buttonhole cannulation, and (4) closed connector devices among CVC users. OUTCOMES: Access-related infection, survival, hospitalization, patency, access survival, intervention rates, and quality of life. RESULTS: We included 23, 7, and 5 reports describing effectiveness by access type, buttonhole cannulation, and closed connector device, respectively. No study directly compared CVC with AV access. On average, bacteremia and local infection rates were higher with CVC compared with AV access. Access intervention rates were higher with more frequent hemodialysis, but access survival did not differ. Buttonhole cannulation was associated with bacteremia rates similar to those seen with CVCs in some series. Topical mupirocin seemed to attenuate this effect. No direct comparisons of closed connector devices versus standard luer-locking devices were found. Low rates of actual or averted (near misses) air embolism and bleeding were reported with closed connector devices. LIMITATIONS: Overall, evidence quality was very low. Limited direct comparisons addressing main review questions, small sample sizes, selective outcome reporting, publication bias, and residual confounding were major factors. CONCLUSIONS: This review highlights several differences in the management of vascular access in conventional and intensive hemodialysis populations. We identify a need for standardization of vascular access outcome reporting and a number of priorities for future research.

Canadian Society of Nephrology guidelines for the management of patients with ESRD treated with intensive hemodialysis.

Intensive (longer and more frequent) hemodialysis has emerged as an alternative to conventional hemodialysis for the treatment of patients with end-stage renal disease. However, given the differences in dialysis delivery and models of care associated with intensive dialysis, alternative approaches to patient management may be required. The purpose of this work was to develop a clinical practice guideline for the Canadian Society of Nephrology. We applied the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach for guideline development and performed targeted systematic reviews and meta-analysis (when appropriate) to address prioritized clinical management questions. We included studies addressing the treatment of patients with end-stage renal disease with short daily (≥5 days per week, <3 hours per session), long (3-4 days per week, ≥5.5 hours per session), or long-frequent (≥5 days per week, ≥5.5 hours per session) hemodialysis. We included clinical trials and observational studies with or without a control arm (1990 and later). Based on a prioritization exercise, 6 interventions of interest included optimal vascular access type, buttonhole cannulation, antimicrobial prophylaxis for buttonhole cannulation, closed connector devices, and dialysate calcium and dialysate phosphate additives for patients receiving intensive hemodialysis. We developed 6 recommendations addressing the interventions of interest. Overall quality of the evidence was very low and all recommendations were conditional. We provide detailed commentaries to guide in shared decision making. The main limitation was the very low overall quality of evidence that precluded strong recommendations. Most included studies were small single-arm observational studies. Three randomized controlled trials were applicable, but provided only indirect evidence. Published information for patient values and preference was lacking. In conclusion, we provide 6 recommendations for the practice of intensive hemodialysis. However, due to very low-quality evidence, all recommendations were conditional. We therefore also highlight priorities for future research.

Dialysate calcium concentration and mineral metabolism in long and long-frequent hemodialysis: a systematic review and meta-analysis for a Canadian Society of Nephrology clinical practice guideline.

BACKGROUND: Patients treated with conventional hemodialysis (HD) develop disorders of mineral metabolism that are associated with increased morbidity and mortality. More frequent and longer HD has been associated with improvement in hyperphosphatemia that may improve outcomes. STUDY DESIGN: Systematic review and meta-analysis to inform the clinical practice guideline on intensive dialysis for the Canadian Society of Nephrology. SETTING & POPULATION: Adult patients receiving outpatient long (≥5.5 hours/session; 3-4 times per week) or long-frequent (≥5.5 hours/session, ≥5 sessions per week) HD. SELECTION CRITERIA FOR STUDIES: We included clinical trials, cohort studies, case series, case reports, and systematic reviews. INTERVENTIONS: Dialysate calcium concentration ≥1.5 mmol/L and/or phosphate additive. OUTCOMES: Fragility fracture, peripheral arterial and coronary artery disease, calcific uremic arteriolopathy, mortality, intradialytic hypotension, parathyroidectomy, extraosseous calcification, markers of mineral metabolism, diet liberalization, phosphate-binder use, and muscle mass. RESULTS: 21 studies were identified: 2 randomized controlled trials, 2 reanalyses of data from the randomized controlled trials, and 17 observational studies. Dialysate calcium concentration ≥1.5 mmol/L for patients treated with long and long-frequent HD prevents an increase in parathyroid hormone levels and a decline in bone mineral density without causing harm. Both long and long-frequent HD were associated with a reduction in serum phosphate level of 0.42-0.45 mmol/L and a reduction in phosphate-binder use. There was no direct evidence to support the use of a dialysate phosphate additive. LIMITATIONS: Almost all the available information is related to changes in laboratory values and surrogate outcomes. CONCLUSIONS: Dialysate calcium concentration ≥1.5 mmol/L for most patients treated with long and long-frequent dialysis prevents an increase in parathyroid hormone levels and decline in bone mineral density without increased risk of calcification. It seems prudent to add phosphate to the dialysate for patients with a low predialysis phosphate level or very low postdialysis phosphate level until more evidence becomes available.

Effects of frequent hemodialysis on measures of CKD mineral and bone disorder.

More frequent hemodialysis sessions and longer session lengths may offer improved phosphorus control. We analyzed data from the Frequent Hemodialysis Network Daily and Nocturnal Trials to examine the effects of treatment assignment on predialysis serum phosphorus and on prescribed dose of phosphorus binder, expressed relative to calcium carbonate on a weight basis. In the Daily Trial, with prescribed session lengths of 1.5-2.75 hours six times per week, assignment to frequent hemodialysis associated with both a 0.46 mg/dl decrease (95% confidence interval [95% CI], 0.13-0.78 mg/dl) in mean serum phosphorus and a 1.35 g/d reduction (95% CI, 0.20-2.50 g/d) in equivalent phosphorus binder dose at month 12 compared with assignment to conventional hemodialysis. In the Nocturnal Trial, with prescribed session lengths of 6-8 hours six times per week, assignment to frequent hemodialysis associated with a 1.24 mg/dl decrease (95% CI, 0.68-1.79 mg/dl) in mean serum phosphorus compared with assignment to conventional hemodialysis. Among patients assigned to the group receiving six sessions per week, 73% did not require phosphorus binders at month 12 compared with only 8% of patients assigned to sessions three times per week (P<0.001). At month 12, 42% of patients on nocturnal hemodialysis required the addition of phosphorus into the dialysate to prevent hypophosphatemia. Frequent hemodialysis did not have major effects on calcium or parathyroid hormone concentrations in either trial. In conclusion, frequent hemodialysis facilitates control of hyperphosphatemia and extended session lengths could allow more liberal diets and freedom from phosphorus binders.

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.