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The current and future landscape of dialysis
by
Mehrotra Rajnish
,
Vanholder Raymond
,
Tonelli Marcello
in
Epidemiology
,
Hemodialysis
,
Innovations
2020
The development of dialysis by early pioneers such as Willem Kolff and Belding Scribner set in motion several dramatic changes in the epidemiology, economics and ethical frameworks for the treatment of kidney failure. However, despite a rapid expansion in the provision of dialysis — particularly haemodialysis and most notably in high-income countries (HICs) — the rate of true patient-centred innovation has slowed. Current trends are particularly concerning from a global perspective: current costs are not sustainable, even for HICs, and globally, most people who develop kidney failure forego treatment, resulting in millions of deaths every year. Thus, there is an urgent need to develop new approaches and dialysis modalities that are cost-effective, accessible and offer improved patient outcomes. Nephrology researchers are increasingly engaging with patients to determine their priorities for meaningful outcomes that should be used to measure progress. The overarching message from this engagement is that while patients value longevity, reducing symptom burden and achieving maximal functional and social rehabilitation are prioritized more highly. In response, patients, payors, regulators and health-care systems are increasingly demanding improved value, which can only come about through true patient-centred innovation that supports high-quality, high-value care. Substantial efforts are now underway to support requisite transformative changes. These efforts need to be catalysed, promoted and fostered through international collaboration and harmonization.Dialysis is a life-saving therapy; however, costs of dialysis are high, access is inequitable and outcomes are inadequate. This Review describes the current landscape of dialysis therapy from an epidemiological, economic, ethical and patient-centred framework, and describes initiatives that are aimed at stimulating innovations in the field to one that supports high-quality, high-value care.
Journal Article
A clinical study of efficacy and safety of the Carry Life UF system in continuous ambulatory peritoneal dialysis patients: protocol for a prospective, multicenter, randomized, crossover study
2025
Background
Carry Life UF is a novel peritoneal dialysis (PD) technology for improved fluid management using steady concentration PD (SCPD). The Carry Life UF treatment starts with a manual peritoneal fill of 1.36% glucose PD fluid, followed by a 5-hour treatment where small amounts of glucose are continuously added to maintain a stable intraperitoneal glucose concentration. A recent in-center clinical study using the Carry Life UF system demonstrated higher ultrafiltration (UF) rates, more efficient use of glucose (increased UF volume/gram of glucose absorbed), and greater sodium removal with the Carry Life UF treatments compared with a 2.27% glucose continuous ambulatory PD (CAPD) dwell. The aim of this study is to compare efficacy and safety of the Carry Life UF system with a standard CAPD prescription in the home setting.
Methods
A prospective, multicenter, randomized, crossover study of 19 adult subjects at up to 12 sites in Italy, Sweden and the UK will complete the investigation. End-stage kidney disease patients with a CAPD prescription of 2–4 exchanges per day, including at least one 2.27% glucose dwell, will be included. After a Carry Life UF glucose dose determination phase performed in-clinic, subjects will be randomized to start the home treatment part of the study with either the control arm (2.27% glucose CAPD dwell) or the Carry Life UF arm (11 or 15 g/h glucose dose), each for four weeks. The primary endpoint is UF volume comparing the control CAPD 2.27% glucose dwell with the Carry Life UF treatment. Secondary endpoints include adverse event rates, peritoneal sodium removal, glucose UF efficiency, and peak dialysate glucose concentration.
Discussion
This study will evaluate a novel PD technology in the home environment. Challenging aspects include the need to accurately measure UF volumes at home and to support subjects in using a novel technology. The study design considers important parameters for precise UF volume measurements and provides detailed weighing instructions to the study team to ensure consistency between study centers. Research nursing support will be provided for training of subjects and to support endpoint data collection in the subjects’ home. Due to the significant burden associated with the study, subjects will be offered a fair compensation, in accordance with local regulations.
Trial registration
ClinicalTrials.gov Identifier: NCT05874804 Registration date: 18th of April 2023.
Journal Article
Dialysis modalities for the management of pediatric acute kidney injury
2020
Acute kidney injury (AKI) is an increasingly frequent complication among hospitalized children. It is associated with high morbidity and mortality, especially in neonates and children requiring dialysis. The different renal replacement therapy (RRT) options for AKI have expanded from peritoneal dialysis (PD) and intermittent hemodialysis (HD) to continuous RRT (CRRT) and hybrid modalities. Recent advances in the provision of RRT in children allow a higher standard of care for increasingly ill and young patients. In the absence of evidence indicating better survival with any dialysis method, the most appropriate dialysis choice for children with AKI is based on the patient’s characteristics, on dialytic modality performance, and on the institutional resources and local practice. In this review, the available dialysis modalities for pediatric AKI will be discussed, focusing on indications, advantages, and limitations of each of them.
Journal Article
Personalised cooler dialysate for patients receiving maintenance haemodialysis (MyTEMP): a pragmatic, cluster-randomised trial
by
Chambers, Laura C
,
Chan, Patricia CK
,
Gregor, Laura H
in
Bias
,
Blood pressure
,
Body temperature
2022
Haemodialysis centres have conventionally provided maintenance haemodialysis using a standard dialysate temperature (eg, 36·5°C) for all patients. Many centres now use cooler dialysate (eg, 36·0°C or lower) for potential cardiovascular benefits. We aimed to assess whether personalised cooler dialysate, implemented as centre-wide policy, reduced the risk of cardiovascular-related death or hospital admission compared with standard temperature dialysate.
MyTEMP was a pragmatic, two-arm, parallel-group, registry-based, open-label, cluster-randomised, superiority trial done at haemodialysis centres in Ontario, Canada. Eligible centres provided maintenance haemodialysis to at least 15 patients a week, and the medical director of each centre had to confirm that their centre would deliver the assigned intervention. Using covariate-constrained randomisation, we allocated 84 centres (1:1) to use either personalised cooler dialysate (nurses set the dialysate temperature 0·5–0·9°C below each patient's measured pre-dialysis body temperature, with a lowest recommended dialysate temperature of 35·5°C), or standard temperature dialysate (36·5°C for all patients and treatments). Patients and health-care providers were not masked to the group assignment; however, the primary outcome was recorded in provincial databases by medical coders who were unaware of the trial or the centres’ group assignment. The primary composite outcome was cardiovascular-related death or hospital admission with myocardial infarction, ischaemic stroke, or congestive heart failure during the 4-year trial period. Analysis was by intention to treat. The study is registered at ClinicalTrials.gov, NCT02628366.
We assessed all of Ontario's 97 centres for inclusion into the study. Nine centres had less than 15 patients and one director requested that four of their seven centres not participate. 84 centres were recruited and on Feb 1, 2017, these centres were randomly assigned to administer personalised cooler dialysate (42 centres) or standard temperature dialysate (42 centres). The intervention period was from April 3, 2017, to March 31, 2021, and during this time the trial centres provided outpatient maintenance haemodialysis to 15 413 patients (about 4·3 million haemodialysis treatments). The mean dialysate temperature was 35·8°C in the cooler dialysate group and 36·4°C in the standard temperature group. The primary outcome occurred in 1711 (21·4%) of 8000 patients in the cooler dialysate group versus 1658 (22·4%) of 7413 patients in the standard temperature group (adjusted hazard ratio 1·00, 96% CI 0·89 to 1·11; p=0·93). The mean drop in intradialytic systolic blood pressure was 26·6 mm Hg in the cooler dialysate group and 27·1 mm Hg in the standard temperature group (mean difference –0·5 mm Hg, 99% CI –1·4 to 0·4; p=0·14).
Centre-wide delivery of personalised cooler dialysate did not significantly reduce the risk of major cardiovascular events compared with standard temperature dialysate. The rising popularity of cooler dialysate is called into question by this study, and the risks and benefits of cooler dialysate in some patient populations should be clarified in future trials.
Canadian Institutes of Health Research, Heart and Stroke Foundation of Canada, Ontario Renal Network, Ontario Strategy for Patient-Oriented Research Support Unit, Dialysis Clinic, Inc., ICES (formerly known as the Institute for Clinical Evaluative Sciences), Lawson Health Research Institute, and Western University.
Journal Article
Long-term follow-up of patients randomized to biocompatible or conventional peritoneal dialysis solutions show no difference in peritonitis or technique survival
by
Srivastava, Shalabh
,
Fan, Stanley L.-S.
,
Hildebrand, Sarah
in
Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy
,
Biocompatible Materials - administration & dosage
,
Biocompatible Materials - adverse effects
2011
Peritonitis remains a common clinical problem for patients on peritoneal dialysis (PD). There are, however, retrospective studies with historical controls that suggest that biocompatible PD solutions may reduce the rates of peritonitis. We conducted a randomized controlled study comparing the use of biocompatible and conventional solutions, accumulating over 7000 patient-months experience. We included peritonitis episodes from patients who discontinued PD during the follow-up period. The study was powered to detect a reduction in the peritonitis rate of over half in the 267 randomized patients in demographically similar groups. There were no intergroup differences in PD technique survival irrespective of whether the outcome was censored for death. Peritonitis-free survival was 26.7 months using conventional compared to 23.1 months using biocompatible PD solutions. The peritonitis rates were also not statistically different when measured in patient-months. Thus, despite the finding of non-randomized studies suggesting benefits of the biocompatible PD solutions, we could not detect any clinically significant advantages in terms of technique survival or peritonitis. Although our study is the largest randomized study comparing different PD solutions to date, we do not exclude the possibility that our results are a consequence of the lack of statistical power. Meta-analysis of randomized control trials in this field is essential.
Journal Article
Changes in the worldwide epidemiology of peritoneal dialysis
by
Chow, Kai Ming
,
Jager, Kitty J.
,
Yu, Xue Qing
in
692/699/1585/104/1586
,
692/700/1538
,
692/700/478/174
2017
Key Points
Peritoneal dialysis is a high quality and cost-effective dialysis modality
In the past decade the greatest increases in peritoneal dialysis utilization have occurred in China, Thailand and the USA; peritoneal dialysis utilization has decreased in parts of Europe and in Oceania
Asia has experienced the largest absolute growth in patients on dialysis, and is characterized by the largest regional variation in peritoneal dialysis utilization
Reimbursement schemes and government policy are important determinants of peritoneal dialysis epidemiology
Peritoneal dialysis first policies (Hong Kong and Thailand), the peritoneal dialysis favoured policy (China) and the home dialysis first model (Australia and New Zealand) have resulted in increased utilization of peritoneal dialysis
Major challenges to increased utilization of peritoneal dialysis — particularly in developing countries — include prohibitive costs, lack of trained medical personnel, disparities in health-care provision and a lack of infrastructure
In many countries, patient outcomes with peritoneal dialysis are comparable or superior to those with haemodialysis. Here, the authors discuss the changing epidemiology of peritoneal dialysis worldwide, including the remaining country-specific challenges that must be overcome to improve utilization of this cost-effective therapy.
As the global burden of chronic kidney disease continues to increase, so does the need for a cost-effective renal replacement therapy. In many countries, patient outcomes with peritoneal dialysis are comparable to or better than those with haemodialysis, and peritoneal dialysis is also more cost-effective. These benefits have not, however, always led to increased utilization of peritoneal dialysis. Use of this therapy is increasing in some countries, including China, the USA and Thailand, but has proportionally decreased in parts of Europe and in Japan. The variable trends in peritoneal dialysis use reflect the multiple challenges in prescribing this therapy to patients. Key strategies for facilitating peritoneal dialysis utilization include implementation of policies and incentives that favour this modality, enabling the appropriate production and supply of peritoneal dialysis fluid at a low cost, and appropriate training for nephrologists to enable increased utilization of the therapy and to ensure that rates of technique failure continue to decline. Further growth in peritoneal dialysis use is required to enable this modality to become an integral part of renal replacement therapy programmes worldwide.
Journal Article
Rapid fluid removal during dialysis is associated with cardiovascular morbidity and mortality
by
Brunelli, Steven M.
,
Flythe, Jennifer E.
,
Kimmel, Stephen E.
in
Adult
,
Aged
,
Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy
2011
Patients receiving hemodialysis have high rates of cardiovascular morbidity and mortality that may be related to the hemodynamic effects of rapid ultrafiltration. Here we tested whether higher dialytic ultrafiltration rates are associated with greater all-cause and cardiovascular mortality, and hospitalization for cardiovascular disease. We used data from the Hemodialysis Study, an almost-7-year randomized clinical trial of 1846 patients receiving thrice-weekly chronic dialysis. The ultrafiltration rates were divided into three categories: up to 10 ml/h/kg, 10–13 ml/h/kg, and over 13 ml/h/kg. Compared to ultrafiltration rates in the lowest group, rates in the highest were significantly associated with increased all-cause and cardiovascular-related mortality with adjusted hazard ratios of 1.59 and 1.71, respectively. Overall, ultrafiltration rates between 10–13 ml/h/kg were not associated with all-cause or cardiovascular mortality; however, they were significantly associated among participants with congestive heart failure. Cubic spline interpolation suggested that the risk of all-cause and cardiovascular mortality began to increase at ultrafiltration rates over 10 ml/h/kg regardless of the status of congestive heart failure. Hence, higher ultrafiltration rates in hemodialysis patients are associated with a greater risk of all-cause and cardiovascular death.
Journal Article
Randomized controlled trial of medium cut-off versus high-flux dialyzers on quality of life outcomes in maintenance hemodialysis patients
by
Yook, Ju-Min
,
Choi, Soon-Youn
,
Park, Yeongwoo
in
692/4022/1585/104/1586
,
692/4022/1950/1544
,
Aged
2020
Medium cut-off (MCO) dialyzers help remove larger middle molecules associated with symptoms related to the accumulation of uremic retention solutes. We investigated the effect of an MCO dialyzer on the improvement of quality of life (QOL) in maintenance hemodialysis (HD) patients. Forty-nine HD patients with high-flux dialysis were randomly assigned to either an MCO (Theranova 400, Baxter) or a high-flux (FX CorDiax 80 or 60, Fresenius Medical Care) dialyzer and completed the study. QOL was assessed at baseline and after 12 weeks of treatment using the Kidney Disease Quality of Life Short Form-36, and pruritus was assessed using a questionnaire and visual analog scale. The reduction ratios of middle molecules were also evaluated. Laboratory markers, including serum albumin, did not differ between the two groups after 12 weeks. Removals of kappa and lambda free light chains were greater for MCO dialyzer than high-flux dialyzer. The MCO group had higher scores than the high-flux group in the domains of physical functioning and physical role (75.2 ± 20.8 vs. 59.8 ± 30.1,
P
= 0.042; 61.5 ± 37.6 vs. 39.0 ± 39.6,
P
= 0.047, respectively), and the MCO group had lower mean scores for morning pruritus distribution and the frequency of scratching during sleep (1.29 ± 0.46 vs. 1.64 ± 0.64,
P
= 0.034; 0.25 ± 0.53 vs. 1.00 ± 1.47,
P
= 0.023, respectively). MCO dialyzers may improve patient-reported outcomes, particularly the physical components of QOL and uremic pruritus, in patients with high-flux dialyzers.
Journal Article
A Study on the Neurological Mechanisms of the Impact of Different Dialysis Methods on Brain Structure and Functional Network Dynamic Reorganization in Patients With End‐Stage Renal Disease Undergoing Dialysis
2025
Introduction End‐stage renal disease (ESRD) is a severe condition that necessitates dialysis. Dialysis treatments, including hemodialysis and peritoneal dialysis, can affect various organs, including the brain, leading to potential cognitive decline. This study investigates the neurological effects and brain network reorganization in ESRD patients undergoing different dialysis methods. Methods A total of 120 ESRD patients were randomly divided into two groups: 60 patients undergoing hemodialysis and 60 undergoing peritoneal dialysis. Patients were followed for 1 year. Neuropsychological scales assessed cognitive function, and MRI scans were used to analyze brain structure and functional network dynamics before and after dialysis. Laboratory indicators and clinical outcomes were also recorded. Results Both dialysis methods improved renal function, but peritoneal dialysis showed more favorable effects on cognitive function, with higher MMSE and MOCA scores. MRI analysis revealed better functional brain network efficiency in the peritoneal dialysis group. No significant differences were observed in the incidence of complications between the two groups. Conclusion Although hemodialysis showed better renal function outcomes, peritoneal dialysis was associated with better cognitive performance and brain network reorganization. Both methods were safe, but peritoneal dialysis may offer neuroprotective benefits over hemodialysis in ESRD patients. Trial Registration National Health Insurance Medical Research Registration and Filing Information System: MR‐46‐22‐012452 Hemodialysis outperforms peritoneal dialysis in renal clearance and enhances brain default mode network activity, suggesting dual benefits of renal function improvement and neuroprotection.
Journal Article
Increased cancer risk in patients undergoing dialysis: a population-based cohort study in North-Eastern Italy
2019
Background
In southern Europe, the risk of cancer in patients with end-stage kidney disease receiving dialysis has not been well quantified. The aim of this study was to assess the overall pattern of risk for de novo malignancies (DNMs) among dialysis patients in the Friuli Venezia Giulia region, north-eastern Italy.
Methods
A population-based cohort study among 3407 dialysis patients was conducted through a record linkage between local healthcare databases and the cancer registry (1998–2013). Person-years (PYs) were calculated from 30 days after the date of first dialysis to the date of DNM diagnosis, kidney transplant, death, last follow-up or December 31, 2013, whichever came first. The risk of DNM, as compared to the general population, was estimated using standardized incidence ratios (SIRs) and 95% confidence intervals (CIs).
Results
During 10,798 PYs, 357 DNMs were diagnosed in 330 dialysis patients. A higher than expected risk of 1.3-fold was found for all DNMs combined (95% CI: 1.15–1.43). The risk was particularly high in younger dialysis patients (SIR = 1.88, 95% CI: 1.42–2.45 for age 40–59 years), and it decreased with age. Moreover, significantly increased DNM risks emerged during the first 3 years since dialysis initiation, especially within the first year (SIR = 8.52, 95% CI: 6.89–10.41). Elevated excess risks were observed for kidney (SIR = 3.18; 95% CI: 2.06–4.69), skin non-melanoma (SIR = 1.81, 95% CI: 1.46–2.22), oral cavity (SIR = 2.42, 95% CI: 1.36–4.00), and Kaposi’s sarcoma (SIR = 10.29, 95% CI: 1.25–37.16).
Conclusions
The elevated risk for DNM herein documented suggest the need to implement a targeted approach to cancer prevention and control in dialysis patients.
Journal Article