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 NCT02280005. FUNDING The Wearable Artificial Kidney Foundation and Blood Purification Technologies Inc.

Automated methods for delivering peritoneal dialysis (PD) to persons with end-stage renal disease continue to gain popularity worldwide, particularly in developed countries. However, the endeavor to automate the PD process has not been advanced on the strength of high-level evidence for superiority of automated over manual methods. This article summarizes available studies that have shed light on the evidence that compares the association of treatment with continuous ambulatory PD or automated PD (APD) with clinically meaningful outcomes. Published evidence, primarily from observational studies, has been unable to demonstrate a consistent difference in residual kidney function loss rate, peritonitis rate, maintenance of euvolemia, technique survival, mortality, or health-related quality of life in individuals undergoing continuous ambulatory PD versus APD. At the same time, the future of APD technology appears ripe for further improvement, such as the incorporation of voice commands and expanded use of telemedicine. Given these considerations, it appears that patient choice should drive the decision about PD modality.

BackgroundLeveraging quality metrics can be a powerful approach to identify substantial performance gaps in kidney disease care that affect patient outcomes. However, metrics must be meaningful, evidence-based, attributable, and feasible to improve care delivery. As members of the American Society of Nephrology Quality Committee, we evaluated existing kidney quality metrics and provide a framework for quality measurement to guide clinicians and policy makers.MethodsWe compiled a comprehensive list of national kidney quality metrics from multiple established kidney and quality organizations. To assess the measures’ validity, we conducted two rounds of structured metric evaluation, on the basis of the American College of Physicians criteria: importance, appropriate care, clinical evidence base, clarity of measure specifications, and feasibility and applicability.ResultsWe included 60 quality metrics, including seven for CKD prevention, two for slowing CKD progression, two for CKD management, one for advanced CKD and kidney replacement planning, 28 for dialysis management, 18 for broad measures, and two patient-reported outcome measures. We determined that on the basis of defined criteria, 29 (49%) of the metrics have high validity, 23 (38%) have medium validity, and eight (13%) have low validity.ConclusionsWe rated less than half of kidney disease quality metrics as highly valid; the others fell short because of unclear attribution, inadequate definitions and risk adjustment, or discordance with recent evidence. Nearly half of the metrics were related to dialysis management, compared with only one metric related to kidney replacement planning and two related to patient-reported outcomes. We advocate refining existing measures and developing new metrics that better reflect the spectrum of kidney care delivery.

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