Introduction: Recently published results of the investigational device exemption (IDE) trial using the Tablo hemodialysis system confirmed its safety and efficacy for home dialysis. This manuscript reports additional data from the Tablo IDE study on the training time required to be competent in self-care, the degree of dependence on health care workers and caregivers after training was complete, and participants' assessment of the ease-of-use of Tablo.
Methods: We collected data on the time required to set up concentrates and the Tablo cartridge prior to treatment initiation.
Introduction: We recently completed an Investigational Device Exemption (IDE) study in which 30 patients were enrolled (13 patients previously on home hemodialysis (HHD) and 17 patients new to HHD) and treated with the Tablo Hemodialysis System (Outset Medical, Inc., San Jose, CA) for 8 weeks in-center and 8 weeks in-home with an interim 2-4 week transition period for home training.
Methods: In addition to assessments of urea kinetics, events related to safety, and operational issues (e.
Rationale & Objective: Patients experience various symptoms during hemodialysis. We aimed to assess the frequency and severity of symptoms during hemodialysis and whether intradialytic symptoms are associated with recovery time postdialysis.
Study Design: An online questionnaire was sent to 10,000 patients in a National Kidney Foundation database.
Introduction: Home hemodialysis remains underutilized despite observational data indicating more favorable outcomes with home compared with in-center hemodialysis. The Tablo Hemodialysis system is designed to be easy to learn and use and to facilitate adoption of home hemodialysis. The objective of the current investigational device exemption (IDE) study was to evaluate the safety and efficacy of Tablo managed in-center by health care professionals and in-home by patients and/or caregivers.
View Article and Find Full Text PDFBackground: High dialysate flow rates (QD) of 500-800 mL/min are used to maximize urea removal during conventional hemodialysis. There are few data describing hemodialysis with use of mid-rate QD (300 mL/min).
Methods: We constructed uremic solute (urea, beta2-microglobulin and phosphate) kinetic models at varying volumes of distribution and blood flow rates to predict solute clearances at QD of 300 and 500 mL/min.
Introduction Home hemodialysis has not been widely adopted despite superior outcomes relative to conventional in-center hemodialysis. Patients receiving home hemodialysis experience high rates of technique failure owing to machine complexity, training burden, and the inability to master treatments independently. Methods We conducted human factors testing on 15 health care professionals (HCPs) and 15 patients upon release of the defined training program on the Tablo™ Hemodialysis System.
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Background: Extending technique survival on peritoneal dialysis (PD) remains a major challenge in optimizing outcomes for PD patients while increasing PD utilization. The primary objective of the Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS) is to identify modifiable practices associated with improvements in PD technique and patient survival. In collaboration with the International Society for Peritoneal Dialysis (ISPD), PDOPPS seeks to standardize PD-related data definitions and provide a forum for effective international collaborative clinical research in PD.
Background: Patient registries have great potential for providing data that describe disease burden, treatments, and outcomes; which can be used to improve patient care. Many renal registries exist, but a central repository of their scope, quality, and accessibility is lacking. The objective of this study was to identify and assess worldwide renal registries reporting on renal replacement therapy and compile a list of those most suitable for use by a broad range of researchers.
View Article and Find Full Text PDFBackground: To better understand the spectrum of overfill reports and their corresponding clinical severity and etiology, we conducted a review of overfill reports from the Manufacturer and User Facility Device Experience (MAUDE) database, which is within the Food and Drug Administration (FDA) Web site (www.fda.gov).
View Article and Find Full Text PDFPeritoneal dialysis (PD) enjoyed huge growth in the 1980s, followed by a rapid decline in the late 1990s, and a now persistently low utilization rate in many countries, including the United States. Recent clinical data indicate a survival advantage for patients started on PD. Residual renal function is better preserved with PD.
View Article and Find Full Text PDFHeart disease is a major cause of morbidity and mortality among patients with renal failure. Premature atherosclerotic coronary heart disease is driven by multiple risk factors, including dyslipidemia and oxidative stress. In the nondialysis population, there is overwhelming evidence that treatment of dyslipidemia can significantly improve cardiovascular outcomes.
View Article and Find Full Text PDFAll patients with CKD have multiple risk factors for CVD and CAD in particular. Some of these risk factors such as age and gender cannot be modified. Others such as diabetes and hypertension are not only CVD risk factors but are also the cause of the patient's CKD.
View Article and Find Full Text PDFCardiovascular mortality is markedly increased in patients with end-stage renal disease (ESRD), particularly those receiving dialysis. Coronary artery disease is the most important cause of death in these patients. As in the general population, older age, male gender, and the postmenopausal state in women are cardiovascular risk factors in patients with ESRD.
View Article and Find Full Text PDFDoubt has remained as to whether or not the K/DOQI recommended targets for adequacy of dialysis for peritoneal dialysis patients is appropriate (weekly Kt/V 2 + creatinine clearance 50-60 l/1.73 m(2)). The ADEMEX trial can be interpreted as indicating that lower targets might be acceptable.
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