Dataset Information

Safety and efficacy of the Tablo hemodialysis system for in-center and home hemodialysis.

ABSTRACT: 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. METHODS:A prospective, multicenter, open-label, crossover trial comparing in-center and in-home hemodialysis using Tablo. There were 4 treatment periods during which hemodialysis was prescribed 4 times per week: 1-week Run-In, 8-week In-Center, 4-week Transition, and 8-week In-Home. The primary efficacy endpoint was weekly standard Kt/Vurea ???2.1. The secondary efficacy endpoint was delivery of ultrafiltration (UF) within 10% of prescribed UF. We collected safety and usability data. FINDINGS:Thirty participants enrolled and 28 completed all trial periods. Adherence to the protocol requirement of 4 treatments per week was 96% in-center and 99% in-home. The average prescribed and delivered session lengths were 3.4?hours for both the In-Center and the In-Home periods. The primary efficacy endpoint for the intention-to-treat cohort was achieved in 199/200 (99.5%) of measurements during the In-Center period and 168/171 (98.3%) In-Home. The average weekly standard Kt/Vurea was 2.8 in both periods. The secondary efficacy UF endpoint was achieved in the ITT cohort in 94% in both in-center and in-home. Two prespecified adverse events (AEs) occurred during the In-Center period and 6 in the In-Home period. None of the AEs were deemed by investigators as related to Tablo. The median resolution time of alarms was 8?seconds in-center and 5?seconds in-home. CONCLUSION:Primary and secondary efficacy and safety endpoints were achieved during both In-Center and In-Home trial periods. This study confirms that Tablo is safe and effective for home hemodialysis use.

SUBMITTER: Plumb TJ

PROVIDER: S-EPMC7027451 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Safety and efficacy of the Tablo hemodialysis system for in-center and home hemodialysis.

Plumb Troy J TJ Alvarez Luis L Ross Dennis L DL Lee Joseph J JJ Mulhern Jeffrey G JG Bell Jeffrey L JL Abra Graham G Prichard Sarah S SS Chertow Glenn M GM Aragon Michael A MA

Hemodialysis international. International Symposium on Home Hemodialysis 20191107 1

<h4>Introduction</h4>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 caregiver ...[more]

PMID: 31697042

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Project description:BACKGROUND AND OBJECTIVES:Patients undergoing hemodialysis with a frequency other than thrice weekly are not included in current clinical performance metrics for dialysis adequacy. The weekly standard Kt/Vurea incorporates treatment frequency, but there are limited data on its association with clinical outcomes. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS:We used multivariable regression to examine the association of dialysis standard Kt/Vurea with BP and metabolic control (serum potassium, calcium, bicarbonate, and phosphorus) in patients incidental to dialysis treated with home (n=2373) or in-center hemodialysis (n=109,273). We further used Cox survival models to examine the association of dialysis standard Kt/Vurea with mortality, hospitalization, and among patients on home hemodialysis, transfer to in-center hemodialysis. RESULTS:After adjustment for potential confounders, patients with dialysis standard Kt/Vurea <2.1 had higher BPs compared with patients with standard Kt/Vurea 2.1 to <2.3 (3.4 mm Hg higher [P<0.001] for home hemodialysis and 0.9 mm Hg higher [P<0.001] for in-center hemodialysis). There were no clinically meaningful associations between dialysis standard Kt/Vurea and markers of metabolic control, irrespective of dialysis modality. There was no association between dialysis standard Kt/Vurea and risk for mortality, hospitalization, or transfer to in-center hemodialysis among patients undergoing home hemodialysis. Among patients on in-center hemodialysis, dialysis standard Kt/Vurea <2.1 was associated with higher risk (adjusted hazard ratio, 1.11; 95% confidence interval, 1.07 to 1.14) and standard Kt/Vurea ?2.3 was associated with lower risk (adjusted hazard ratio, 0.97; 95% confidence interval, 0.94 to 0.99) for death compared with standard Kt/Vurea 2.1 to <2.3. Additional analyses limited to patients with available data on residual kidney function showed similar relationships of dialysis and total (dialysis plus kidney) standard Kt/Vurea with outcomes. CONCLUSIONS:Current targets for standard Kt/Vurea have limited utility in identifying individuals at increased risk for adverse clinical outcomes for those undergoing home hemodialysis but may enhance risk stratification for in-center hemodialysis.

Project description:Background and objectivesMobile health is the health care use of mobile devices, such as smartphones. Mobile health readiness is a prerequisite to successful implementation of mobile health programs. The aim of this study was to examine the status and correlates of mobile health readiness among individuals on dialysis.Design, setting, participants, & measurementsA cross-sectional 30-item questionnaire guided by the Khatun mobile health readiness conceptual model was distributed to individuals on dialysis from 21 in-center hemodialysis facilities and 14 home dialysis centers. The survey assessed the availability of devices and the internet, proficiency, and interest in using mobile health.ResultsIn total, 949 patients (632 hemodialysis and 317 home dialysis) completed the survey. Of those, 81% owned smartphones or other internet-capable devices, and 72% reported using the internet. The majority (70%) reported intermediate or advanced mobile health proficiency. The main reasons for using mobile health were appointments (56%), communication with health care personnel (56%), and laboratory results (55%). The main reported concerns with mobile health were privacy and security (18%). Mobile health proficiency was lower in older patients: compared with the 45- to 60-years group, respondents in age groups <45, 61-70, and >70 years had adjusted odds ratios of 5.04 (95% confidence interval, 2.23 to 11.38), 0.39 (95% confidence interval, 0.24 to 0.62), and 0.22 (95% confidence interval, 0.14 to 0.35), respectively. Proficiency was lower in participants with Hispanic/Latinx ethnicity (adjusted odds ratio, 0.49; 95% confidence interval, 0.31 to 0.75) and with less than college education (adjusted odds ratio for "below high school," 0.09; 95% confidence interval, 0.05 to 0.16 and adjusted odds ratio for "high school only," 0.26; 95% confidence interval, 0.18 to 0.39). Employment was associated with higher proficiency (adjusted odds ratio, 2.26; 95% confidence interval, 1.18 to 4.32). Although home dialysis was associated with higher proficiency in the unadjusted analyses, we did not observe this association after adjustment for other factors.ConclusionsThe majority of patients on dialysis surveyed were ready for, and proficient in, mobile health. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER DIALYSIS MHEALTH SURVEY,: NCT04177277.

Project description:Rationale & objectiveObservational studies have reported a U-shaped association between blood pressure (BP) before a hemodialysis session and death. In contrast, because a linear association between out-of-dialysis-unit BP and death has been reported, home BP may be a better target for treatment. To test the feasibility of this approach, we conducted a pilot trial of treating home versus predialysis BP in hemodialysis patients.Study designA 4-month, parallel, randomized, controlled trial.Settings & participants50 prevalent hemodialysis patients in San Francisco and Seattle. Participants were randomly assigned using 1:1 block randomization, stratified by site.InterventionsTo target home systolic BP (SBP) of 100-<140 mm Hg versus predialysis SBP of 100-<140mm Hg. Home and predialysis SBPs were ascertained every 2 weeks. Dry weight and BP medications were adjusted to reach the target SBP.OutcomesPrimary outcomes were feasibility, adherence, safety. and tolerability.Results50 of 70 (71%) patients who were approached agreed to participate. All enrollees completed the study except for 1 who received a kidney transplant. In the home BP treatment group, adherence to obtaining/reporting home BP was 97.4% (and consistent over the 4 months). There was no increased frequency of high (defined as SBP>200mm Hg; 0.2% vs 0%) or low (defined as<90mm Hg; 1.8% vs 1.2%) predialysis BP readings in the home versus predialysis treatment arms, respectively. However, participants in the home BP arm had higher frequency of fatigue (32% vs 16%).LimitationsSmall sample size.ConclusionsThis pilot trial demonstrates feasibility and high adherence to home BP measurement and treatment in hemodialysis patients. Larger trials to test the long-term feasibility, efficacy, and safety of home BP treatment in hemodialysis patients should be conducted.FundersNational Institutes of Health, Satellite Healthcare, and Northwest Kidney Centers.Trial registrationRegistered at ClinicalTrials.gov with study number NCT03459807.

Project description:BackgroundDespite clinical and lifestyle advantages of home hemodialysis (HHD) compared with in-center hemodialysis (ICHD), it remains underutilized in our province. The aim of the study was to explore the patients' perception and to identify the barriers to use of HHD in Saskatchewan, Canada.ObjectivesThe primary objective of the study was to evaluate and explore patient perceptions of HHD and to identify the obstacles for adoption of HHD in Saskatchewan. The secondary objective was to examine variations in the patients' perceptions and barriers to HHD by center (main dialysis units vs satellite dialysis units).DesignThis is a cross-sectional observational survey study.SettingTwo major centers (Regina and Saskatoon) and 5 associated satellite units attached to each center across the province of Saskatchewan.PatientsWe approached all prevalent ICHD patients across Saskatchewan, 398 agreed to participate in the study.MeasurementsSelf-reported barriers to HHD were assessed using a questionnaire.MethodsA questionnaire was designed to determine the patients' perceived barriers to HHD. Descriptive statistics was used to present the data. Chi-square and Mann-Whitney U test were used to compare the patients' responses between main and satellite units.ResultsSatisfaction with current dialysis care (91%), increase in utility bills (65%), fear of catastrophic events at home (59%), medicalization of one's home (54%), and knowledge deficits toward treatment modalities (54%) were the main barriers to HHD uptake. Compared with patients dialyzing in our main units, satellite patients chose not to pursue HHD more frequently because they had greater satisfaction with their current dialysis unit care (97% vs 87%, P < .001), felt more comfortable dialyzing under the supervision of medical staff (95% vs 86%, P < .007), could not afford additional utility costs (92% vs 45%, P < .001), were unaware of the risks and benefits of HHD (83% vs 33%, P < .001), had concerns over time commitments for training to HHD (69% vs 32%, P < .001), and had concern for family burnout (60.8% vs 40.6%, P < .001).LimitationsWe used questionnaires to quantify known barriers, and this prevents inclusion of additional barriers that individual patients may consider important. Cross-sectional data can only be used as a snapshot. Only 398 patients agreed to participate, and the results cannot be generalized to 740 prevalent HD patients. We did not capture data on demographics (age, income, and literacy level), comorbidities, and dialysis vintage, which would have been helpful in interpretation of the results.ConclusionsSatisfaction with in-center care, lack of awareness and education, specifically in the satellite population, concerns with family burnout, expenses associated with utilities, and training time will need to be addressed to increase the uptake of HHD.Trial registrationThe study was not registered on a publicly accessible registry as it did not involve any health care intervention on human participants.

Dataset Information

Safety and efficacy of the Tablo hemodialysis system for in-center and home hemodialysis.

Publications

Safety and efficacy of the Tablo hemodialysis system for in-center and home hemodialysis.

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