Safety and efficacy of the Tablo hemodialysis system for in-center and home hemodialysis.
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ABSTRACT:
SUBMITTER: Plumb TJ
PROVIDER: S-EPMC7027451 | biostudies-literature | 2020 Jan
REPOSITORIES: biostudies-literature
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Project description:More intensive and/or frequent hemodialysis may provide clinical benefits to patients with end-stage renal disease; however, these dialysis treatments are more convenient to the patients if provided in their homes. Here we created a standardized model, based on a systematic review of available costing literature, to determine the economic viability of providing hemodialysis in the home that arrays costs and common approaches for assessing direct medical and nonmedical costs. Our model was based on data from Australia, Canada, and the United Kingdom. The first year start-up costs for all hemodialysis modalities were higher than in subsequent years with modeled costs for conventional home hemodialysis lower than in-center hemodialysis in subsequent years. Modeled costs for frequent home hemodialysis was higher than both in-center and conventional home hemodialysis in the United Kingdom, but lower than in-center hemodialysis and higher than conventional home hemodialysis in Australia and Canada in subsequent years. The higher costs of frequent compared to conventional home hemodialysis were because of higher consumable usage due to dialysis frequency. Thus, our findings reinforce the conclusions of previous studies showing that home-based conventional and more frequent hemodialysis may provide clinical benefit at reasonable costs.
| S-EPMC3258566 | biostudies-other
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.
| S-EPMC5967669 | biostudies-literature
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.
| S-EPMC7792646 | biostudies-literature
Project description:Background and objectivesIn individuals undergoing in-center hemodialysis (HD), use of central venous catheters (CVCs) is associated with worse clinical outcomes compared with use of arteriovenous access. However, it is unclear whether a similar difference in risk by vascular access type is present in patients undergoing home HD.Design, setting, participants, & measurementsOur study examined the associations of vascular access type with all-cause mortality, hospitalization, and transfer to in-center HD in patients who initiated home HD from 2007 to 2011 in 464 facilities in 43 states in the United States. Patients were followed through December 31, 2011. Data were analyzed using competing risks hazards regression, with vascular access type at the start of home HD as the primary exposure in a propensity score-matched cohort (1052 patients; 526 with CVC and 526 with arteriovenous access).ResultsOver a median follow-up of 312 days, 110 patients died, 604 had at least one hospitalization, and 202 transferred to in-center hemodialysis. Compared with arteriovenous access use, CVC use was associated with higher risk for mortality (hazard ratio, 1.73; 95% confidence interval, 1.18 to 2.54) and hospitalization (hazard ratio, 1.19; 95% confidence interval, 1.02 to 1.39). CVC use was not associated with increased risk for transfer to in-center HD. The results of analyses in the entire unmatched cohort (2481 patients), with vascular access type modeled as a baseline exposure at start of home HD or a time-varying exposure, were similar. Analyses among a propensity score-matched cohort of patients undergoing in-center HD also showed similar risks for death and hospitalization with use of CVCs.ConclusionsIn a large cohort of patients on home HD, CVC use was associated with higher risk for mortality and hospitalization. Additional studies are needed to identify interventions which may reduce risk associated with use of CVCs among patients undergoing home HD.
| S-EPMC4741041 | biostudies-literature
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.
| S-EPMC7752836 | biostudies-literature
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.
| S-EPMC7418229 | biostudies-literature
Project description:Introduction:In this phase III, open-label, single-arm, multi-center 12-week study, we evaluated the efficacy and safety of combination therapy with sucroferric oxyhydroxide (PA21) and calcium carbonate for hemodialysis patients with hyperphosphatemia. Methods:We enrolled 35 subjects aged ? 20 years with end-stage kidney disease and serum phosphorus 3.5-6.0 mg/dl who were undergoing hemodialysis 3 times weekly and taking calcium carbonate and sevelamer hydrochloride. Patients switched from sevelamer hydrochloride and calcium carbonate to sucroferric oxyhydroxide and calcium carbonate. Sucroferric oxyhydroxide was orally administered 3 times daily within 750 mg/d (250 mg per dose) to 3000 mg/d (1000 mg per dose), immediately before every meal, for 12 weeks. Calcium carbonate was orally administered 3 times daily after every meal. Outcomes were serum phosphorus concentration, safety, and satisfaction with bowel movements. Results:Mean (SD) serum phosphorus concentrations were 5.01 (0.63) mg/dl at week 0 and 4.89 (1.14) mg/dl at the end of treatment, after patients switched from sevelamer hydrochloride to sucroferric oxyhydroxide. The incidence of adverse drug reactions was 31.4% (11/35), with diarrhea being the most frequent (31.4%). More sucroferric oxyhydroxide-treated patients were satisfied with their bowel movements. More patients with constipation, as well as those who experienced diarrhea, were satisfied with their bowel movements at the end of the study. Conclusion:Combined administration of sucroferric oxyhydroxide and calcium carbonate at low doses was effective in maintaining serum phosphorus concentrations within the target range, and patients' gastrointestinal status improved. Sucroferric oxyhydroxide maintained its serum phosphorus-lowering effect with a decreased pill burden, and its concomitant administration with calcium carbonate was well tolerated.
| S-EPMC5762971 | biostudies-literature
Project description:INTRODUCTION:Uptake rates of home hemodialysis are the lowest among all modality types, despite providing patients with clinical and quality of life benefits at a lower cost to providers. Currently, there is a need to develop dialysis systems that are appealing to patients while also being suitable for use across the continuum of care. The SC+ hemodialysis system was developed by Quanta Dialysis Technologies Ltd. to provide patients with a dialysis system that is small, simple to use, and powerful enough to deliver acceptable dialysis adequacy. METHODS:As part of the SC+ design validation, human factors testing was performed with 17 Healthcare Professionals (nephrology nurses and healthcare assistants) and 15 Home Users (patients and caregivers). To assess usability and safety, the human factors testing involved between 4.5 and 6?hours of training and, after a period of training decay, a subsequent test session in which participants independently performed tasks on SC+. FINDINGS:Between the two user groups, there were only 29 errors observed out of 1216 opportunities for errors, despite minimal training. Errors that did occur were minor and attributed to an initial lack of familiarity with the device; none were safety related. DISCUSSION:Among prevalent dialysis patients and healthcare professionals, the SC+ hemodialysis system was easy to use, even with minimal training and a learning decay period, and had a high level of use safety. By taking into account human factors to optimize the user experience, SC+ has the potential to address systemic and patient barriers, allowing for wider self-care and home hemodialysis adoption.
| S-EPMC6850132 | biostudies-literature
Project description:BackgroundThe passive immunization of patients with SARS-CoV2 with convalescent plasma (CP) is theoretically beneficial in patients with end-stage renal disease who are immunosuppressed and unable to mount an adequate immune response. Hence, this study was conducted to evaluate the safety and efficacy of CP in patients with chronic kidney disease on hemodialysis with moderate-to-severe SARS-CoV2 infection.MethodsA prospective observational cohort study was conducted in consecutive 68 moderate-to-severe SARS-CoV2 infected patients who were on maintenance hemodialysis or with acute worsening of chronic kidney disease which required initiation of hemodialysis. Patients who received CP were compared with those who did not. The primary outcome was death during hospitalization. Clinical characteristics, duration of hospitalization and inflammatory parameters were compared between the two groups. A subgroup analysis was done to find whether early initiation of plasma was associated with better outcome.ResultsSixteen patients (44%) in the plasma group and 14 (45%) patients in the control group died during hospitalization (p = 0.95). The median duration of hospitalization was 9 (6-14) days in the plasma group and 9 (6-16) in the control group (p = 0.60). There was no difference in mortality or duration of hospitalization with respect to early initiation of CP (p = 0.29). Fistula thrombosis occurred in two patients (11.1%) in the plasma group.ConclusionTherapy with CP does not appear to confer any clinical benefit in moderate-to-severe SARS-CoV-2 infected patients with chronic kidney disease on hemodialysis.
| S-EPMC8444855 | biostudies-literature
Project description:BackgroundIncreased right ventricular systolic pressure (RVSP), a surrogate marker for pulmonary hypertension, is common in patients with end-stage kidney disease. Limited data suggest improvement of RVSP with intensive dialysis, but it is unknown whether these improvements translate to better clinical outcomes.MethodsWe conducted a retrospective single center cohort study at the Toronto General Hospital. All patients who performed intensive home hemodialysis (IHHD) for at least a year between 1999 and 2017, and who had a baseline as well as a follow-up echocardiogram more than a year after IHHD, were included. Patients were categorized into two groups based on the RVSP at follow-up: elevated (≥ 35 mmHg) and normal RVSP. Multivariate and cox regression analyses were done to identify risk factors for elevated RVSP at follow-up and reaching the composite endpoint (death, cardiovascular hospitalization, treatment failure), respectively.ResultsOne hundred eight patients were included in the study. At baseline, 63% (68/108) of patients had normal RVSP and 37% (40/108) having elevated RVSP. After a follow-up of 4 years, 70% (76/108) patient had normal RVSP while 30% (32/108) had elevated RVSP. 8 (10%) out of the 76 patients with normal RVSP and 15 (47%) out of the 32 patients with elevated RVSP reached the composite endpoint of death, cardiovascular hospitalization or technique failure. In a multivariate analysis, age, diabetes and smoking were not associated with elevated RVSP at follow-up. Elevated RVSP at baseline was not associated with a higher likelihood in reaching the composite endpoint or mortality.ConclusionMean RVSP did not increase in patients on IHHD over time, and maintenance of normal RVSP was associated with better clinical outcomes.
| S-EPMC7687753 | biostudies-literature