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Weekly Standard Kt/Vurea and Clinical Outcomes in Home and In-Center Hemodialysis.

ABSTRACT: 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.

SUBMITTER: Rivara MB

PROVIDER: S-EPMC5967669 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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Weekly Standard Kt/V<sub>urea</sub> and Clinical Outcomes in Home and In-Center Hemodialysis.

Rivara Matthew B MB Ravel Vanessa V Streja Elani E Obi Yoshitsugu Y Soohoo Melissa M Cheung Alfred K AK Himmelfarb Jonathan J Kalantar-Zadeh Kamyar K Mehrotra Rajnish R

Clinical journal of the American Society of Nephrology : CJASN 20180111 3

<h4>Background and objectives</h4>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/V<sub>urea</sub> incorporates treatment frequency, but there are limited data on its association with clinical outcomes.<h4>Design, setting, participants, & measurements</h4>We used multivariable regression to examine the association of dialysis standard Kt/V<sub>urea</sub> with BP and m ...[more]

PMID: 29326306

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Project description:IntroductionA previous study demonstrated that the surface area-normalized standard Kt/V (SAstdKt/V) was better associated with mortality than standard Kt/V (stdKt/V). This study investigates the association of SAstdKt/V and stdKt/V with mortality, anemia, and hypoalbuminemia in a larger patient cohort with a longer follow-up period.MethodsWe included adult patients on thrice-weekly hemodialysis in the USRDS database and excluded amputated patients. StdKt/V and SAstdKt/V were calculated from the available single-pool Kt/V. Patients were categorized into five groups according to their stdKt/V and SAstdKt/V: <2.00, 2.00-2.19, 2.20-2.39, 2.40-2.59, and ≥2.60. Hazard ratios (HR) and odds ratios (OR) were calculated using Cox and logistic regression analysis respectively.FindingsThere were 507,656 patients included in the analysis. The patients had a median age of 65.5 years with a median follow-up period of 2 years. Thirty-four percent died during follow-up. HRs for mortality progressively decreased as SAstdKt/V increased in both unadjusted and adjusted models. Unlike SAstdKt/V, HRs were the lowest in the categories with stdKt/V of 2.40-2.59 and they increased in the higher stdKt/V category. The adjusted HR for SAstdKt/V vs. stdKt/V were 0.68 vs. 0.62 in the category of 2.40-2.59, and 0.63 vs. 0.73 in the category of ≥2.60. The adjusted ORs for anemia progressively decreased as SAstdKt/V increased, whereas ORs decreased to the lowest in stdKt/V category 2.40-2.59 and increased in the ≥2.60 category. The adjusted ORs for hypoalbuminemia progressively decreased as SAstdKt/V and stdKt/V increased which were both 0.45 in 2.40-2.59 category and decreased to 0.29 and 0.42 in the ≥2.60 category.DiscussionSAstdKt/V is better associated with mortality, anemia, and hypoalbuminemia than stdKt/V. SAstdKt/V is a better parameter in defining hemodialysis dosing which can be calculated by an available online tool. Further studies to determine the optimal SAstdKt/V dose required to achieve improved clinical outcomes with better cost-effectiveness are needed.

Project description:BackgroundPhysical and emotional symptoms are prevalent in patients with kidney-dysfunction requiring dialysis (KDRD) and the rigors of thrice-weekly hemodialysis (HD) may contribute to deteriorated health-related quality of life. Less intensive HD schedules might be associated with lower symptom and/or emotional burden.MethodsThe TWOPLUS Pilot study was an individually-randomized trial conducted at 14 dialysis units, with the primary goal to assess feasibility and safety. Patients with incident KDRD and residual kidney function were assigned to incremental HD start (twice-weekly HD for 6 weeks followed by thrice-weekly HD) vs conventional HD (thrice-weekly HD). In exploratory analyses, we compared the two treatment groups with respect to three patient-reported outcomes measures. We analyzed the change from baseline in the score on Dialysis Symptom Index (DSI, range 0-150), Generalized Anxiety Disorder-7 (GAD-7, range 0-21), and Patient Health Questionnaire-9 (PHQ-9, range 0-27) at 6 (n = 20 in each treatment group) and 12 weeks (n = 21); with lower scores denoting lower symptom burden. Analyses were adjusted for age, race, gender, baseline urine volume, diabetes mellitus, and malignancy. Participants' views on the intervention were sought using a Patient Feedback Questionnaire (n = 14 in incremental and n = 15 in conventional group).ResultsThe change from baseline to week 6 in estimated mean score (standard error; P value) in the incremental and conventional group was - 9.7 (4.8; P = 0.05) and - 13.8 (5.0; P = 0.009) for DSI; - 1.9 (1.0; P = 0.07) and - 1.5 (1.4; P = 0.31) for GAD-7; and - 2.5 (1.1; P = 0.03) and - 3.5 (1.5; P = 0.02) for PHQ-9, respectively. Corresponding changes from week 6 to week 12 were - 3.1 (3.2; P = 0.34) and - 2.4 (5.5; P = 0.67) in DSI score; 0.5 (0.6; P = 0.46) and 0.1 (0.6; P = 0.87) in GAD-7 score; and - 0.3 (0.6; P = 0.70) and - 0.5 (0.6; P = 0.47) in PHQ-9 score, respectively. Majority of respondents felt their healthcare was not jeopardized and expressed their motivation for study participation was to help advance the care of patients with KDRD.ConclusionsThis study suggests a possible mitigating effect of twice-weekly HD start on symptoms of anxiety and depression at transition from pre-dialysis to KDRD. Larger clinical trials are required to rigorously test clinically-matched incrementally-prescribed HD across diverse organizations and patient populations.Trial registrationRegistered at ClinicalTrials.gov with study identifier NCT03740048, registration date 14/11/2018.

Project description:Background and objectivesThe relative merits of buttonhole (or blunt needle) versus rope ladder (or sharp needle) cannulation for hemodialysis vascular access are unclear.Design, setting, participants, & measurementsClinical outcomes by cannulation method were reviewed in 90 consecutive home hemodialysis patients. Initially, patients were trained in rope ladder cannulation. From 2004 on, all incident patients were started on buttonhole cannulation, and prevalent patients were converted to this cannulation method. Coprimary outcomes were arteriovenous fistula-attributable systemic infections and a composite of arteriovenous fistula loss or requirement for surgical intervention. Secondary outcomes were total arteriovenous fistula-related infections and staff time requirements. Additionally, a systematic review evaluating infections by cannulation method was performed.ResultsSeventeen systemic arteriovenous fistula-attributable infections were documented in 90 patients who were followed for 3765 arteriovenous fistula-months. Compared with rope ladder, buttonhole was not associated with a significantly higher rate of systemic arteriovenous fistula-attributable infections (incidence rate ratio, 2.71; 95% confidence interval, 0.66 to 11.09; P=0.17). However, use of buttonhole was associated with a significantly higher rate of total arteriovenous fistula infections (incidence rate ratio, 3.85; 95% confidence interval, 1.66 to 12.77; P=0.03). Initial and ongoing staff time requirements were significantly higher with buttonhole cannulation. Arteriovenous fistula loss or requirement for surgical intervention was not different between cannulation methods. A systematic review found increased arteriovenous fistula-related infections with buttonhole compared with rope ladder in four randomized trials (relative risk, 3.34; 95% confidence interval, 0.91 to 12.20), seven observational studies comparing before with after changes (relative risk, 3.15; 95% confidence interval, 1.90 to 5.21), and three observational studies comparing units with different cannulation methods (relative risk, 3.27; 95% confidence interval, 1.44 to 7.43).ConclusionButtonhole cannulation was associated with higher rates of infectious events, increased staff support requirements, and no reduction in surgical arteriovenous fistula interventions compared with rope ladder in home hemodialysis patients. A systematic review of the published literature found that buttonhole is associated with higher risk of arteriovenous fistula-related infections.

Project description: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.

Project description:Residual kidney function (RKF) contributes to improved survival in hemodialysis (HD) patients. However, it is not clear whether RKF allows a comparable survival rate in patients undergoing twice-weekly HD compared with thrice-weekly HD.We enrolled 685 patients from a prospective multicenter observational cohort. RKF and HD adequacy was monitored regularly over 3-year follow-up. Patients with RKF were divided into groups undergoing twice-weekly HD (n = 113) or thrice-weekly HD (n = 137). Patients without RKF undergoing thrice-weekly HD (n = 435) were included as controls. Fluid balance and dialysis-associated characteristics were followed and clinical outcomes evaluated using all-cause mortality and cardiovascular events (CVE).In patients with RKF, baseline and follow-up RKF were significantly higher in patients undergoing twice-weekly HD than in those undergoing thrice-weekly HD. Total Kt/V urea (dialysis plus residual renal) in patients with RKF undergoing twice-weekly HD was greater than or equal to those in patients with or without RKF undergoing thrice-weekly HD. Compared with patients with RKF undergoing thrice-weekly HD, patients with RKF undergoing twice-weekly HD had no fluid excess, but their normalized protein catabolic rate became lower since 24-month follow up. In multivariable analyses, patients with RKF undergoing twice-weekly HD had a noninferior risk of mortality (hazard ratio [HR], 0.83; 95% confidence interval [95% CI], 0.34-2.01, P = 0.68) and of CVE (HR, 0.60; 95% CI, 0.28-1.29, P = 0.19) compared with patients without RKF undergoing thrice-weekly HD. However, this group showed an independent association with a greater risk of mortality compared with patients with RKF undergoing thrice-weekly HD (HR, 4.20; 95% CI, 1.02-17.32, P = 0.04).In conclusion, patients with RKF undergoing twice-weekly HD had an increased risk of mortality compared with those undergoing thrice-weekly HD. Decisions about twice-weekly HD should consider not only RKF, but also other risk factors such as normalized protein catabolic rate.

Dataset Information

Weekly Standard Kt/Vurea and Clinical Outcomes in Home and In-Center Hemodialysis.

Publications

Weekly Standard Kt/V<sub>urea</sub> and Clinical Outcomes in Home and In-Center Hemodialysis.

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