Social determinants of health and the transition from advanced chronic kidney disease to kidney failure.

BACKGROUND: The transition from chronic kidney disease (CKD) to kidney failure is a vulnerable time for patients, with suboptimal transitions associated with increased morbidity and mortality. Whether social determinants of health are associated with suboptimal transitions is not well understood. METHODS: This retrospective cohort study included 1070 patients with advanced CKD who were referred to the Ottawa Hospital Multi-Care Kidney Clinic and developed kidney failure (dialysis or kidney transplantation) between 2010 and 2021. Social determinant information, including education level, employment status and marital status, was collected under routine clinic protocol. Outcomes surrounding suboptimal transition included inpatient (versus outpatient) dialysis starts, pre-emptive (versus delayed) access creation and pre-emptive kidney transplantation. We examined the association between social determinants of health and suboptimal transition outcomes using multivariable logistic regression. RESULTS: The mean age and estimated glomerular filtration rate were 63 years and 18 ml/min/1.73 m2, respectively. Not having a high school degree was associated with higher odds for an inpatient dialysis start compared with having a college degree {odds ratio [OR] 1.71 [95% confidence interval (CI) 1.09-2.69]}. Unemployment was associated with higher odds for an inpatient dialysis start [OR 1.85 (95% CI 1.18-2.92)], lower odds for pre-emptive access creation [OR 0.53 (95% CI 0.34-0.82)] and lower odds for pre-emptive kidney transplantation [OR 0.48 (95% CI 0.24-0.96)] compared with active employment. Being single was associated with higher odds for an inpatient dialysis start [OR 1.44 (95% CI 1.07-1.93)] and lower odds for pre-emptive access creation [OR 0.67 (95% CI 0.50-0.89)] compared with being married. CONCLUSIONS: Social determinants of health, including education, employment and marital status, are associated with suboptimal transitions from CKD to kidney failure.

Inhibit progression of coronary artery calcification with vitamin K in hemodialysis patients (the iPACK-HD study): a randomized, placebo-controlled multi-center, pilot trial.

BACKGROUND: Vitamin K activates matrix Gla protein (MGP), a key inhibitor of vascular calcification. There is a high prevalence of sub-clinical vitamin K deficiency in patients with end-stage kidney disease. METHODS: A parallel randomized placebo-controlled pilot trial was designed to determine whether 10 mg of phylloquinone thrice weekly versus placebo modifies coronary artery calcification progression over 12 months in patients requiring hemodialysis with a coronary artery calcium score (CAC) ≥30 Agatston Units (ClinicalTrials.gov identifier NCT01528800). The primary outcome was feasibility (recruitment rate, compliance with study medication, study completion and adherence overall to study protocol). CAC score was used to assess calcification at baseline and 12 months. Secondary objectives were to explore the impact of phylloquinone on vitamin K-related biomarkers (phylloquinone, dephospho-uncarboxylated MGP and the Gla-osteocalcin to Glu-osteocalcin ratio) and events of clinical interest. RESULTS: A total of 86 patients with a CAC score ≥30 Agatston Units were randomized to either 10 mg of phylloquinone or a matching placebo three times per week. In all, 69 participants (80%) completed the trial. Recruitment rate (4.4 participants/month) and medication compliance (96%) met pre-defined feasibility criteria of ≥4.17 and ≥90%, respectively. Patients randomized to phylloquinone for 12 months had significantly reduced levels of dephospho-uncarboxylated MGP (86% reduction) and increased levels of phylloquinone and Gla-osteocalcin to Glu-osteocalcin ratio compared with placebo. There was no difference in the absolute or relative progression of coronary artery calcification between groups. CONCLUSION: We demonstrated that phylloquinone treatment improves vitamin K status and that a fully powered randomized trial may be feasible.

Impact of Bioelectrical Impedance-Guided Fluid Management and Vitamin D Supplementation on Left Ventricular Mass in Patients Receiving Peritoneal Dialysis: A Randomized Controlled Trial.

RATIONALE & OBJECTIVE: Hypervolemia and vitamin D deficiency occur frequently in patients receiving peritoneal dialysis and may contribute to left ventricular (LV) hypertrophy. The effect of bioelectrical impedance analysis (BIA)-guided volume management or vitamin D supplementation on LV mass among those receiving peritoneal dialysis is uncertain. STUDY DESIGN: Two-by-two factorial randomized controlled trial. SETTING & PARTICIPANTS: Sixty-five patients receiving maintenance peritoneal dialysis. INTERVENTION: BIA-guided volume management versus usual care and oral cholecalciferol 50,000 U weekly for 8 weeks followed by 10,000 U weekly for 44 weeks or matching placebo. OUTCOME: Change in LV mass at 1 year measured by cardiac magnetic resonance imaging. RESULTS: Total body water decreased by 0.9 + 2.4 (SD) L in the BIA group compared with a 1.5 ± 3.4 L increase in the usual care group (adjusted between-group difference: -2.4 [95% CI, -4.1 to -0.68] L, P = 0.01). LV mass increased by 1.3 ± 14.3 g in the BIA group and decreased by 2.4 ± 37.7 g in the usual care group (between-group difference: +2.2 [95% CI, -13.9 to 18.3] g, P = 0.8). Serum 25-hydroxyvitamin D concentration increased by a mean of 17.2 ± 30.8 nmol/L in the cholecalciferol group and declined by 8.2 ± 24.3 nmol/L in the placebo group (between-group difference: 28.3 [95% CI, 17.2-39.4] nmol/L, P < 0.001). LV mass decreased by 3.0 ± 28.1 g in the cholecalciferol group and increased by 2.0 ± 31.2 g in the placebo group (between-group difference: -4.5 [95% CI, -20.4 to 11.5] g, P = 0.6). LIMITATIONS: Relatively small sample size with larger than expected variation in change in LV mass. CONCLUSIONS: BIA-guided volume management had a modest impact on volume status with no effect on the change in LV mass. Vitamin D supplementation increased serum vitamin D concentration but had no effect on LV mass. FUNDING: Unrestricted Baxter International extramural grant and the Kidney Foundation of Canada. TRIAL REGISTRATION: Registered at ClinicalTrials.gov with study number NCT01045980.

Complications and challenges of home hemodialysis: A historical review.

Home hemodialysis (HHD) has evolved as a preferred and safe kidney replacement modality over the past six decades. Despite advances in technological aspects of HHD, potential complications still pose a challenge to health care givers, patients, and their families. In this narrative review, we describe vascular access and cannulation, anticoagulation, nutritional, residual kidney function, psychosocial, technique failure, and machine/procedural-related complications. Addressing these problems is essential for favorable patient outcomes.

Technique Failure in a Multicenter Canadian Home Hemodialysis Cohort.

RATIONALE & OBJECTIVE: Increasing uptake of home hemodialysis (HD) has led to interest in characteristics that predict discontinuation of home HD therapy for reasons other than death or transplantation. Recent reports of practice pattern variability led to the hypothesis that there are patient- and center-specific factors that influence these discontinuations. STUDY DESIGN: Retrospective cohort study. SETTING & PARTICIPANTS: Incident home HD patients at 7 centers in Canada between 2000 and 2010. PREDICTOR: Treatment center, case-mix, and process-of-care variables. OUTCOMES: Technique failure (defined as discontinuation of home HD therapy for any reason other than training failure, death, or transplantation) and mortality. ANALYTICAL APPROACH: Regression modeling of technique failure using Cox proportional hazard models adjusting for treatment center and modifiable and nonmodifiable patient-level variables, censored for death and transplantation. RESULTS: The cohort consisted of 579 patients. Mean age was 49.9±14.1 years, 74% were of European ancestry, median dialysis vintage was 1.9 (IQR, 0.6-5.2) years, and 68% used an arteriovenous access. Mean duration of dialysis was 31.2±12.6 hours per week. Unadjusted 1- and 2-year technique survival and overall survival were 90% and 83% and 94% and 87%, respectively. Treating center was a strong predictor of technique failure and mortality, with HRs ranging from 0.37 to 5.11 for technique failure (1 of 6 centers with P<0.05 relative to the reference) and 0.17 to 8.73 for mortality (3 of 6 centers with P<0.05 relative to the reference). With baseline adjustment for center, only older age and more than 3 treatments per week remained significant predictors of technique failure, while no individual-level variables remained as significant predictors of survival. LIMITATIONS: Limited statistical power. CONCLUSIONS: Home HD treating centers may influence technique failure and patient mortality independent of case-mix. The relationship between processes of care and patient outcomes requires further investigation.

Predictors of Care Gaps in Home Dialysis: The Home Dialysis Virtual Ward Study.

BACKGROUND: Home dialysis patients may be at an increased risk of adverse events after transitional states. The home dialysis virtual ward (HDVW) trial was conducted in Canadian dialysis centers and aimed to evaluate potential care gaps and patient satisfaction during the HDVW. METHODS: The HDVW was a multicenter single-arm trial including peritoneal dialysis and home hemodialysis patients after 4 different events (hospital discharge, medical procedure, antibiotics, completion of training). Telephone-led interviews using a standardized assessment tool were performed over a 2-week period to assess a patient's care and adjust treatment as required. Upon completion, patients were surveyed to evaluate their perceived impact on domains of care using a rating scale; 1 not satisfied to 10 completely satisfied. RESULTS: The HDVW trial included 193 patients with a median number of potential care gaps/interventions of 1 (0-2) per patient. Patients admitted to the HDVW after hospital discharge were at a higher risk of potential gaps in care (OR 2.16, 95% CI 1.29-3.62), while longer dialysis vintage was -associated with a lower number of gaps/interventions (OR 0.97 per year, 95% CI 0.95-0.98). A total of 105/193 (54%) patients completed satisfaction surveys. Patients were highly satisfied with the HDVW (median rating scale score 8, IQR 2) and felt it had a positive impact (rating scale score ≥7) on their overall health, understanding of treatment and access to a nephrologist. CONCLUSION: The HDVW was effective at identifying several potential care gaps, and patients were satisfied across several domains of care. This intervention may be valuable in supporting home dialysis patients during care transitions.

Incident Atrial Fibrillation and the Risk of Congestive Heart Failure, Myocardial Infarction, End-Stage Kidney Disease, and Mortality Among Patients With a Decreased Estimated GFR.

BACKGROUND: The association of atrial fibrillation (AF), estimated glomerular filtration rate (eGFR), and adverse events remains unknown. STUDY DESIGN: Population-based retrospective cohort study from Ontario, Canada. SETTING & PARTICIPANTS: 1,422,978 adult residents with eGFRs < 90mL/min/1.73m2 from April 1, 2006, through March 31, 2015. FACTOR: A diagnosis of AF at hospitalization. OUTCOMES: Congestive heart failure (CHF), myocardial infarction (MI), end-stage kidney disease, all-cause mortality. RESULTS: All adverse events were more frequent in individuals with AF (93,414 propensity score matched) compared to no AF, and this difference was more pronounced within the first 6 months of the index date (CHF: 3.04% [AF] vs 0.28% [no AF], subdistribution HR [sHR] of 11.57 [95% CI, 10.26-13.05]; MI: 0.97% [AF] vs 0.21% [no AF], sHR of 4.76 [95% CI, 4.17-5.43]; end-stage kidney disease: 0.16% [AF] vs 0.03% [no AF], sHR of 5.84 [95% CI, 3.82-8.93]; and all-cause mortality: 6.11% [AF] vs 2.50% [no AF], HR of 2.62 [95% CI, 2.50-2.76]) than in the period more than 6 months after the index date (CHF: 6.87% [AF] vs 2.87% [no AF], sHR of 2.64 [95% CI, 2.55-2.74]; MI: 2.21% [AF] vs 1.81% [no AF], sHR of 1.24 [95% CI, 1.18-1.30]; end-stage kidney disease: 0.52% [AF] vs 0.32% [no AF], sHR of 1.75 [95% CI, 1.57-1.95]; and all-cause mortality: 15.55% [AF] vs 15.10% [no AF], HR of 1.07 [95% CI, 1.04-1.10]). The results accounted for the competing risk for mortality. eGFR level modified the effect of AF on CHF (P for interaction < 0.05). LIMITATIONS: Observational study design does not permit determination of causality; only a single outpatient eGFR measure was used; medication data were not included. CONCLUSIONS: Incident AF is associated with a high risk for adverse outcomes in patients with eGFRs < 90mL/min/1.73m2. Because the risk is exceedingly high within the first 6 months after AF diagnosis, therapeutic interventions and monitoring may improve outcomes.

Risk and complications of venous thromboembolism in dialysis patients.

Background: Contemporary data on venous thromboembolism (VTE) risk in dialysis patients are limited. Our objective was to determine the risk and complications of VTE among incident maintenance dialysis patients. Methods: We performed a retrospective cohort study using administrative databases. We included adult incident dialysis patients from 2004 to 2010 (n = 13 315). Dialysis patients were age- and sex-matched to individuals of the general population using a 1:4 ratio (n = 53 260). We determined the 3-year cumulative incidence and incidence rate (IR) of VTE, pulmonary embolism (PE) and deep venous thrombosis (DVT). We examined outcomes of bleeding and all-cause mortality following a VTE event among matched dialysis patients who did and did not experience a VTE. We used Cox proportional hazards regression models, stratified on matched sets, to calculate the hazard ratios (HRs) for all outcomes of interest. Results: VTE occurred in 1114 (8.4%) dialysis patients compared with 1233 (2.3%) individuals in the general population {IR 37.1 versus 8.1 per 1000 person-years; HR 4.5 [95% confidence interval (CI) 4.1-4.9]; adjusted HR 2.9 (95% CI 2.6-3.4)}. Both components of VTE [PE and DVT; adjusted HR 4.0 (95% CI 2.9-5.6) and HR 2.8 (95% CI 2.4-3.2), respectively] occurred more frequently in dialysis patients. Compared with dialysis patients without a VTE, those with a VTE had a higher risk of bleeding [adjusted HR 2.0 (95% CI 1.3-2.9)] and all-cause mortality [adjusted HR 2.4 (95% CI 2.0-2.8)]. Conclusions: VTE is common in dialysis patients and confers a high risk of major bleeding and all-cause mortality. Thromboprophylaxis and VTE treatment studies in dialysis patients are needed.

Reducing intra-abdominal pressure in peritoneal dialysis patients to avoid transient hemodialysis.

Patients treated with peritoneal dialysis (PD) are often required to switch to hemodialysis (HD) temporarily when they develop abdominal wall hernias and dialysate leaks, peritonitis or undergo thoracic or abdominal surgeries. There are significant risks associated with incident hemodialysis including possible central venous catheter infections, thrombosis, and need for invasive procedures. Therefore, strategies to avoid temporary transfer to hemodialysis are desirable. The increased intra-abdominal pressure associated with PD is largely responsible for the issues requiring withholding PD. However, the high intra-abdominal pressure, due to dialysate and body position, can be minimized by making changes to the peritoneal dialysis prescription. The lower intra-abdominal pressure may allow dialysate leaks, hernia repairs, and abdominal incisions time to heal as well as to facilitate earlier resumption of PD after catheter replacement. These strategies help to decrease morbidity and minimize cost to the health care system associated with modality switches and its complications.

The association of anticoagulation, ischemic stroke, and hemorrhage in elderly adults with chronic kidney disease and atrial fibrillation.

The utility of anticoagulants for ischemic stroke prophylaxis in elderly patients with chronic kidney disease (CKD) and atrial fibrillation remains uncertain. In this population-based retrospective cohort study, we determined the association of anticoagulant use with ischemic stroke or hemorrhage in elderly patients (66 years and older) with advanced chronic kidney disease (eGFR under 45 ml/min/1.73m2) and atrial fibrillation. We followed 6,544 patients with CKD and new onset atrial fibrillation, of whom 1,475 filled a prescription for an anticoagulant. We used propensity-score matched Cox proportional hazards and competing risk models to determine the time to first event of ischemic stroke, hemorrhage or mortality. After matching to examine exposure to anticoagulants, 1,417 matched pairs were identified. The crude rate of ischemic stroke and hemorrhage were 41.3 and 61.3 with anticoagulants and 34.4 and 34.3 without anticoagulants per 100 person-years, respectively. The hazard ratios of ischemic stroke, hemorrhage, and mortality for receipt of an anticoagulation prescription were 1.10 (95% confidence interval, 0.78-1.56), 1.42 (1.04-1.93), and 0.74 (0.62-0.88) as compared to non-receipt of anticoagulation. After accounting for the competing risk of death, the hazard ratios for ischemic stroke and hemorrhage were 1.12 (0.90-1.39) and 1.60 (1.31-1.97), respectively. The findings were consistent in a sensitivity analysis accounting for time varying anticoagulant exposure. Thus, in older patients with CKD and atrial fibrillation, receipt of an anticoagulant was not associated with a lower risk of ischemic stroke, but a higher risk of hemorrhage and a lower risk of mortality.

Risk of Venous Thromboembolism in Patients by Albuminuria and Estimated GFR.

BACKGROUND: The risk for venous thromboembolism (VTE) is elevated with albuminuria or a low estimated glomerular filtration rate (eGFR). However, the VTE risk due to the combined effects of eGFR and albuminuria are unknown. STUDY DESIGN: Population-based cohort study. SETTINGS & PARTICIPANTS: 694,956 adults in Ontario, Canada, from 2002 to 2012. FACTORS: eGFR and albumin-creatinine ratio (ACR). OUTCOME: VTE. RESULTS: 15,180 (2.2%) VTE events occurred during the study period. Both albuminuria and eGFR were independently associated with VTE. The association of albuminuria and VTE differed by level of eGFR (P for ACR × eGFR interaction < 0.001). After considering the competing risk for death, there was a 61% higher rate of VTE in patients with normal eGFRs (eGFRs>90mL/min/1.73m2) and heavy albuminuria (ACR>300mg/g) compared with those with normal eGFRs and no albuminuria (subdistribution HR, 1.61; 95% CI, 1.38-1.89). Among those with reduced kidney function (eGFR, 15-29mL/min/1.73m2), the risk for VTE was only minimally increased, irrespective of albuminuria (subdistribution HRs of 1.23 [95% CI, 1-1.5] and 1.09 [95% CI, 0.82-1.45] for ACR<30 and >300mg/g, respectively). LIMITATIONS: Only single determinations of ACR and eGFR were used. Diagnostic/International Classification of Diseases codes were used to define VTE. CONCLUSIONS: Albuminuria increases the risk for VTE markedly in patients with normal eGFRs compared with those with lower eGFRs.

Lower serum magnesium is associated with vascular calcification in peritoneal dialysis patients: a cross sectional study.

BACKGROUND: Coronary artery calcification (CAC) is highly prevalent among dialysis patients and is associated with increased cardiovascular and all cause mortality. Magnesium (Mg) inhibits vascular calcification in animal and in-vitro studies but whether the same effect occurs in humans is uncertain. METHODS: A single centre cross-sectional study of 80 prevalent peritoneal dialysis (PD) patients; on PD only for a minimum of 3 months. A radiologist blinded to patient status calculated their abdominal aortic calcification (AAC) scores on lateral lumbar spine radiographs, a validated surrogate for CAC. RESULTS: Eighty patients provided informed consent and underwent lumbar spine radiography. The mean serum Mg was 0.8 mmol/L (standard deviation 0.2) and mean AAC score 8.9 (minimum 0, maximum 24). A higher serum Mg level was associated with a lower AAC score (R 2 = 0.06, unstandardized coefficient [B] = -7.81, p = 0.03), and remained after adjustment for age, serum phosphate, serum parathyroid hormone, low-density lipoprotein cholesterol, smoking history, and diabetes (model adjusted R 2 = 0.36, serum Mg and AAC score B = -11.44, p = 0.00). This translates to a 0.1 mmol/L increase in serum Mg being independently associated with a 1.1-point decrease in AAC score. CONCLUSIONS: Our findings suggest that Mg may inhibit vascular calcification. If this association is replicated across larger studies with serial Mg and vascular calcification measurements, interventions that increase serum Mg and their effect on vascular calcification warrant further investigation in the PD population.

Dialysate Calcium Concentration, Mineral Metabolism Disorders, and Cardiovascular Disease: Deciding the Hemodialysis Bath.

Patients with end-stage kidney disease treated with dialysis are at increased risk to experience fractures and cardiovascular events than similar-aged people from the general population. The enhanced risk for these outcomes in dialysis patients is not completely explained by traditional risk factors for osteoporosis and cardiovascular disease. Mineral metabolism abnormalities are almost universal by the time patients require dialysis therapy, with most patients having some type of renal osteodystrophy and vascular calcification. These abnormalities have been linked to adverse skeletal and cardiovascular events. However, it has become clear that the treatment regimens used to modify the serum calcium, phosphate, and parathyroid hormone levels almost certainly contribute to the poor outcomes for dialysis patients. In this article, we focus on one aspect of mineral metabolism management; dialysate calcium concentration and the relationships among dialysate calcium concentrations, mineral and bone disorder, and cardiovascular disease in hemodialysis patients.

Clopidogrel use in end-stage kidney disease.

Clopidogrel irreversibly binds to the P2Y12 platelet receptor and acts as a potent inhibitor of platelet activation and aggregation. It is currently recommended for the prevention of cardiovascular events in patients with acute coronary syndromes, recent ischemic stroke, and peripheral arterial disease. Clopidogrel is a prodrug requiring hepatic conversion into its active metabolite. In the general population, genetic polymorphisms in the CYP2C19 gene interfering with hepatic conversion and the ABCB1 gene interfering with gut absorption of clopidogrel, account for the large interindividual response to clopidogrel and clopidogrel resistance. Chronic kidney disease (CKD) and ESKD are independent risk factors for clopidogrel resistance; 50-80% of patients with ESKD have high on-treatment residual platelet reactivity when treated with clopidogrel. This may partially explain the abysmal outcomes for patients with kidney disease post coronary intervention. Several assays are used to determine residual on-treatment platelet reactivity; however, their use in tailoring the suitability of clopidogrel treatment in patients with ESKD is unclear. Although clopidogrel decreased cardiovascular events in the general population after acute coronary syndromes and percutaneous intervention in the CURE and CREDO trials, a reanalysis of these studies in patients with CKD (eGFR <60 ml/minute) showed either a reduced or no benefit from clopidogrel treatment. ESKD patients were not represented in these two large trials; this is true for most of the trials that established clopidogrel as an integral part of the therapeutic armamentarium for cardiovascular disease. Furthermore, clopidogrel has been associated with an increased risk of death, death from bleeding, and hospitalization for bleeding in patients with ESKD. In conclusion, current evidence suggests that ESKD patients may not derive the same benefits from clopidogrel therapy as the general population and this therapy may be associated with harm. Properly designed observational studies and randomized controlled trials are needed to establish the role of clopidogrel in patients with ESKD, the use of platelet assays to tailor therapy, and the role of other antiplatelet agents such as prasugrel or ticagrelor in patients who exhibit high on-treatment residual platelet reactivity.

Trends in Arteriovenous Fistula Use at Dialysis Initiation After Automated eGFR Reporting.

The purpose of this study was to examine trends in the presence of an arteriovenous fistula (AVF) at dialysis initiation before and after eGFR reporting. All incident dialysis patients from four Canadian provinces that implemented province-wide, automated laboratory reporting of eGFR with known vascular access at dialysis initiation were included in the study (N = 25,201) from 2001 to 2010. The primary outcome was the change in proportion of patients with an AVF at dialysis initiation using an interrupted time series and adjusted multilevel logistic regression models. AVF usage at dialysis initiation decreased gradually over the study period from 19.0% to 14.6%. After implementation of automated eGFR reporting, there was attenuation in the decline in AVF usage in models adjusted for case-mix, facility, and the downward trajectory in AVF use over time. The adjusted odds ratio for initiating dialysis with an AVF 1 year post-eGFR reporting compared to pre-eGFR reporting was more pronounced in older patients (age tertile >73; OR: 1.40; 95% CI: 1.04-1.90). Laboratory-based eGFR reporting was associated with a possible attenuation in the decline of AVF at dialysis initiation and this was more pronounced in older patients.

Meal phosphate variability does not support fixed dose phosphate binder schedules for patients treated with peritoneal dialysis: a prospective cohort study.

BACKGROUND: Removal of phosphate by peritoneal dialysis is insufficient to maintain normal serum phosphate levels such that most patients must take phosphate binders with their meals. However, phosphate 'counting' is complicated and many patients are simply prescribed a specific dose of phosphate binders with each meal. Therefore, our primary objective was to assess the variability in meal phosphate content to determine the appropriateness of this approach. METHODS: In this prospective cohort study, adult patients with ESRD treated with peritoneal dialysis and prescribed phosphate binder therapy were eligible to participate. Participants were excluded from the study if they were unable to give consent, had hypercalcemia, were visually or hearing impaired or were expected to receive a renal transplant during the time of the study. After providing informed consent, patients kept a 3-day diet diary that included all foods and beverages consumed in addition to portion sizes. At the same time, patients documented the amount of phosphate binders taken with each meal. The phosphate content of the each meal was estimated using ESHA Food Processor SQL Software by a registered dietitian. Meal phosphate and binder variability were estimated by the Intra Class Correlation Coefficient (ICC) where 0 indicates maximal variability and 1 indicates no variability. RESULTS: Seventy-eight patients consented to participate in the study; 18 did not complete the study protocol. The patients were 60 (± 17) years, predominately male (38/60) and Caucasian (51/60). Diabetic nephropathy was the most common cause of end stage kidney disease. The daily phosphate intake including snacks ranged from 959 ± 249 to 1144 ± 362 mg. The phosphate ICC by meal: breakfast 0.63, lunch 0.16; supper 0.27. The phosphate binder ICC by meal: breakfast 0.68, lunch 0.73, supper 0.67. CONCLUSION: The standard prescription of a set number of phosphate binders with each meal is not supported by the data; patients do not appear to be adjusting their binders to match the meal phosphate content. An easy to use phosphate counting program that assists the patient in determining the appropriate amount of phosphate binder to take may enhance phosphate control.

An economic evaluation of rt-PA locking solution in dialysis catheters.

In a recent randomized trial, weekly recombinant tissue plasminogen activator (rt-PA), 1 mg per lumen, once per week, and twice-weekly heparin as a locking solution (rt-PA/heparin) resulted in lower risks of hemodialysis catheter malfunction and catheter-related bacteremia compared with thrice-weekly heparin (heparin alone). We collected detailed costs within this trial to determine how choice of locking solution would affect overall health care costs, including the cost of locking solutions and all other relevant medical costs over the course of the 6-month trial. Nonparametric bootstrap estimates were used to derive 95% confidence intervals (CIs) and mean cost differences between the treatment groups. The cost of the locking solution was higher in patients receiving rt-PA/heparin, but this was partially offset by lower costs for managing complications. Overall, the difference in unadjusted mean cost for managing patients with rt-PA/heparin versus heparin alone was Can$323 (95% CI, -$935 to $1581; P=0.62). When the costs were extrapolated over a 1-year time horizon using decision analysis, assuming ongoing rt-PA effectiveness, the overall costs of the strategies were similar. This finding was sensitive to plausible variation in the frequency and cost of managing patients with catheter-related bacteremia, and whether the benefit of rt-PA on catheter-related bacteremia was maintained in the long term. In summary, we noted no significant difference in the mean overall cost of an rt-PA/heparin strategy as a locking solution for catheters compared with thrice-weekly heparin. Cost savings due to a lower risk of hospitalization for catheter-related bacteremia partially offset the increased cost of rt-PA.

Procedure-related serious adverse events among home hemodialysis patients: a quality assurance perspective.

BACKGROUND: There has been resurgent interest in home hemodialysis (HD) in recent years because of the reported benefits and its excellent safety record. However, the potential for adverse events, including potentially catastrophic ones, exists when patients are performing HD in their homes without supervision. There is a lack of literature on this important topic. STUDY DESIGN: Quality improvement report. SETTING & PARTICIPANTS: We present the experience of 2 adult home HD programs in Canada from 2001 to 2012, including a total of 190 patients and approximately 500 patient-years of treatments. QUALITY IMPROVEMENT PLAN: We retrospectively reviewed all life-threatening adverse events occurring in our programs and re-examined our approach to patient training, retraining, and safety monitoring. RESULTS: We report 1 death and 6 potentially fatal adverse events, yielding a crude rate of 0.060 events/1,000 dialysis treatments. Six of 7 events involved significant blood loss (including 1 exsanguination); 5 of 7 events involved human error with lapses in protocol adherence. Because such events are rare, evaluation of specific intervention strategies will require much longer follow-up. LIMITATIONS: Retrospective identification of cases. A specific quality improvement initiative was not undertaken. CONCLUSIONS: Life-threatening adverse events in home HD are uncommon; however, when one does occur, this should prompt review of home HD-related policies and procedures to make this therapy even safer.

Serum testosterone levels and clinical outcomes in male hemodialysis patients.

BACKGROUND: Studies linking low serum testosterone concentration to adverse clinical outcomes in hemodialysis patients have been relatively small. We investigated the role of testosterone in adverse outcomes and quality of life in an incident cohort of male Canadian hemodialysis patients. STUDY DESIGN: A prospectively designed multicenter observational study using data from the Canadian Kidney Disease Cohort Study (CKDCS). SETTING & PARTICIPANTS: Male patients initiating hemodialysis therapy since February 14, 2005, in 3 Canadian centers serving ethnically diverse populations were studied (N = 623). PREDICTOR: Serum testosterone levels using the International Society of Andrology, International Society for the Study of the Aging Male, and European Association of Urology cutoffs (low, <231 ng/dL; borderline, 231-346 ng/dL; normal, >346 ng/dL). OUTCOMES: All-cause mortality, fatal and nonfatal cardiovascular (CV) events, and Health Utility Index (HUI)-assessed health-related quality of life. MEASUREMENTS: Participants completed a structured interview on demographics and medical history and an HUI questionnaire (version 3). Routine laboratory test results captured into the study database, and serum testosterone measured within 3 months after initiation of the baseline hemodialysis session. RESULTS: During a median follow-up of 20 (range, 1-81) months, 166 (27%) died and 98 (20%) had a CV event. Mean serum testosterone level was 234.1 ± 146.1 (SD) ng/dL. Higher serum testosterone levels were associated with significantly decreased unadjusted risk of death (HR per 10-ng/dL increase, 0.58; 95% CI, 0.37-0.90). There was a statistically significant trend for higher all-cause mortality with low serum testosterone levels in adjusted analyses (P < 0.001). Higher levels of log-transformed testosterone were associated with significantly higher HUI scores (P for trend <0.001), and low levels of serum testosterone were associated significantly with lower HUI scores (P for trend <0.001). Although there was a significant trend in the unadjusted risk of CV events among participants with low serum testosterone levels (P < 0.001), the risk was no longer significant after adjustment for age. There was no significant interaction with age and serum testosterone level tested as continuous variables (P = 0.07). LIMITATIONS: A short follow-up period and serum testosterone measured on a single occasion. CONCLUSIONS: Low serum testosterone concentration may be a modifiable risk factor for adverse outcomes and poor quality of life in male hemodialysis patients. This hypothesis should be tested in randomized controlled trials.