Conventional Hemodialysis Group Research Articles

Comparative effectiveness of an individualized model of hemodialysis vs conventional hemodialysis: a study protocol for a multicenter randomized controlled trial (the TwoPlus trial)

BackgroundMost patients starting chronic in-center hemodialysis (HD) receive conventional hemodialysis (CHD) with three sessions per week targeting specific biochemical clearance. Observational studies suggest that patients with residual kidney function can safely be treated with incremental prescriptions of HD, starting with less frequent sessions and later adjusting to thrice-weekly HD. This trial aims to show objectively that clinically matched incremental HD (CMIHD) is non-inferior to CHD in eligible patients.MethodsAn unblinded, parallel-group, randomized controlled trial will be conducted across diverse healthcare systems and dialysis organizations in the USA. Adult patients initiating chronic hemodialysis (HD) at participating centers will be screened. Eligibility criteria include receipt of fewer than 18 treatments of HD and residual kidney function defined as kidney urea clearance ≥3.5 mL/min/1.73 m2 and urine output ≥500 mL/24 h. The 1:1 randomization, stratified by site and dialysis vascular access type, assigns patients to either CMIHD (intervention group) or CHD (control group). The CMIHD group will be treated with twice-weekly HD and adjuvant pharmacologic therapy (i.e., oral loop diuretics, sodium bicarbonate, and potassium binders). The CHD group will receive thrice-weekly HD according to usual care. Throughout the study, patients undergo timed urine collection and fill out questionnaires. CMIHD will progress to thrice-weekly HD based on clinical manifestations or changes in residual kidney function. Caregivers of enrolled patients are invited to complete semi-annual questionnaires. The primary outcome is a composite of patients’ all-cause death, hospitalizations, or emergency department visits at 2 years. Secondary outcomes include patient- and caregiver-reported outcomes. We aim to enroll 350 patients, which provides ≥85% power to detect an incidence rate ratio (IRR) of 0.9 between CMIHD and CHD with an IRR non-inferiority of 1.20 (α = 0.025, one-tailed test, 20% dropout rate, average of 2.06 years of HD per patient participant), and 150 caregiver participants (of enrolled patients).DiscussionOur proposal challenges the status quo of HD care delivery. Our overarching hypothesis posits that CMIHD is non-inferior to CHD. If successful, the results will positively impact one of the highest-burdened patient populations and their caregivers.Trial registrationClinicaltrials.gov NCT05828823. Registered on 25 April 2023.

#867 Calciprotein particles and phosphorus in conventional and extended-hours hemodialysis

Abstract Background and Aims Extended-hours hemodialysis (HD) has better clinical outcomes than conventional HD. Previous studies have shown that a prolonged dialysis treatment time is associated with lower serum phosphorus levels, but the impact of extended-hours HD on calciprotein particles (CPP) is unknown. We investigated whether extended-hour HD and conventional HD have varying effects on blood levels of CPP and phosphorus, which have been identified as the main pathogenic molecules for vascular calcification. Method We performed a cross-sectional study of patients with extended-hours HD or conventional HD between January and March 2020. Blood CPP levels were measured in plasma and serum predialysis samples using a previously reported "gel filtration method". Linear and nonlinear associations between CPP and serum phosphorus levels were examined across dialysis modalities. Results A total of 382 participants (185 with extended-hours HD and 197 with conventional HD) were included in the analysis. The median age of participants was 71 years, 65% of the patients were men, and the mean phosphorus level was 5.4 mg/dL. Extended-hours HD was associated with lower plasma CPP levels (Extended-hours HD vs Conventional HD; 40,018 AU vs 75,728 AU) and serum CPP levels (Extended-hours HD vs Conventional HD; 66,524 AU vs 100,812 AU), regardless of similar serum phosphorus levels. Multivariable linear regression analysis showed that extended-hours HD was associated with lower natural logarithmic plasma CPP levels: -0.64 (95% CI: -0.74 to -0.55). Restricted cubic spline function indicated that extended-hours HD was associated with lower plasma CPP levels across levels of serum phosphorus, with significant differences observed between groups, especially in hyperphosphatemic conditions (P for interaction <0.01). Conclusion The patients with extended-hours HD had lower CPP levels than those with the conventional HD group despite no significant differences in serum phosphorus levels, which may contribute to better clinical outcomes in patients on extended-hours HD.

Association of calciprotein particles with serum phosphorus among patients undergoing conventional and extended-hours haemodialysis.

Extended-hours haemodialysis (HD) is associated with better clinical outcomes than conventional HD. We investigated whether extended-hours HD and conventional HD have varying effects on blood levels of calciprotein particles (CPPs) and phosphorus, which have been identified as major pathogenic molecules for vascular calcification. Patients who underwent conventional or extended in-centre daytime HD between January and March 2020 were included. Plasma CPP levels, representing only secondary CPPs (CPP-II), were measured in pre-dialysis samples. Linear and non-linear associations between CPPs and serum phosphorus levels were examined across dialysis modalities. A total of 382 participants (185 undergoing extended-hours HD and 197 undergoing conventional HD) were included in the analysis. The median age of participants was 71years, 65% of the patients were men and the mean phosphorus level was 5.4mg/dl. Plasma CPP (CPP-II) levels were lower in the extended-hours HD group than in the conventional HD group [40018(arbitrary units) AU versus 75728AU; P<.01]. Multivariable linear regression analysis showed that extended-hours HD was associated with lower natural logarithmic plasma CPP (CPP-II) levels: -0.64 (95% confidence interval -0.74 to -0.55). A restricted cubic spline function indicated that extended-hours HD was associated with lower plasma CPP (CPP-II) levels across levels of serum phosphorus, with significant differences observed between groups, especially in hyperphosphataemic conditions (P for interaction <.01). The extended-hours HD group had lower CPP levels than the conventional HD group despite no significant differences in serum phosphorus levels, which may contribute to better clinical outcomes in patients on extended-hours HD.

Exploring the impact of short daily haemodialysis on muscle strength and bone health in end-stage kidney disease patients.

Short-daily haemodialysis (SDH) has been strongly recommended over conventional haemodialysis (CHD) for end-stage kidney disease patients, though few studies have directly compared the effects of these two haemodialysis (HD) modalities on clinical variables related to patient's health. We conducted a cross-sectional study in individuals undergoing HD, comparing epidemiological, clinical, metabolic, inflammatory, anthropometric, bone health/metabolism, and skeletal muscle function according to dialysis modality. One-hundred seventy-eight patients (20.8% females, 62±2.5years old), were analysed in this study, 86 (48%) of whom were undergoing CHD versus 92 (51%) who were undergoing SDH. SDH patients had significantly higher serum albumin levels (3.93 vs. 3.66g/dL, P<0.0001) and higher Kt/v (2.6 vs. 2.38, P<0.0001). SDH group presented a significantly lower number of erythropoietin-stimulating agents compared with CHD group (percentage: 53.3 vs. 83.7%, P<0.0001) and had lower levels of serum phosphate (4.9 vs. 5.3mg/dL, P=0.004) and parathyroid hormone (PTH) (398.4 vs. 480.4pg/mL, P<0.001) compared with CHD patients. In terms of bone health and metabolism, SDH patients had significantly higher total BMD, femur BMD, lumbar BMD, and femoral neck BMD compared with CHD patients (all P<0.05). SDH patients also had lower anti-osteogenic and inflammatory biomarkers, including FGF23, sclerostin, TNF, IL-18, IL-17a, and C-reactive peptide (all P<0.05). CHD modality was demonstrated to be a risk factor for low BMD (odds ratio: 4.02; 95% CI: 1.59-10.2, P=0.003). In terms of skeletal muscle function, SDH patients had significantly higher 6-minute walking test (444.6 vs. 424.9m, P=0.04) and higher fat-free mass (52.3 vs. 51.68kg, P=0.02) compared with CHD patients. Higher fat-free mass and handgrip strength were associated with a 34% and 23% lower risk of low BMD, respectively. SDH patients had lower levels of the uremic toxin asymmetric dimethyl-l-arginine (ADMA) (1.8 vs. 2.07μM, P=0.002) and fasting blood glucose (132.6 vs. 141.7mg/dL, P<0.02) than CHD group. SDH patients also displayed higher levels of haemoglobin when compared with CHD group (11.9 vs. 10.2g/dL, P<0.0001). The present study improves our understanding of the relationship between dialysis modality and clinical variables that may influence HD patient's health. Grip strength and lean mass were positively correlated with bone mineral density in HD patients regardless of dialysis modality. SDH was associated with better bone mineral density, inflammatory profile, and skeletal muscle function when compared with CHD patients. These findings provide more evidence of the clinical benefits of SDH that should be explored in greater detail.

Neurocognitive Function with Conventional Hemodialysis versus Post-Dilution Hemofiltration as Initial Treatment in ESKD Patients: A Randomized Controlled Trial – The DA-VINCI Study

Introduction: The ideal modality choice and dialysis prescription during the first renal replacement therapy (RRT) session remain unclear. We conducted a pilot study to determine the safety risk for hemodialysis (HD) versus hemofiltration (HF) and its relationship with neurocognitive assessment on incident RRT patients. Methods: Twenty-four incident RRT patients were included. Patients were randomized to the conventional HD group or post-dilution HF group. Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MOCA) tests were applied in all patients before and after session, and brain magnetic resonance image (MRI) was performed in 7 patients from the conventional HD group and 8 patients from the post-dilution HF group before and after the intervention. Results: Baseline characteristics were similar between groups. Compared to conventional HD, post-dilution HF had longer treatment time. There were no significant changes in blood pressure after RRT in both groups. The MMSE test showed no significant differences between groups or within groups. The MOCA test showed an increase in the total score for the post-dilution HF group with no significant changes between groups. The MRI evaluation showed no differences between or within groups. Conclusion: Post-dilution HF is a safe alternative for the first HD session in incident RRT; it allows longer treatment time if ultrafiltration is required and has a similar neurological risk than conventional HD. This is a pilot study and that larger studies are needed to confirm the findings.

Long term reduction of cardiovascular risk factors associated with three hour daily dialysis: A prospective, cohort study.

Daily hemodialysis (DHD) compared to conventional hemodialysis (CHD) leads to improvements in left ventricular hypertrophy and mineral metabolism at 1-year follow-up. However, there is no information from prospective studies on the long terms effects of DHD on these key cardiovascular risk factors. We conducted a 4 year, prospective cohort study of 26 DHD and 51 matched CHD patients on the effect of DHD (six sessions/week × 3 h) versus CHD (three sessions/week × 4 h), 15 DHD, and 26 CHD patients completed 4-years follow-up. Measures of left ventricular mass index (LVMI), blood pressures, hemoglobin, and mineral metabolism markers were performed. Systolic and diastolic blood pressures were significantly lower in the DHD group than the CHD group at 4-year follow-up, 128 mmHg (95% CI, 111-143) versus 148 mmHg (95% CI, 137-158) (p < 0.05) and 60 mmHg (95% CI, 56-63) versus 71 mmHg (95% CI, 64-76) (p < 0.05). DHD was associated with fewer patients taking any anti-hypertensive drug therapy than CHD, 50% versus 80% (p < 0.05). DHD was associated with improved attainment of mineral metabolism goals for phosphorus (adjusted HR 3.6, p = 0.002) and calcium × phosphorus product (adjusted HR 3.66, p = 0.001) at 4-years follow-up compared to CHD. At 4 years, there was a nonsignificant trend toward lower LVMI in the DHD than in the CHD group: 116 g/m2 (95% CI, 97-136) versus 138 g/m2 (95% CI, 115-172) (p = 0.23). Similarly, improvements in hemoglobin also persisted at 4 years follow-up. DHD is associated with long-term (4 year) improvements in key cardiovascular risk factors: blood pressure, mineral metabolism, and anemia with trends toward improved LVMI.

In-center Nocturnal Hemodialysis Reduced the Circulating FGF23, Left Ventricular Hypertrophy, and All-Cause Mortality: A Retrospective Cohort Study.

Fibroblast growth factor 23(FGF23) is the most important biomarker and pathogenic factor in Chronic Kidney Disease–Mineral and Bone Disorder (CKD–MBD). In the moderate and severe stages of chronic renal failure, abnormally elevated circulating FGF23 can lead to some complications, including myocardial hypertrophy, which is positively correlated with all-cause mortality. However, the circulating FGF23 level of different hemodialysis modalities, the underlying essential regulatory factors, and potential clinical benefits remain to be elucidated. In this retrospective cohort study, 90 in-center nocturnal hemodialysis (INHD) and 90 matched conventional hemodialysis (CHD) patients were enrolled. The complete blood count, intact FGF23(iFGF23), calcium, phosphorus, PTH, and other biochemical and echocardiographic parameters of INHD and CHD patients were collected and analyzed at 1-year follow-up. The all-cause mortality was recorded during the 7-year follow-up. Furthermore, the regulatory factors of iFGF23 and its association with echocardiographic parameters and mortality were investigated by multivariate regression. The levels of iFGF23 and serum phosphate in patients undergoing INHD were significantly lower than those in patients undergoing CHD. The left ventricular volume index (LVMI) in patients with INHD was significantly attenuated and positively correlated with the drop of serum iFGF23. The INHD group had reduced all-cause mortality compared to the CHD group. Multivariate analysis showed that iFGF23 was positively correlated with serum calcium, serum phosphorus, and calcium-phosphate product. The calcium-phosphate product is an independent determining factor of serum iFGF23. Compared with the CHD group, the INHD group presented with a significantly reduced circulating iFGF23 level, which was closely associated with attenuation of left ventricular hypertrophy, but INHD reduced all-cause mortality in an FGF23 independent manner.

Twice-Weekly Hemodialysis With Adjuvant Pharmacotherapy and Transition to Thrice-Weekly Hemodialysis: A Pilot Study

Thrice-weekly hemodialysis (HD) is the most common treatment modality for kidney failure in the United States. We conducted a pilot study to assess the feasibility and safety of incremental-start HD in patients beginning maintenance HD. Pilot study. Adults with estimated glomerular filtration rate (eGFR)≥5 mL/min/1.73 m2 and urine volume≥500 mL/d beginning maintenance HD at 14 outpatient dialysis units. Randomized allocation (1:1 ratio) to twice-weekly HD and adjuvant pharmacologic therapy for 6 weeks followed by thrice-weekly HD (incremental HD group) or thrice-weekly HD (conventional HD group). The primary outcome was feasibility. Secondary outcomes included changes in urine volume and solute clearance. Of 77 patients invited to participate, 51 consented to do so, representing 66% of eligible patients. We randomized 23 patients to the incremental HD group and 25 patients to the conventional HD group. Protocol-based loop diuretics, sodium bicarbonate, and patiromer were prescribed to 100%, 39%, and 17% of patients on twice-weekly HD, respectively. At a mean follow-up of 281.9 days, participant adherence was 96% to the HD schedule (22 of 23 and 24 of 25 in the incremental and conventional groups, respectively) and 100% in both groups to serial timed urine collection. The incidence rate ratio for all-cause hospitalization was 0.31 (95% CI, 0.08-1.17); and 7 deaths were recorded (1 in the incremental and 6 in the conventional group). At week 24, the incremental HD group had lower declines in urine volume (a difference of 51.0 [95% CI,-0.7 to 102.8] percentage points) and in the averaged urea and creatinine clearances (a difference of 57.9 [95% CI,-22.6 to 138.4] percentage points). Small sample size, time-limited twice-weekly HD. It is feasible to enroll patients beginning maintenance HD into a randomized study of incremental-start HD with adjuvant pharmacotherapy who adhere to the study protocol during follow-up. Larger multicenter clinical trials are indicated to determine the efficacy and safety of incremental HD with longer twice-weekly HD periods. Funding was provided by Vifor Inc. Registered at ClinicalTrials.gov, identifier NCT03740048.

POS-599 EXTENDED-HOURS HEMODIALYSIS WITH LIBERALIZED DIET IS ASSOCIATED WITH REDUCED RISK OF NON-CARDIOVASCULAR MORTALITY IN ELDERLY DIALYSIS PATIENTS

As the world’s population ages, it is becoming more difficult to improve a prognosis of dialysis patients. Moreover, there are growing concerns about strict dietary restrictions on elderly hemodialysis (HD) patients and consequently the deterioration of nutritional status. Extended-hours HD (≥6 hours per session) is able to offer a liberalized dietary intake strategy as well as better metabolic status and hemodynamic stability. Our hypothesis is that extended-hours HD without dietary restrictions improves survival especially in non-cardiovascular mortality in elderly dialysis patients who are prone to malnutrition. The aim of the present study was to clarify the association between extended-hours HD and non-cardiovascular mortality comparing to conventional HD. A retrospective cohort study including 198 consecutive patients who started in-center daytime extended-hours HD (Extended-HD) and 1407 consecutive patients who initiated conventional HD of less than 6 hours per session (Conventional HD) was performed. The main outcome was non-cardiovascular death. The baseline was defined as the time to start outpatient maintenance dialysis. Patients were followed from baseline up to the first 5 years. Kaplan-Meier analysis was used for the survival analysis. The association between treatment groups and non-cardiovascular mortalitywere analyzed using Cox proportional hazard model with multivariable adjustments and propensity-score based method. We also examined competing risk analysis setting the competing event as cardiovascular death. Multivariable adjustment was performed using age, sex, body mass index, serum albumin, hemoglobin, diabetes, cardiovascular disease, malignancy, and vascular accesses. The median age was 67.1 [54.7-75.5] years in the Extended-HD and 70.7 [62.1-78.0] years in the Conventional HD group. Extended-HD group had a higher prevalence of diabetes (63% vs. 55%) compared to the Conventional HD group. During a median follow-up period of 3.6 years, 225 non-cardiovascular deaths were observed. Extended-HD group showed better event-free survival on non-cardiovascular mortality than Conventional HD overall and for the subgroup >70 years of age on Kaplan-Meier analysis (log-rank P < 0.001, P = 0.002, respectively). In the fully adjusted Cox proportional hazard model, Extended-HD was associated with a reduced risk of non-cardiovascular mortality in overall patients and the subgroup >70 years (adjusted hazard ratios of 0.39 [95% CI, 0.17-0.88] and 0.20 [95% CI, 0.05-0.81], respectively). The competing risk regression model with fully adjustment also suggested the lower risk of non-cardiovascular mortality in the Extended-HD than the Conventional HD (subdistribution hazard ratio of 0.46 [95% CI, 0.23-0.93]). In-center daytime extended-hours HD with liberalized dietary approach was associated with a lower risk of non-cardiovascular mortality than conventional HD. This relationship was also evident in subgroup of elderly patients aged over 70 years.

Impact of old age on the association between in-center extended-hours hemodialysis and mortality in patients on incident hemodialysis.

With the global problem of aging, it has become more difficult to improve the prognosis of older dialysis patients. Extended-hours hemodialysis offers longer treatment time compared to conventional hemodialysis regimen and provides favorable metabolic status, hemodynamic stability, and increased dietary intake. Despite prior studies reporting that in-center extended-hours hemodialysis can reduce the mortality rate, the treatment impact on elderly patients remains unclear. Therefore, we examined the association between extended-hours hemodialysis compared to conventional hemodialysis and all-cause mortality. Survival analyses using Cox proportional hazard model with multivariable adjustments and propensity-score based method were performed to compare mortality risk between 198 consecutive patients who started in-center extended-hours hemodialysis (Extended-HD) and 1407 consecutive patients who initiated conventional hemodialysis. The median age was 67.1 years in the Extended-HD group and 70.7 years in the conventional hemodialysis group. Extended-HD was associated with lower all-cause mortality in overall patients and the subgroup >70 years (adjusted hazard ratios of 0.60 [95% CI, 0.39–0.91] and 0.35 [95% CI, 0.18–0.69], respectively). There was a significant interaction between age >70 years and Extended-HD. In conclusion, extended-hours hemodialysis was associated with a lower mortality rate, especially in elderly patients.

P1083A TRANSITIONAL REGIME OF INCREMENTAL HAEMODIALYSIS IN PATIENTS WITH END-STAGE RENAL DISEASE (ENDURE): A FEASIBILITY TRIAL

Abstract Background and Aims Mortality rates are high in patients starting long-term haemodialysis (HD) therapy, particularly in the first 6-months. Incremental HD has been proposed as a means of making patients’ transition into long-term HD treatment less physiologically demanding with reduced burden of treatment at the start. A feasibility study is being conducted with the primary aim of evaluating the acceptability, tolerance and safety of a novel incremental HD regime. The secondary aims are to study the effect of incremental HD on residual renal function (RRF), fluid load, quality of life, functional status, blood pressure and blood markers of renal anaemia, secondary hyperparathyroidism and cardiac load. Method The regime being tested aims to start patients on twice-weekly HD with progressive increases in the duration and frequency of sessions over approximately 15 weeks (figure 1). 40 patients from pre-dialysis clinics, who have been referred for start of long-term HD therapy, will receive the study regime (incremental HD group). They will be followed-up for 12 months. Acceptability and tolerance will be gauged by documenting rates of participation and retention in the study. Completion rate of each study test will be recorded to evaluate the feasibility of their inclusion in a future trial; these tests include: 24-hour urine collection to measure RRF, bio-impedance analysis for estimation of overhydration, six-minute walk test to monitor performance status and a quality-of-life questionnaire. Rates of pre-defined safety events will be recorded and compared to a cohort of 40 matched patients who previously started conventional HD (historical controls, conventional HD group). Blood tests for estimation of RRF and markers of renal anaemia, bone disease and cardiac load will be performed at regular intervals and compared to the conventional HD group. Results Eight months in to the 18-month recruitment period, 106 patients have been screened for participation in the trial. Of these, 47 (43%) met eligibility criteria. Reasons for exclusions were: patient choosing other dialysis modalities over HD, 34; clinically unsuitable for incremental HD, 7; dialysis modality undetermined, 6; already started HD, 5; for conservative (non-dialysis) management, 4; non-compliant with treatment, 3. Of the 47 eligible patients, 35 have been approached by the study team. Of these, 16 (46%) have been consented, 10 (28%) declined and 9 (26%) remain undecided. Patients who consented were relatively older compared to those who declined (68 vs. 58 years) and to all eligible patients (68 vs. 63 years). Men were more likely to decline than women (M:F ratio 1.3 vs 4.0 among participants and decliners respectively). Not all study participants have started treatment yet. Baseline characteristics of the first 6 patients starting incremental HD and their matched controls are shown in table 1. Conclusion The ENDURE study tests the feasibility of starting patients on a novel incremental HD regime. This regime is relatively short and has fixed increments in treatment times. It aims to make patient transition smoother in to dialysis dependency. Early data point towards an encouraging levels of patient interest in the study. The outcome of this trial will be used to design a future RCT of incremental HD vs. conventional treatment.

Cardiac MRI measurements of pericardial adipose tissue volumes in patients on in-centre nocturnal hemodialysis.

Conversion from conventional hemodialysis (CHD) to in-centre nocturnal hemodialysis (INHD) is associated with left ventricular (LV) mass regression, but the underlying mechanisms are not fully understood. Using cardiac MRI (CMR), we examined the effects of INHD on epicardial adipose tissue (EAT) and paracardial adipose tissue (PAT), and the relationships between EAT, PAT and LV remodeling, biomarkers of nutrition, myocardial injury, fibrosis and volume. We conducted a prospective multicenter cohort study of 37 patients transitioned from CHD to INHD and 30 patients on CHD (control). Biochemical markers and CMR were performed at baseline and 52weeks. CMR images were analyzed by independent readers, blinded to order and treatment group. Among 64 participants with complete CMR studies at baseline (mean age 54; 43% women), there were no significant differences in EAT index(60.6 ± 4.3mL/m2 vs 64.2 ± 5.1mL/m2, p = 0.99) or PATindex (60.0 ± 5.4mL/m2 vs 53.2 ± 5.9mL/m2, p = 0.42) between INHD and CHD groups. Over 52weeks, EATindex and PAT indexdid not change significantly in INHD and CHD groups (p = 0.21 and 0.14, respectively), and the changes in EATindex and PATindex did not differ significantly between INHD and CHD groups (p = 0.30 and 0.16, respectively). Overall, changes in EAT indexinversely correlated with changes in LV end-systolic volume index (LVESVI) but not LV end-diastolic volume index (LVEDVI), LV mass index (LVMI), and LV ejection fraction (LVEF). Changes in PATindex inversely correlated with changes in LVESVI, LVMI and positively correlated with changes in LVEF. There were no correlations between changes in EAT indexor PAT indexwith changes in albumin, LDL, triglycerides, troponin-I, FGF-23, or NT-proBNP levels over 52weeks (all p > 0.30). INHD was not associated with any changes in EATindex and PATindex over 12months. Changes in EATindex were not significantly associated with changes in markers of LV remodeling, nutrition, myocardial injury, fibrosis, volume status. In contrast, changes in PATindex, which paradoxically is expected to exert less paracrine effect on the myocardium, were correlated with changes in LVESVI, LVMI and LVEF. Larger and longer-term studies may clarify the role of PAT in cardiac remodeling with intensified hemodialysis. CLINICALTRIALS. NCT00718848.

Effect of High-Cutoff Hemodialysis vs Conventional Hemodialysis on Hemodialysis Independence Among Patients With Myeloma Cast Nephropathy

Cast nephropathy is the main cause of acute kidney injury in multiple myeloma and persistent reduction in kidney function strongly affects prognosis. Strategies to rapidly remove nephrotoxic serum-free light chains combined with novel antimyeloma agents have not been evaluated prospectively. To compare the hemodialysis independence rate among patients newly diagnosed with myeloma cast nephropathy treated with hemodialysis using a high-cutoff dialyzer (with very large membrane pores and high permeability to immunoglobulin light chains) or a conventional high-flux dialyzer (with small pores and lower permeability). Randomized clinical trial involving 98 patients with biopsy-proven myeloma cast nephropathy requiring hemodialysis treated at 48 French centers between July 2011 and June 2016; the final date of follow-up was June 29, 2016. Intensive hemodialysis (eight 5-hour sessions over 10 days) with either a high-cutoff dialyzer (46 patients) or a conventional high-flux dialyzer (48 patients). All patients received the same chemotherapy regimen of bortezomib and dexamethasone. Primary end point was hemodialysis independence at 3 months; secondary end points: hemodialysis independence rates at 6 and 12 months, hemodialysis- and chemotherapy-related adverse events, and death. Among 98 randomized patients, 94 (96%) (median age, 68.8 years [interquartile range, 61.2-75.3 years]; 45% women) were included in the modified intent-to-treat analysis. The hemodialysis independence rate at 3 months was 41.3% (n = 19) in the high-cutoff hemodialysis group vs 33.3% (n = 16) in the conventional hemodialysis group (between-group difference, 8.0% [95% CI, -12.0% to 27.9%], P = .42); at 6 months, the rate was 56.5% (n = 26) vs 35.4% (n = 17), respectively (between-group difference, 21.1% [95% CI, 0.9% to 41.3%], P = .04); and at 12 months, the rate was 60.9% (n = 28) vs 37.5% (n = 18) (between-group difference, 23.4% [95% CI, 3.2% to 43.5%], P = .02). The incidence of hemodialysis-related adverse events was 43% in the high-cutoff hemodialysis group vs 39% in the conventional hemodialysis group; chemotherapy-related serious adverse events, 39% vs 37%, respectively; and at 12 months, 9 patients vs 10 patients died. Among patients with myeloma cast nephropathy treated with a bortezomib-based chemotherapy regimen, the use of high-cutoff hemodialysis compared with conventional hemodialysis did not result in a statistically significant difference in hemodialysis independence at 3 months. However, the study may have been underpowered to identify an early clinically important difference. clinicaltrials.gov Identifier: NCT01208818.

Effect of Nocturnal Hemodialysis versus Conventional Hemodialysis on End-Stage Renal Disease: A Meta-Analysis and Systematic Review.

ObjectivesThe purpose of this study is to assess the efficacy and safety of nocturnal hemodialysis on end-stage renal disease (ESRD) patients.MethodsWe searched Medline, EmBase, and the Cochrance Central Register of Controlled Trials for studies up to January 2016. Analysis was done to compare variant outcomes of different hemodialysis schedules, including mortality, cardiovascular-associated variables, uremia-associated variables, quality of life (QOL), side-effects, and drug usage.ResultsWe collected and analyzed the results of 28 studies involving 22,508 patients in our meta-analysis. The mortality results in this meta-analysis indicated that the nocturnal hemodialysis (NHD) group was not significantly different from conventional hemodialysis (CHD) group (Mortality: OR: 0.75; 95% confidence intervals (CIs): 0.52 to 1.10; p = 0.145), but the CHD group had significantly fewer number of hospitalizations than the NHD group (OR: 1.54; 95%CI: 1.32 to 1.79; p<0.001). NHD was superior to CHD for cardiovascular-associated (left ventricular hypertrophy [LVH]: SMD: -0.39; 95%CI: -0.68 to -0.10; p = 0.009, left ventricular hypertrophy index [LVHI]: SMD: -0.64; 95%CI: -0.83 to -0.46; p<0.001) and uremia-associated intervention results (Serum albumin: SMD: 0.89; 95%CI: 0.41 to 1.36; p<0.001). For the assessment of quality of life, NHD treatment significantly improved the patients’ QOL only for SF36-Physical Components Summary (SMD: 0.43; 95%CI: 0.26 to 0.60; p<0.001). NHD intervention was relatively better than CHD for anti-hypertensive drug usage (SMD: -0.48; 95%CI: -0.91 to -0.05; p = 0.005), and there was no difference between groups in our side-effects assessment.ConclusionNHD and CHD performed similarly in terms of ESRD patients’ mortality and side-effects. NHD was superior to CHD for cardiovascular-associated and uremia-associated results, QOL, and drug usage; for number of hospitalizations, CHD was relatively better than NHD.

Treatment frequency and mortality among incident hemodialysis patients in the United States comparing incremental with standard and more frequent dialysis

Most patients with end-stage renal disease in the United States are initiated on thrice-weekly hemodialysis (HD) regimens. However, an incremental approach to HD may provide several patient benefits. We tested whether initiation of incremental HD does or does not compromise survival compared with a conventional HD regimen. The survival of 434 incremental, 50,162 conventional, and 160 frequent HD patients were compared using Cox regression analysis after matching for demographic and comorbid factors in a longitudinal national cohort of adult incident HD patients enrolled between January 2007 and December 2011. Sensitivity analysis included adjustment for residual kidney function. After adjustment for residual kidney function, all-cause mortality was not significantly different in the incremental compared with conventional HD group (hazard ratio 0.88, 95% confidence interval 0.72-1.08), but was higher in the frequent compared with the conventional HD group (hazard ratio, 1.56, 95% confidence interval 1.21-2.03). The comorbidity burden modified the association of treatment frequency and mortality, with higher comorbidity associated with higher mortality in the incremental HD group (hazard ratio, 1.77, 95% confidence interval 1.20-2.62) for a Charlson Comorbidity Index of≥5. Thus, among incident HD patients with low or moderate comorbid disease, survival was similar for patients initiated on an incremental or conventional HD regimen. Clinical trials are needed to examine the safety and effectiveness of incremental HD and the selected patient populations who may benefit from an incremental approach to HDs initiation.

Menstrual Disturbances in Premenopausal Women with End-Stage Renal Disease: A Cross-Sectional Study

Objective: To evaluate menstrual disturbances and sex hormonal status in premenopausal women with end-stage renal disease (ESRD). Subjects and Methods: The study consisted of 184 patients with ESRD treated with one of four treatment modalities (46/modality): conventional hemodialysis (CHD), continuous ambulatory peritoneal dialysis (CAPD), nocturnal hemodialysis (NHD) and renal transplantation (RT). Blood samples were collected to determine sex hormone levels. Sociodemographic and clinical data were collected from medical records. A questionnaire was administered to analyze menstrual patterns, and the final analysis included 46, 43, 40 and 36 patients in the CHD, CAPD, NHD and RT groups, respectively. Results: The overall prevalence of menstrual disturbances was 64.2% for all four treatment modalities (RT: 50%; NHD: 55%; CAPD: 72.1%, and CHD: 76.1%). Serum prolactin levels were significantly lower (p < 0.01) in the NHD (25.1 ± 10.9 ng/ml) and RT (13.4 ± 5.1 ng/ml) groups than in the CHD group (55.2 ± 10.8 ng/ml). Serum progesterone levels were significantly higher (p < 0.01) in the NHD (25.7 ± 8.3 nmol/l) and RT (30.1 ± 5.9 nmol/l) groups than in the CHD group (17.7 ± 7.3 nmol/l). Moreover, the hormonal status (follicle-stimulating hormone, luteinizing hormone and testosterone) was much closer to normal in the NHD and RT groups compared to the other two groups. Conclusions: In this study, successful transplantation and NHD partially improved the symptoms of menstrual disturbances. Therefore, we recommend that further studies are necessary to confirm our finding in ESRD patients.

Circulating Endotoxaemia and Frequent Haemodialysis Schedules

Background/Aims: Endotoxaemia, a driver of systemic inflammation, appears to be driven by dialysis-induced circulatory stress in haemodialysis (HD) patients. More frequent HD regimens are associated with lower ultrafiltration requirements, improved haemodynamic stability and lower systemic inflammation. This study investigated the hypothesis that more frequently dialysed patients, with reduced exposure to dialysis-induced haemodynamic perturbation, would have lower circulating endotoxin (ET) levels. Methods: A cross-sectional study of 86 established HD patients compared three groups: conventional HD 3× per week (HD3, n = 56), frequent HD 5-6× per week (SDHD, n = 20), and nocturnal HD (NHD, n = 10). Data collection included ultrafiltration volume and rate, serial blood pressures and blood sampling with quantification of ET, troponin T and high-sensitivity CRP (hsCRP). Results: Pre-dialysis serum ET was highest in the conventional HD group (HD3 0.66 ± 0.29 EU/ml vs. NHD 0.08 ± 0.04 EU/ml). Across the study population, severity of endotoxaemia was associated with higher ultrafiltration rates, degree of intradialytic hypotension, troponin T and hsCRP levels. NHD patients had the lowest ultrafiltration requirements, the greatest haemodynamic stability and lower ET levels. Conclusion: More frequent HD regimens are associated with lower levels of circulating ET compared with conventional HD. Reduced ET translocation may be related to the greater haemodynamic stability of these treatments, with superior maintenance of splanchnic perfusion.

Effect of Nocturnal Haemodialysis on Body Composition

Background: Haemodialysis patients have a high risk of malnutrition which is associated with increased mortality. Nocturnal haemodialysis (NHD) is associated with a significant increase in protein intake compared with conventional haemodialysis (CHD). It is unclear whether this leads to improved nutritional status. Therefore, we studied whether 1 year of NHD is associated with a change in body composition. Methods: Whole-body composition using dual-energy X-ray absorptiometry (DEXA) and normalised protein catabolic rate (nPCR) were measured in 11 adult patients before and 1 year after the transition from CHD (12 h dialysis/week) to NHD (28-48 h dialysis/week). Similar measurements were performed in a matched control group of 13 patients who stayed on CHD. Differences between groups were analysed with linear mixed models. Results: At baseline, nPCR, total mass, fat-free mass, and fat mass did not differ significantly between the CHD and NHD groups. nPCR increased in the NHD group (from 0.96 ± 0.23 to 1.12 ± 0.20 g/kg/day; p = 0.027) whereas it was stable in the CHD group (0.93 ± 0.21 at baseline and 0.87 ± 0.09 g/kg/day at 1 year, n.s.). The change in nPCR differed significantly between the two groups (p = 0.027). We observed no significant differences in the course of total mass, fat-free mass, and fat mass during the 1-year observation period between the NHD and CHD groups. Conclusions: One year of NHD had no significant effect on body composition in comparison with CHD, despite a significantly higher protein intake in patients on NHD.

Effect of alternate night nocturnal home hemodialysis on anemia control in patients with end‐stage renal disease

Nocturnal home hemodialysis (NHHD) has shown promising results in various clinical parameters. Whether NHHD provide benefit in anemia management remains controversial. This study aims to investigate whether anemia and erythropoiesis-stimulating agent (ESA) requirement are improved in patients receiving alternate night NHHD compared with conventional hemodialysis (CHD). In this retrospective controlled study, a clinical data of 23 patients receiving NHHD were compared with 25 in-center CHD patients. Hemoglobin level, ESA requirement, iron profile, and dialysis adequacy indexes were compared between the two groups. Hemoglobin level increased from baseline of 9.37 ± 1.39 g/dL to 11.34 ± 2.41 g/dL at 24 months (P < 0.001) and ESA requirement decreased from 103.44 ± 53.55 U/kg/week to 47.33 ± 50.62 U/kg/week (P < 0.001) in NHHD patients. ESA requirement further reduced after the first year of NHHD (P = 0.037). Standard Kt/V increased from baseline of 2.02 ± 0.28 to 3.52 ± 0.30 at 24 months (P < 0.001). At 24 months, hemoglobin level increased by 1.98 ± 2.74 g/dL in the NHHD group while it decreased by 0.20 ± 2.32 g/dL in the CHD group (P = 0.007). ESA requirement decreased by 53.49 ± 55.50 U/kg/week in NHHD patients whereas it increased by 16.22 ± 50.01 U/kg/week in CHD patients (P < 0.001). Twenty-six percent of NHHD patients were able to stop ESA compared with none in the CHD group. Standard Kt/V showed greater increase in the NHHD group. (1.49 ± 0.36 in NHHD vs. 0.18 ± 0.31 in CHD, P = 0.005). NHHD with an alternate night schedule improves anemia and reduces ESA requirement as a result of enhanced uremic clearance. This benefit extended beyond the first year of NHHD.

Effects of Three Times Weekly Eight-Hour Nocturnal Hemodialysis on Volume and Nutritional Status

Background: This prospective cohort study compared the changes in body water composition and nutritional parameters measured with multifrequency bioimpedance analysis between 8-hour three times weekly nocturnal hemodialysis (NHD) and 4-hour conventional hemodialysis (CHD) patients. Patients and Methods: 55 patients on CHD and 57 patients on NHD were included in the study. Multifrequency bioimpedance analysis was performed at baseline and at the 12th month. The primary outcomes of the study were changes in extracellular water (ECW), fat mass, dry lean mass and phase angle. Secondary outcomes of the study included changes in blood pressure and biochemical parameters related to nutrition and inflammation. Results: ECW/height values decreased in the NHD group, while they increased in the CHD group. Fat mass, dry lean mass, and serum albumin increased and high sensitive CRP decreased in the NHD group but did not change in the CHD group. When changes in parameters from baseline to the 12th month between the groups were compared, NHD was associated with improvement in volume parameter including ECW/height (difference -0.44 l/m, p < 0.001). Change in blood pressure was not different between the groups, however requirement for antihypertensive medication decreased from 26.5 to 8.5% in the NHD group (p = 0.002). NHD was also associated with increases in fat mass (difference 1.8 kg, p < 0.001), dry lean mass (difference 0.6 kg, p = 0.006), serum albumin (difference 0.19 g/dl, p < 0.001) and cholesterol (difference 18.8 mg, p < 0.001). Phase angle values decreased in the CHD group but did not change in the NHD group (difference between the groups 0.37°, p = 0.04). Conclusion: This study revealed that longer HD facilitates volume control and improves nutritional status.