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Background and Aims Although high-dose haemodiafiltration (HDF) has shown some promising survival advantage compared with high-flux haemodialysis (HD), the evidence remains controversial. In view of these discrepant results, a definitive trial is required to determine whether high-dose HDF is superior to high-flux HD. The comparison of high-dose HDF with high-flux HD (CONVINCE) study will assess the benefits and harms of high-dose HDF versus conventional high-flux HD in adults with end-stage kidney disease (ESKD). Here we provide information on the baseline characteristics of the included patients and evaluate whether the patients randomised to HDF were able to reach a high-dose convection volume. Method This international, prospective, open label, randomised, controlled trial is aiming to recruit 1800 ESKD adults treated with high-flux HD in 9 European countries. Patients will be randomised 1:1 to high-dose HDF versus continuation of conventional high-flux HD. High-dose HDF is defined as a convection volume per session of ≥23 L (range ±1 L). The trial is designed with a follow-up time for each patient of at least 24 months and will assess all-cause mortality, cause-specific mortality, cardiovascular events, hospitalisation, patient-reported outcomes, and cost-effectiveness. For this study we tabulated the baseline characteristics for all randomised participants by treatment groups. For the patients randomised to HDF, we calculated the proportion of the patients reaching a convection volume of ≥ 23L. session on the first visit after baseline (i.e. 3 months) and compared baseline and treatment characteristics with the patients with a convection volume of Results CONVINCE has recruited, until the start of January 2021, 1139 patients in eight European countries. The mean age was 62.4 (SD: 13.2) years and 62% (n=709) patients were men. The mean dialysis vintage was 5.0 (6.1) years. The mean systolic blood pressure (BP) was 141 (22) mmHg, the diastolic BP was 73 (14) mmHg, and the body mass index (BMI) was 27.6 (5.7) kg/m2. Approximately one-third the patients had diabetes mellitus and 21% had a history of coronary heart disease at baseline. Of the patients randomised to HDF, over 85% achieved a convection volume of ≥23L/session. There were no apparent differences in baseline and treatment characteristics between the patients who reached a convective volume of ≥23L/session versus those who did not: the vascular access was, respectively, a fistula (82% vs 81%), catheter (13% vs 14%), and graft (5% vs 5%) access. Conclusion The CONVINCE study will run up to 2023 and addresses the question of benefits and harms, regarding survival, hospitalisation, patient-reported outcomes, and cost-effectiveness of high-dose HDF compared with high-flux HD in patients with ESKD. This first analysis shows that achievement of high-dose HDF is feasible for most patients and, most importantly, could be maintained during the present trial period.

Background and Aims Patient safety programs need a well-structured organization to facilitate proactive and fair reporting, prompt evaluation analysis and timely feedback followed by measure implementation and auditing. To analyze all types of incidents in our network from Jan.1st to Sept. 30th, 2019 by two different levels (Corporate and Country) of medical management alert. Method Our institution has tracked all incidents under a structured process program for the last 10 years, according to 4 incident types (Patient related, Staff-visitors, Products and Equipment) and 54 subcodes. Incidents are considered as serious when they may be life-threatening or result in death, impaired body function/structure and/or are deemed serious based on appropriate medical judgment. Communication to Health Authorities applies in accordance with local country regulations. “Serious incidents” are immediately notified to the Corporate Office and to each Country Medical lead, whilst different codes may generate alerts into Corporate or Country. Results A total of 68.399 incidents (2.7 incident/patient/year) were reported during Q1-Q3 2019. Total incidents/1000 treatments were 17.1 (12.1 were patients related incidents). Causes for alerts at corporate level (n=65) were: cardiorespiratory arrest (28%); unexpected death (15%); seroconversion (9%); hemolysis (8%), severe hypotension (6%) and air embolism (3%). Reported incidents at country level (n=655) were almost half ascribed to equipment [water supply, power failure and flooding (41%)], medication errors (36%), venous needle dislodgment (19%) and Injuries (3%). Conclusion Despite continuous efforts to get better results, there is room for improvement on better staff compliance with our standard operating procedures especially regarding medications and venous needle dislodgment risk assessment.

Background and Aims With the exception of some national registries, data referred to mortality or hospitalization within a single large international peritoneal dialysis (PD) institution are seldom reported. To study all-cause mortality, transplantation rate, hospitalizations and peritonitis rates in our large PD program during 2018. Method Observational, prospective registry in 8 countries. The following variables were tracked: crude mortality rate and causes, hospitalization variables (nº of hospitalization days per patient; nº of hospitalization episodes per patient; nº of days per hospitalization episode; causes of hospitalization), peritonitis rate (episodes/year at risk and patient months at risk to a peritonitis episode) and transplantation rate. Results By the end of December 2018, 1207 pt. were treated (11 countries) but only 8 countries submitted data. Evaluated population as “patients treated at risk during the year”: AR (319.5), RO (173.5), DE (137), HU (103), PL (97), UR (69.5), CL (27), KZ (7). Crude mortality rate was 13.1%, same if first 90 days on therapy were excluded. Lowest mortality was seen in HU (9.9%) and highest in DE (19.3%). Causes of death: cardiac 32%, all type infections 22% [Sepsis 78%, PD related 11% (as 0.7% of total mortality), pulmonary 3.7%, others 7.4%], vascular 10%, gastrointestinal 3.3%, unknown 10.7% (highest in DE, 23%), other known causes 21.5%. Hospitalization rates: 0.55 episodes/per patient-year and 7.6 days of hospitalization per patient-year. Nº of days per hospitalization episode was 13.7. Causes of hospitalization: PD related 38%, cardiovascular 17%, non-PD infection sepsis 10.7% (higher in LA, 16.6%), vascular access 2.1%, unknown 4.5%, others 23.3%. Global peritonitis rate was 0.18 episodes/pt-year at risk (1 episode every 66 m.). However, large differences were seen among countries. Transplantation rate was 6.5% (much higher in UR). PD was withdrawal in 35% of pt. Country specific data have been evaluated but are not shown here. Conclusion The use of a common registry in our institution increases quality and allows homogeneous comparisons across countries that if promptly addressed may increase patients’ outcomes. Our series may bring light into the PD community as one of the ever largest tracked in a single institution.

Background Periodontitis is associated with cardiovascular mortality in the general population and adults with chronic diseases. However, it is unclear whether periodontitis predicts survival in the setting of kidney failure. Methods ORAL-D was a propensity matched analysis in 3338 dentate adults with end-stage kidney disease treated in a hemodialysis network in Europe and South America designed to examine the association between periodontitis and all-cause and cardiovascular-related mortality in people on long-term hemodialysis. Participants were matched 1:1 on their propensity score for moderate to severe periodontitis assessed using the World Health Organization Community Periodontal Index. A random-effects Cox proportional hazards model was fitted with shared frailty to account for clustering of mortality risk within countries. Results Among the 3338 dentate participants, 1355 (40.6%) had moderate to severe periodontitis at baseline. After using propensity score methods to generate a matched cohort of participants with periodontitis similar to those with none or mild periodontal disease, moderate to severe periodontitis was associated with a lower risk of all-cause (9.1 versus 13.0 per 100 person years, hazard ratio 0.74, 95% confidence interval 0.61 to 0.90) and cardiovascular (4.3 versus 6.9 per 100 person years, hazard ratio 0.67, 0.51 to 0.88) mortality. These associations were not changed substantially when participants were limited to those with 12 or more natural teeth and when accounting for competing causes of cardiovascular death. Conclusion In contrast to the general population, periodontitis does not appear to be associated with an increased risk of early death in adults treated with hemodialysis. Electronic supplementary material The online version of this article (doi:10.1186/s12882-017-0574-x) contains supplementary material, which is available to authorized users.

Sexual dysfunction may affect 80% of women in hemodialysis. However the specific patterns and clinical correlates of sexual functioning remain poorly described. The aim of this study was to assess prevalence and correlates of the individual domains of sexual functioning in women treated with hemodialysis. We recruited, into this multinational cross-sectional study, women treated with long-term hemodialysis (Collaborative Working Group on Depression and Sexual dysfunction in Hemodialysis study). Self-reported domains of sexual functioning were assessed by the Female Sexual Function Index, which is routinely administered within the network of dialysis patients followed by the working group. Lower scores represented lower sexual functioning. Socio-demographic and clinical correlates of each domain of sexual functioning were identified by stepwise multivariable linear regression. Sensitivity analyses were restricted to women who reported being sexually active. We found that of 1309 enrolled women, 659 (50.3%) provided complete responses to FSFI survey questions and 232 (35%) reported being sexually active. Overall, most respondents reported either no sexual activity or low sexual functioning in all measured domains (orgasm 75.1%; arousal 64.0%; lubrication 63.3%; pain 60.7%; satisfaction 60.1%; sexual desire 58.0%). Respondents who were waitlisted for a kidney transplant reported scores with higher sexual functioning, while older respondents reported scores with lower functioning. The presence of depression was associated with worse lubrication and pain scores [mean difference for depressed versus non-depressed women (95% CI) -0.42 (-0.73 to -0.11), -0.53 (-0.89 to -0.16), respectively] while women who had experienced a previous cardiovascular event reported higher pain scores [-0.77 (-1.40- to -0.13)]. In conclusion, women in hemodialysis reported scores consistent with marked low sexual functioning across a range of domains; the low functioning appeared to be associated with comorbidity.

Background: Sexual dysfunction is an under-recognized problem in men and women with chronic kidney disease (CKD). The prevalence, correlates, and predictors of this condition in patients with CKD have not been evaluated comprehensively. Study Design: Systematic review and meta-analysis. Setting & Population: Patients treated using dialysis (dialysis patients), patients treated using transplant (transplant recipients), and patients with CKD not treated using dialysis or transplant (nondialysis nontransplant patients with CKD). Selection Criteria for Studies: Observational studies conducted in patients with CKD only or including a control group without CKD. Predictor: Type of study population. Outcomes: Sexual dysfunction in men and women with CKD using validated tools, such as the International Index of Erectile Function, the Female Sexual Function Index (FSFI), or other measures as reported by study investigators. Results: 50 studies (8,343 patients) of variable size (range, 16-1,023 patients) were included in this review. Almost all studies explored sexual dysfunction in men and specifically erectile dysfunction. The summary estimate of erectile dysfunction in men with CKD was 70% (95% CI, 62%-77%; 21 studies, 4,389 patients). Differences in reported prevalence rates of erectile dysfunction between different studies were attributable primarily to age, study populations, and type of study tool used to assess the presence of erectile dysfunction. In women, the reported prevalence of sexual dysfunction was assessed in only 306 patients from 2 studies and ranged from 30%-80%. Compared with the general population, women with CKD had a significantly lower overall FSFI score (8 studies or subgroups, 407 patients; mean difference, 9.28; 95% CI, 12.92 to 5.64). Increasing age, diabetes mellitus, and depression consistently were found to correlate with sexual dysfunction in 20 individual studies of patients with CKD using different methods. Limitations: Suboptimal and lack of uniform assessment of outcome measures. Conclusions: Sexual dysfunction is highly prevalent in both men and women with CKD, especially among those on dialysis. Larger studies enrolling different ethnic groups, using validated

Background Oral disease is a potentially treatable determinant of mortality and quality of life. No comprehensive multinational study to quantify oral disease burden and to identify candidate preventative strategies has been performed in the dialysis setting. Methods The ORAL disease in hemoDialysis (ORALD) study was a prospective study in adults treated with hemodialysis in Europe (France, Hungary, Italy, Poland, Portugal and Spain) and Argentina. Oral disease was assessed using standardized WHO methods. Participants self-reported oral health practices and symptoms. Sociodemographic and clinical factors associated with oral diseases were determined and assessed within nation states. Results Of 4726 eligible adults, 4205 (88.9%) participated. Overall, 20.6% were edentulous [95% confidence interval (CI), 19.4-21.8]. Participants had on average 22 (95% CI 21.7-22.2) decayed, missing or filled teeth, while moderate to severe periodontitis affected 40.6% (95% CI 38.9-42.3). Oral disease patterns varied markedly across countries, independent of participant demographics, comorbidity and health practices. Participants in Spain, Poland, Italy and Hungary had the highest mean adjusted odds of edentulousness (2.31, 1.90, 1.90 and 1.54, respectively), while those in Poland, Hungary, Spain and Argentina had the highest odds of ≥14 decayed, missing or filled teeth (23.2, 12.5, 8.14 and 5.23, respectively). Compared with Argentina, adjusted odds ratios for periodontitis were 58.8, 58.3, 27.7, 12.1 and 6.30 for Portugal, Italy, Hungary, France and Poland, respectively. National levels of tobacco consumption, diabetes and child poverty were associated with edentulousness within countries. Conclusions Oral disease in adults on hemodialysis is very common, frequently severe and highly variable among countries, with much of the variability unexplained by participant characteristics or healthcare. Given the national variation and high burden of disease, strategies to improve oral health in hemodialysis patients will require implementation at a country level rather than at the level of individuals.

Background Dental disease is more extensive in adults with chronic kidney disease, but whether dental health and behaviors are associated with survival in the setting of hemodialysis is unknown. Study Design Prospective multinational cohort. Setting & Participants 4,205 adults treated with long-term hemodialysis, 2010 to 2012 (Oral Diseases in Hemodialysis [ORAL-D] Study). Predictors Dental health as assessed by a standardized dental examination using World Health Organization guidelines and personal oral care, including edentulousness; decayed, missing, and filled teeth index; teeth brushing and flossing; and dental health consultation. Outcomes All-cause and cardiovascular mortality at 12 months after dental assessment. Measurements Multivariable-adjusted Cox proportional hazards regression models fitted with shared frailty to account for clustering of mortality risk within countries. Results During a mean follow-up of 22.1 months, 942 deaths occurred, including 477 cardiovascular deaths. Edentulousness (adjusted HR, 1.29; 95% CI, 1.10-1.51) and decayed, missing, or filled teeth score ≥ 14 (adjusted HR, 1.70; 95% CI, 1.33-2.17) were associated with early all-cause mortality, while dental flossing, using mouthwash, brushing teeth daily, spending at least 2 minutes on oral hygiene daily, changing a toothbrush at least every 3 months, and visiting a dentist within the past 6 months (adjusted HRs of 0.52 [95% CI, 0.32-0.85], 0.79 [95% CI, 0.64-0.97], 0.76 [95% CI, 0.58-0.99], 0.84 [95% CI, 0.71-0.99], 0.79 [95% CI, 0.65-0.95], and 0.79 [95% CI, 0.65-0.96], respectively) were associated with better survival. Results for cardiovascular mortality were similar. Limitations Convenience sample of clinics. Conclusions In adults treated with hemodialysis, poorer dental health was associated with early death, whereas preventive dental health practices were associated with longer survival.

Background. The diagnosis of analgesic nephropathy has improved significantly with modern imaging techniques. We reviewed a large portion of the Hungarian dialysis population to obtain additional insight into the problem. Methods. Twenty-two participating dialysis units enrolled 1400 patients on renal replacement therapy between 1 January 1995 and 1 January 1998. Patients with no known aetiology (n ¼ 284) were interviewed and studied with renal imaging. We assessed the presence of decreased renal mass combined with either bumpy contours, papillary calcification, or both. The subjects studied were interrogated extensively. Results. Our survey suggested analgesic nephropathy in 47 of 1400 patients (3.3%), 3-fold higher than the EDTA database estimate for Hungary. The analgesics most commonly abused were phenacetin-containing mixtures. The driving symptoms were mainly headache and joint pain. Cardiovascular complications were more common than in the rest of the dialysis population, independent of smoking and lipid values (P

Objectives To evaluate patient experiences of specific aspects of haemodialysis care across several countries. Design Cross-sectional survey using the Choices for Healthy Outcomes in Caring for End-Stage Renal Disease (CHOICE) questionnaire. Setting Haemodialysis clinics within a single provider in Europe and South America. Participants 2748 adults treated in haemodialysis. Primary and secondary outcomes The primary outcome was patient satisfaction with overall care. Secondary outcomes included patient experiences of individual aspects of dialysis care. Results 2145 (78.1%) adults responded to the questionnaire. Fewer than half (46.5% (95% CI 44.5% to 48.6%)) rated their overall care as excellent. Global perceptions of care were uninfluenced by most respondent characteristics except age and depressive symptoms; older respondents were less critical of their care (adjusted OR for excellent rating 1.44 (1.01 to 2.04)) and those with depressive symptoms were less satisfied (0.56 (0.44 to 0.71)). Aspects of care that respondents most frequently ranked as excellent were staff attention to dialysis vascular access (54% (52% to 56%)); caring of nurses (53% (51% to 55%)); staff responsiveness to pain or discomfort (51% (49% to 53%)); caring, helpfulness and sensitivity of dialysis staff (50% (48% to 52%)); and ease of reaching dialysis staff by telephone (48% (46% to 50%)). The aspects of care least frequently ranked as excellent were information provided when choosing a dialysis modality (23% (21% to 25%)), ease of seeing a social worker (28% (24% to 32%)), information provided about dialysis (34% (32% to 36%)), accuracy of information from nephrologist (eg, about prognosis or likelihood of a kidney transplant; 37% (35% to 39%)) and accuracy of nephrologists’ instructions (39% (36% to 41%)). Conclusions Haemodialysis patients are least satisfied with the complex aspects of care. Patients’ expectations for accurate information, prognosis, the likelihood of kidney transplantation and their options when choosing dialysis treatment need to be considered when planning healthcare research and practices.

Background Achieving target levels of laboratory parameters of bone and mineral metabolism in chronic kidney disease (CKD) patients is important but also difficult in those living with end-stage kidney disease. This study aimed to determine if there are age-related differences in chronic kidney disease-mineral and bone disorder (CKD-MBD) characteristics, including treatment practice in Hungarian dialysis patients. Methods Data were collected retrospectively from a large cohort of dialysis patients in Hungary. Patients on hemodialysis and peritoneal dialysis were also included. The enrolled patients were allocated into two groups based on their age (

Introduction Integrated Care Settings (ICS) provide a holistic approach to the transition from chronic kidney disease into renal replacement therapy (RRT), offering at least both types of dialysis. Objectives To analyze which factors determine type of referral, modality provision and dialysis start on final RRT in ICS clinics. Methods Retrospective analysis of 626 patients starting dialysis in 25 ICS clinics in Poland, Hungary and Romania during 2012. Scheduled initiation of dialysis with a permanent access was considered as planned RRT start. Results Modality information (80% of patients) and renal education (87%) were more frequent (p8.2 ml/min, >2 months between information and RRT initiation and with vascular etiology after adjustment for age and gender. “Optimal care,” defined as ICS follow-up >12 months plus modality information and P start, occurred in 23%. Conclusions Despite the high rate of late referrals, information and education were widely provided. However, NP start was high and related to late referral and may explain the low frequency of PD.

Background People with end-stage kidney disease treated with dialysis experience high rates of premature death that are at least 30-fold that of the general population, and have markedly impaired quality of life. Despite this, interventions that lower risk factors for mortality (including antiplatelet agents, epoetins, lipid lowering, vitamin D compounds, or dialysis dose) have not been shown to improve clinical outcomes for this population. Although mortality outcomes may be improving overall, additional modifiable determinants of health in people treated with dialysis need to be identified and evaluated. Oral disease is highly prevalent in the general population and represents a potential and preventable cause of poor health in dialysis patients. Oral disease may be increased in patients treated with dialysis due to their lower uptake of public dental services, as well as increased malnutrition and inflammation, although available exploratory data are limited by small sample sizes and few studies evaluating links between oral health and clinical outcomes for this group, including mortality and cardiovascular disease. Recent data suggest periodontitis may be associated with mortality in dialysis patients and well-designed, larger studies are now required. Methods/design The ORAL Diseases in hemodialysis (ORAL-D) study is a multinational, prospective (minimum follow-up 12 months) study. Participants comprise consecutive adults treated with long-term in-center hemodialysis. Between July 2010 and February 2012, we recruited 4500 dialysis patients from randomly selected outpatient dialysis clinics in Europe within a collaborative network of dialysis clinics administered by a dialysis provider, Diaverum, in Europe (France, Hungary, Italy, Poland, Portugal, and Spain) and South America (Argentina). At baseline, dental surgeons with training in periodontology systematically assessed the prevalence and characteristics of oral disease (dental, periodontal, mucosal, and salivary) in all participants. Oral hygiene habits and thirst were evaluated using self-administered questionnaires. Data for hospitalizations and mortality (total and cause-specific) according to baseline oral health status will be collected once a year until 2022. Discussion This large study will estimate the prevalence, characteristics and correlations of oral disease and clinical outcomes (mortality and hospitalization) in adults treated with dialysis. We will further evaluate any association between periodontitis and risk of premature death in dialysis patients that has been suggested by existing research. The results from this study should provide powerful new data to guide strategies for future interventional studies for preventative and curative oral disease strategies in adults who have end-stage kidney disease.