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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 and Aims Patient safety is considered of paramount importance under any qualified provision of care, but results from routine tracking of incidents have scarcely been reported, even when that may negatively impact survival. To analyze all types of incidents in a multinational renal service provider network from Jan.1st to Sept. 30th, 2019. Method For the last 10 years, our institution has tracked all incidents under a structured process program, as well as, educated our staff in the importance of proactively reporting and analyzing incidents in a quarterly basis at the clinic, by country and globally. Incidents are categorized in 4 different types: A-Patient related; B-Staff and visitors; C-Products and D-Equipment. Different incident codes are assigned to each type. Results A total of 68.399 incidents (2.7 incidents/patient/year) have been reported during Q1-Q3 2019 (higher than in 2018: 2.2). This means an increase of 20% in the total number of reported incidents. Total incidents/1000 treatments was 17.1 (12.1 patient-related incidents). Reporting follows a heterogeneous pattern among countries, being lowest in Argentina and highest in the UK. Top 5 reported incidents were as follows: Codes A15 (voluntarily shortened treatment) and A14 (Patient did not show up), both related to patient adherence to treatment, accounted for 36% of total incidents, vascular access (VA) complications (A4) for 10.5%, change of dialyzer and/or blood lines due to clotting (A2) for 8.6% and recurrent minor monitor malfunction (D1) for 6.7% of incidents. Codes related with unexpected death or cardiorespiratory arrest are not present among the total global top 10 incidents. Conclusion Detailed tracking of incidents and comparison between countries have potential to increase quality of care. Room for improvement recently made the Corporate Medical Office to launch new strategies on VA management, anticoagulation and patient compliance, among others. This large series may help other institutions to better monitor and standardize patient safety.

Background and Aims Peritoneal dialysis (PD) practice is not universally homogeneous, best clinical practices are not completely understood as reference values are often obtained from small sized populations and/or frequently based on chronic kidney disease (CKD) and/or hemodialysis data. To evaluate two years of follow up of compliance with PD-related quality indicators (QIs) following definition of new targets in an international PD network. Method All English and Spanish language CKD and PD guidelines were reviewed. Twelve Qis were considered being of significant relevance and targets for these QIs were defined (see table). Retrospective data analysis. Results Achievement of QI targets for years 2017-2018 is shown in table. Variability among countries not shown. Conclusion There was a significant increase in QIs achievement in 2018 vs. 2017. ≥75% of patients met the target for the following variables: total weekly Kt/Vurea, 24 h fluid removal, mean arterial blood pressure and serum albumin. Peritonitis rates are clearly over International objectives and were improving. Due to the lack of referral source data, these series may help to understand PD practice and outcomes in a global setting.

Background and Aims Decision-Making Tools (DMTs) are still not widely used but are considered the Gold Standard to ensure patients are well informed to choose renal replacement therapy (RRT) modality. To analyze the impact of a structured modality information program (via DMTs) on RRT modality choice and start. Method All 2014-2017 predialysis patients (pts) with CKD G4-G5 and those starting unplanned dialysis without a prior information process underwent a DMTs process for RRT choice and were followed up to Dec.31st, 2018. DMTs included values evaluation, RRT information with different tools, staff deliberation support and patient modality choice. Results shown as percentage of pts who reached a certain stage over the total number of pts under evaluation. Results 2012 pts (mean age 61 y.) from 48 clinics (cl.) in Poland (PL, 19 cl., 980 pts), Romania (RO, 12 cl., 351 pts), Hungary (HU, 10 cl., 341 pts), Germany (DE, 6 cl., 292 pts) and Argentina (AR, 1 cl., 48 pts) underwent DMTs. Staff considered PD contraindicated in 29% of pts, hence optimal candidates for HD/PD were 1408 pts. (mean age 60y. and 46% prone for a home therapy). Early referral (≥3 m. in clinic before DMT started): 51%. Aids used included written information (97% of pts), DVD in 27% and HD/PD utility visits in 49%. Relatives’ participation in the process was 82%. Most pts (91%) considered the program useful whilst 64% of staff felt that this program was better than the prior one. PD choice (35%) varied among countries: 15% (RO), 30% (PL), 36% (HU), 62% (DE) and 98% (AR). For pts who had started dialysis by study closure (n=948), PD as chronic RRT was 31% (9% after an unplanned HD start); 13% (RO), 27% (PL), 34% (HU), 54% (GE) and 83% (AR). Conclusion Use of DMTs at the time of RRT modality choice complies with patient empowerment and decision sharing (patients-relatives-staff). PD choice and take-on varied among countries. Most patients who chose PD were chronically ascribed to PD representing at least one third of the suitable patients for both dialysis modalities.

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