Impact of Medium Cut-Off Dialyzers on Patient-Reported Outcomes: COREXH Registry.

INTRODUCTION: A new generation of hemodialysis (HD) membranes called medium cut-off (MCO) membranes possesses enhanced capacities for middle molecule clearance, which have been associated with adverse outcomes in this population. These improvements could potentially positively impact patient-reported outcomes (PROs). OBJECTIVE: The objective of this study was to evaluate the impact of MCO membranes on PROs in a cohort of HD patients in Colombia. METHODS: This was a prospective, multicenter, observational cohort study of 992 patients from 12 renal clinics in Colombia who were switched from high-flux HD to MCO therapy and observed for 12 months. Changes in Kidney Disease Quality of Life 36-Item Short Form Survey (KDQoL-SF36) domains, Dialysis Symptom Index (DSI), and restless legs syndrome (RLS) 12 months after switching to MCO membranes were compared with time on high-flux membranes. Repeated measures of ANOVA were used to evaluate changes in KDQoL-SF36 scores; severity scoring was used to assess DSI changes over time; Cochran's Q test was used to evaluate changes in frequency of diagnostic criteria of RLS. RESULTS: During 12 months of follow-up, 3 of 5 KDQoL-SF36 domains improved compared with baseline: symptoms (p < 0.0001), effects of kidney disease (p < 0.0001), and burden of kidney disease (p < 0.001). The proportion of patients diagnosed with RLS significantly decreased from 22.1% at baseline to 10% at 12 months (p < 0.0001). No significant differences in the number of symptoms (DSI, p = 0.1) were observed, although their severity decreased (p = 0.009). CONCLUSIONS: In conventional HD patients, the expanded clearance of large middle molecules with MCO-HD membranes was associated with higher health-related quality of life scores and a decrease in the prevalence of RLS.

Medium cut-off dialyzers in a large population of hemodialysis patients in Colombia: COREXH registry.

Expanded hemodialysis (HDx) provides increased clearance of conventional and large middle molecules through innovative medium cutoff (MCO) membranes. However, there is a paucity of real-world data regarding the benefits and safety of HDx. This large observational study evaluated outcomes among patients in Colombia undergoing HDx at a extended dialysis clinical services provider. This was a prospective single cohort study of prevalent patients who were treated with HDx; baseline information was collected from the most recent data before patients were started on HDx. Patients were followed prospectively for 1 year for changes in serum albumin and other laboratory parameters compared with the baseline. Survival, hospitalization and safety were assessed from the start of HDx. A total of 1000 patients were invited to enroll; 992 patients met the inclusion criteria for data analysis and 638 patients completed the year of follow-up. Seventy-four (8%) patients died during 866 patient-years (PY) of follow-up; the mortality rate was 8.54 deaths/100 PY (95% confidence interval [CI], 6.8-10.7). There were 673 hospitalization events with a rate of 0.79 events/PY (95% CI, 0.73-0.85) with 6.91 hospital days/PY (95% CI, 6.74-7.09). The observed variability from baseline and maximum average change in mean serum albumin levels were -1.8% and -3.5%, respectively. No adverse events were related to the MCO membrane. HDx using an MCO membrane maintains stable serum albumin levels and is safe in terms of nonoccurrence of dialyzer related adverse events.

Consenso colombiano de expertos sobre recomendaciones informadas en la evidencia para la prevención, el diagnóstico y el manejo de la infección por SARS-CoV-2/COVID-19 en pacientes con Enfermedad Renal Crónica en diálisis / Colombian Expert Consensus on Evidence-Informed Recommendations for the Prevention, Diagnosis, and Management of SARS-CoV-2 / COVID-19 Infection in Patients with Chronic Kidney Disease on Dialysis

Resumen Introducción: Las personas con diálisis de mantenimiento se consideran una población en alto riesgo de infección por SARS-CoV-2, complicaciones y muerte. La periodicidad de la diálisis, la organización y la demanda en las unidades de diálisis y las limitaciones de alfabetización en salud poblacional limitan el cumplimiento del aislamiento y el distanciamiento social. Objetivo: Desarrollar, mediante un consenso de expertos, recomendaciones informadas en evidencia para la prevención, el diagnóstico y el manejo de la infección por SARS-CoV-2/COVID-19 en pacientes con enfermedad renal crónica. Materiales y métodos: Se realizó una revisión rápida de literatura en Pubmed, Embase y sociedades científicas. La calidad de evidencia fue evaluada según el tipo de estudio incluido. El acuerdo se definió para cada recomendación con umbral de al menos 70% de aprobación. La fuerza de las recomendaciones fue graduada como fuerte o débil. Resultados: El colectivo fue consultado entre el 17 y 19 de mayo de 2020. Se obtuvo respuesta de 44 expertos clínicos que declararon conflicto de interés previo a la consulta. El acuerdo de las recomendaciones estuvo entre 70,5 y 100%. Se presentan las recomendaciones de un colectivo experto para la prevención, el diagnóstico y el manejo de infección por SARS-CoV-2/COVID-19 en pacientes con enfermedad renal crónica. Conclusión: Debido a la reciente aparición de la infección por SARS-CoV-2 y las incertidumbres respecto a la prevención, el diagnóstico y el manejo, las recomendaciones presentadas se conciben como un estándar colombiano que permita garantizar un cuidado centrado en las personas con enfermedad renal crónica y la protección de los profesionales de la salud.

Abstract Introduction: People with chronic dialysis are considered a population at high risk of SARS CoV2 infection and its derived complications and death. The need to go to strict dialysis schedules, the high demand in the kidney facilities and the difficulties derived from the time and space organization in the rooms in the face to the pandemic added to the difficult learning, teaching and adapting new protocols manifest the needed of standard recommendation according to this problem in people who couldn't have an ideal isolation. Objective: Develop through an expert consensus, evidence-informed recommendations for the prevention, diagnosis, and management of SARS-CoV-2/COVID-19 infection in patients with chronic kidney disease on Dialysis. Materials and methods: We carried out a quick literature review, PubMed, Embase and scientific societies were consulted. The quality of the evidence was considered according to the type of study included. The agreement threshold defined for each recommendation was > 70% approval among experts. The strength of the recommendations was rated as strong or weak. Results: Between May 17 and 19, 2020, was conformed a team of 44 clinical experts who declared their interest conflict prior to the consultation. The agreement of the recommendations was between 70.5% and 100%. The recommendations were separated in prevention, early identification, and diagnostic, isolation in hemodialysis facilities and peritoneal dialysis, and team protection. Ethical considerations also were included. Conclusion: Due to the recent appearance of SARS-CoV-2 infection and the uncertainties regarding prevention, diagnosis and management, the recommendations presented are conceived as a Colombian standard that allows guaranteeing focused care for people with chronic kidney disease and the protection of health team.

Evaluating a remote patient monitoring program for automated peritoneal dialysis.

BACKGROUND: The benefits of automated peritoneal dialysis (APD) have been established, but patient adherence to treatment remains a concern. Remote patient monitoring (RPM) programs are a potential solution; however, the cost implications are not well established. This study modeled, from the payer perspective, expected net costs and clinical consequences of a novel RPM program in Colombia. METHODS: Amarkov model was used to project costs and clinical outcomes for APD patients with and without RPM. Clinical inputs were directly estimated from Renal Care Services data or taken from the literature. Dialysis costs were estimated from national fees. Inpatient costs were obtained from a recent Colombian study. The model projected overall direct costs and several clinical outcomes. Deterministic and probabilistic sensitivity analyses (DSA and PSA) were also conducted to characterize uncertainty in the results. RESULTS: The model projected that the implementation of an RPM program costing US$35 per month in a cohort of 100 APD patients over 1 year would save US$121,233. The model also projected 31 additional months free of complications, 27 fewer hospitalizations, 518 fewer hospitalization days, and 6 fewer peritonitis episodes. In the DSA, results were most sensitive to hospitalization rates and days of hospitalization, but cost savings were robust. The PSA found there was a 91% chance for the RPM program to be cost saving. CONCLUSION: The results of the model suggest that RPM is cost-effective in APD patients which should be verified by a rigorous prospective cost analysis.

Remote Patient Monitoring Program in Automated Peritoneal Dialysis: Impact on Hospitalizations.

Background:Automated peritoneal dialysis (APD) is a growing PD modality but as with other home dialysis methods, the lack of monitoring of patients' adherence to prescriptions is a limitation with potential negative impact on clinical outcome parameters. Remote patient monitoring (RPM) allowing the clinical team to have access to dialysis data and adjust the treatment may overcome this limitation. The present study sought to determine clinical outcomes associated with RPM use in incident patients on APD therapy.Methods:A retrospective cohort study included 360 patients with a mean age of 57 years (diabetes 42.5%) initiating APD between 1 October 2016 and 30 June 2017 in 28 Baxter Renal Care Services (BRCS) units in Colombia. An RPM program was used in 65 (18%) of the patients (APD-RPM cohort), and 295 (82%) were treated with APD without RPM. Hospitalizations and hospital days were recorded over 1 year. Propensity score matching 1:1, yielding 63 individuals in each group, was used to evaluate the association of RPM exposure with numbers of hospitalizations and hospital days.Results:After propensity score matching, APD therapy with RPM (n = 63) compared with APD-without RPM (n = 63) was associated with significant reductions in hospitalization rate (0.36 fewer hospitalizations per patient-year; incidence rate ratio [IRR] of 0.61 [95% confidence interval (CI) 0.39 - 0.95]; p = 0.029) and hospitalization days (6.57 fewer days per patient-year; IRR 0.46 [95% CI 0.23 - 0.92]; p = 0.028).Conclusions:The use of RPM in APD patients is associated with lower hospitalization rates and fewer hospitalization days; RPM could constitute a tool for improvement of APD therapy.

Impact of a Basal-Bolus Insulin Regimen on Metabolic Control and Risk of Hypoglycemia in Patients With Diabetes Undergoing Peritoneal Dialysis.

INTRODUCTION: Clinical interventional studies in diabetes mellitus usually exclude patients undergoing peritoneal dialysis (PD). This study evaluates the impact of an educational program and a basal-bolus insulin regimen on the blood glucose level control and risk of hypoglycemia in this population. METHODS: A before-and-after study was conducted in type 1 and type 2 DM patients undergoing PD at the Renal Therapy Services (RTS) clinic network, Bogota, Colombia. An intervention was instituted consisting of a three-month educational program and a basal-bolus detemir (Levemir, NovoNordisk) and aspart (Novorapid, NovoNordisk) insulin regimen. Prior to the intervention and at the end of treatment were conducted measures of HbA1c levels and continuous glucose monitoring (CGM). RESULTS: Forty-seven patients were recruited. Mean HbA1c level decreased from 8.41% ± 0.83 to 7.68% ± 1.32 (mean difference -0.739, 95% CI -0.419, -1.059; P < .0001). Of subjects, 52% achieved HbA1c levels <7.5% at the end of study. Mean blood glucose level reduced from 194.0 ± 42.5 to 172.9 ± 31.8 mg/dl ( P = .0015) measured by CGM. Significant differences were not observed in incidence of overall ( P = .7739), diurnal ( P = .3701), or nocturnal ( P = .5724) hypoglycemia episodes nor in area under the curve (AUC) <54 mg/dl ( P = .9528), but a reduction in AUC >180 ( P < .01) and AUC >250 ( P = .01) was evidenced for total, diurnal, and nocturnal episodes. CONCLUSIONS: An intervention consisting of an educational program and a basal-bolus insulin regimen in type 1 and type 2 diabetes mellitus patients undergoing PD caused a decrease in HbA1c levels, and mean blood glucose levels as measured from CGM with no significant increases in hypoglycemia episodes.

Mortalidad observada versus esperada en una red de unidades de diálisis en Colombia / Observed versus expected mortality in a network of dialysis units in Colombia

Resumen Antecedentes: la mortalidad en diálisis es uno de los principales indicadores de gestión clínica y se ve influenciada por diversos factores sociodemográficos y clínicos. Objetivos: calcular la mortalidad observada versus la esperada en las unidades de diálisis de la red de RTS en Colombia. Métodos: cohorte histórica de pacientes mayores de 18 años, prevalentes en diálisis entre el 1 de enero y el 31 de diciembre de 2012, de 51 unidades renales de la red Renal Therapy Services (RTS). Se calculó la razón estandarizada de mortalidad (REM) siguiendo la metodología propuesta por la Universidad de Michigan Centro de Costos y Epidemiologic Renal (UM-KECC); se implementó un modelo de supervivencia de riesgos proporcionales de Cox en dos etapas, la primera estimó los parámetros asociados con las variables explicativas y la segunda estandarizó los resultados. Resultados: se evaluaron 9798 pacientes, 4125 (42.1%) fueron mujeres, la media de edad fue de 59 años (DE=15.6). Se observaron 1253 eventos de muerte (12.7%). El modelo arrojó un valor de 1067 muertes esperadas, con un valor estimado de REM de 1.17 (IC95%: 1.11-1.24). La REM fue mayor para pacientes diabéticos 1.28 (IC95%:1.19-1.38) y mujeres (1.36 (IC95%: 1.25-1.48); y varió significativamente por zona del país (1.11 a 2.0). Conclusiones: encontramos diferencias importantes en la REM según sexo, presencia de diabetes y por zonas del país. Se requiere mediante nuevos estudios entender mejor la influencia de estas y otras variables sobre el fenómeno de mortalidad en diálisis en nuestro contexto. (Acta Med Colomb 2017; 42: 106-111).

Abstract Background: mortality in dialysis is one of the main indicators of clinical management and is influenced by various socio-demographic and clinical factors. Objectives: to calculate the observed versus expected mortality in the dialysis units of the RTS network in Colombia. Methods: a historical cohort of patients older than 18 years, prevalent on dialysis between January 1 and December 31, 2012, of 51 renal units of the Renal Therapy Services (RTS) network. The standardized mortality ratio (SMR) was calculated following the methodology proposed by the University of Michigan Center for Costs and Renal Epidemiology (UM-KECC); a Cox proportional hazards survival model was implemented in two stages, the first estimated the parameters associated with the explanatory variables and the second standardized the results. Results: 9798 patients were evaluated, 4125 (42.1%) were women. The mean age was 59 years (SD = 15.6). There were 1253 death events (12.7%). The model gave a value of 1067 expected deaths, with an estimated SMR value of 1.17 (95% CI: 1.11-1.24). SMR was greater for diabetic patients 1.28 (95% CI: 1.19-1.38) and women (1.36 (95% CI: 1.25-1.48)) and it varied significantly depending on the region of the country (1.11 to 2.0). Conclusions: important differences in SMR according to sex, presence of diabetes and by regions of the country were found. Further studies are required to better understand the influence of these and other variables on the mortality phenomenon in dialysis in our context. (Acta Med Colomb 2017; 42: 106-111).

Early Peritonitis in a Large Peritoneal Dialysis Provider System in Colombia.

♦ BACKGROUND: Peritonitis is the most important complication of peritoneal dialysis (PD), and early peritonitis rate is predictive of the subsequent course on PD. Our aim was to calculate the early peritonitis rate and to identify characteristics and predisposing factors in a large nationwide PD provider network in Colombia. ♦ METHODS: This was a historical observational cohort study of all adult patients starting PD between January 1, 2012, and December 31, 2013, in 49 renal facilities in the Renal Therapy Services in Colombia. We studied the peritonitis rate in the first 90 days of treatment, its causative micro-organisms, its predictors and its variation with time on PD and between individual facilities. ♦ RESULTS: A total of 3,525 patients initiated PD, with 176 episodes of peritonitis during 752 patient-years of follow-up for a rate of 0.23 episodes per patient year equivalent to 1 every 52 months. In 41 of 49 units, the rate was better than 1 per 33 months, and in 45, it was better than 1 per 24 months. Peritonitis rates did not differ with age, ethnicity, socioeconomic status, or PD modality. We identified high incidence risk periods at 2 to 5 weeks after initiation of PD and again at 10 to 12 weeks. ♦ CONCLUSION: An excellent peritonitis rate was achieved across a large nationwide network. This occurred in the context of high nationwide PD utilization and despite high rates of socioeconomic deprivation. We propose that a key factor in achieving this was a standardized approach to management of patients.

Frecuencia y costos de hospitalización en una población de pacientes en diálisis en Colombia / Hospitalisation frequency and costs in a population of Colombian dialysis patients

Antecedentes. Los eventos de hospitalización son frecuentes en pacientes con enfermedad renal crónica terminal. Objetivo. Medir la frecuencia, duración de los eventos de hospitalización y el peso económico de ellas en estas población. Métodos. Estudio de cohorte dinámica retrospectiva, de pacientes prevalentes en terapia dialítica durante el año 2010. Se midió la frecuencia de hospitalización, tanto en hemodiálisis (HD) como en diálisis peritoneal (DP), El número de días de hospitalización, el monto total de la cuenta hospitalaria y el costo promedio del día de hospitalización. Se evaluaron los factores relacionados con el costo de hospitalización mediante análisis multivariable con un modelo lineal generalizado gama con enlace log. Resultados. La tasa de hospitalización fue 0,72 hospitalizaciones por pacienteaño, con 6,32 días hospitalarios por pacienteaño y media de 8,68 días por hospitalización. No hubo diferencias en estas tasas entre pacientes de hemodiálisis y de diálisis peritoneal. El monto total de la cuenta tuvo una mediana de $2.567.680. Conclusion. La población de estudio tuvo unas tasas de hospitalización y de días de estancia hospitalaria menores que en otros reportes. No se encontraron diferencias en estas tasas entre los pacientes de HD y DP.

Background and objectives. Chronic renal disease patients are often hospitalised. The present study was carried out as no studies have measured such population's hospitalisation frequency and duration in Colombia nor has their economic burden been analysed. Methods. This was a dynamic retrospective cohort study of patients receiving dialysis therapy during 2010. Haemodialysis (HD) and peritoneal dialysis (PD hospitalisation frequency was measured, as were the number of days spent in hospital, total hospital bill and average cost per day of hospitalisation. Multivariate analysis was used for evaluating factors related to hospitalisation cost (i.e. a generalised linear model with log link). Results. Hospitalisation rate was 0.72 hospitalisations per patient/ year, 6.32 days were spent in hospital per patient/year and average hospitalisation rate was 8.68 days. No differences were observed between haemodialysis patients and peritoneal dialysis regarding such rates. Average hospitalisation bill was $2,567,680. Conclusion. The study population had higher hospitalisation rates and spent less days in hospital than that stated in other reports. No differences were observed between HD and PD patients regarding these rates.