Randomized, controlled trial of glucose-sparing peritoneal dialysis in diabetic patients.

Glucose-containing peritoneal dialysis solutions may exacerbate metabolic abnormalities and increase cardiovascular risk in diabetic patients. Here, we examined whether a low-glucose regimen improves metabolic control in diabetic patients undergoing peritoneal dialysis. Eligible patients were randomly assigned in a 1:1 manner to the control group (dextrose solutions only) or to the low-glucose intervention group (IMPENDIA trial: combination of dextrose-based solution, icodextrin and amino acids; EDEN trial: a different dextrose-based solution, icodextrin and amino acids) and followed for 6 months. Combining both studies, 251 patients were allocated to control (n=127) or intervention (n=124) across 11 countries. The primary endpoint was change in glycated hemoglobin from baseline. Mean glycated hemoglobin at baseline was similar in both groups. In the intention-to-treat population, the mean glycated hemoglobin profile improved in the intervention group but remained unchanged in the control group (0.5% difference between groups; 95% confidence interval, 0.1% to 0.8%; P=0.006). Serum triglyceride, very-low-density lipoprotein, and apolipoprotein B levels also improved in the intervention group. Deaths and serious adverse events, including several related to extracellular fluid volume expansion, increased in the intervention group, however. These data suggest that a low-glucose dialysis regimen improves metabolic indices in diabetic patients receiving peritoneal dialysis but may be associated with an increased risk of extracellular fluid volume expansion. Thus, use of glucose-sparing regimens in peritoneal dialysis patients should be accompanied by close monitoring of fluid volume status.

Psychometric properties of the Kidney Disease Quality of Life short form 36 (KDQOL-36) scale for the assessment of quality of life in Colombian patients with chronic kidney disease on dialysis.

PURPOSE: Considering the importance of incorporating quality of life (QoL) construct during the health care of patients with stage 5 chronic kidney disease (CKD) on dialysis, it is necessary to have evidence on the clinimetric properties of the instruments used for its measurement. This study aimed to establish the clinimetric properties of the Kidney Disease Quality of Life Short Form 36 (KDQOL-36) scale in patients with stage 5 CKD on dialysis in Colombia. METHODS: A scale validation study was conducted using the classical test theory methodology. The statistical analysis included exploratory factor analysis (EFA) and confirmatory (CFA) techniques performed on two independent subsamples; concurrent criterion validity assessments; internal consistency using four different coefficients; test-retest reliability; and sensitivity to change using mixed model for repeated measures. RESULTS: The KDQOL-36 scale was applied to 506 patients with a diagnosis of stage 5 CKD on dialysis, attended in five renal units in Colombia. The EFA endorsed the three-factor structure of the scale, and the CFA showed an adequate fit of both the original and empirical models. Spearman's correlation coefficient values ≥0.50 were found between the domains of the CKD-specific core of the KDQOL-36 scale and the KDQ. Cronbach's alpha, McDonald's omega, Greatest lower bound (GLB), and Guttman's lambda coefficients were ≥0.89, indicating a high degree of consistency. A high level of concordance correlation was found between the two moments of application of the instrument, with values for Lin's concordance correlation coefficient ≥0.7. The application of the instrument after experiencing an event that could modify the quality of life showed statistically significant differences in the scores obtained. CONCLUSION: The KDQOL-36 scale is an adequate instrument for measuring QoL in Colombian patients with stage 5 CKD on dialysis.

Early outcomes of peritoneal dialysis in a middle-income country: A retrospective cohort study of a large dialysis network in Colombia.

BACKGROUND: The first year of dialysis is critical given the significant risk for complications following dialysis initiation. We analysed complications during the first year among incident peritoneal dialysis (PD) patients. METHODS: This retrospective cohort study comprised adult kidney failure patients starting PD in Baxter Renal Care Services in Colombia, receiving their first PD catheter between 1 January 2017 and 31 December 2020 and were followed up for up to 1 year. We analysed incidence, causes and factors associated with complications using logistic regression and transfer to haemodialysis (HD) using the Fine-Gray regression model. RESULTS: Among 4743 patients receiving their first PD catheter: 4628 (97.6%) of catheter implantations were successful; 377 (7.9%) patients experienced early complications. The incidence rate of complications during the year was 0.51 events per patient-year (95% CI: 0.48-0.54). Age, obesity and urgent start were associated with higher probability of complications after catheter implantation. The cumulative incidence of transfer to HD within 1 year of PD initiation was 10.1% [95% CI: 9.2-11.1%]. The hazard function for transfer to HD showed an accelerating pattern during the first month followed by progressive decrease during the first year. CONCLUSIONS: In this large population of incident PD patients, there is a high primary catheter placement success rate. Urgent start, age ≥65 years, obesity, centre size ≥150 PD patients and diabetes were risk factors associated with early complications. The follow-up of the cohort from day 1 of PD treatment showed that the risk for transfer to HD was higher during the first month.

Time on Therapy of Automated Peritoneal Dialysis with and without Remote Patient Monitoring: A Cohort Study.

Background: Remote patient monitoring (RPM) of patients undergoing automated peritoneal dialysis (APD-RPM) may potentially enhance time on therapy due to possible improvements in technique and patient survival. Objective: To evaluate the effect of APD-RPM as compared to APD without RPM on time on therapy. Methods: Adult incident APD patients undergo APD for 90 days or more in the Baxter Renal Care Services (BRCS) Colombia network between January 1, 2017, and June 30, 2019, with the study follow-up ending June 30, 2021. The exposure variable was APD-RPM vs. APD-without RPM. The outcomes of time on therapy and mortality rate over two years of follow-up were estimated in the full sample and in a matched population according to the exposure variable. A propensity score matching (PSM) 1:1 without replacement utilizing the nearest neighbor within caliper (0.035) was used and created a pseudopopulation in which the baseline covariates were well balanced. Fine & Gray multivariate analysis was performed to assess the effect of demographic, clinical, and laboratory variables on the risk of death, adjusting for the competing risks of technique failure and kidney transplantation. Results: In the matched sample, the time on APD therapy was significantly longer in the RPM group than in the non-RPM group, 18.95 vs. 15.75 months, p < 0.001. The mortality rate did not differ between the two groups: 0.10 events per patient-year in the RPM group and 0.12 in the non-RPM group, p=0.325. Conclusion: Over two years of follow-up, the use of RPM vs. no RPM in APD patients was associated with a significant increase in time on therapy, by 3.2 months. This result indicates that RPM-supported APD therapy may improve the clinical effectiveness and the overall quality of APD.

Variation in Peritoneal Dialysis Time on Therapy by Country: Results from the Peritoneal Dialysis Outcomes and Practice Patterns Study.

BACKGROUND AND OBJECTIVES: Quantifying contemporary peritoneal dialysis time on therapy is important for patients and providers. We describe time on peritoneal dialysis in the context of outcomes of hemodialysis transfer, death, and kidney transplantation on the basis of the multinational, observational Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS) from 2014 to 2017. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Among 218 randomly selected peritoneal dialysis facilities (7121 patients) in the PDOPPS from Australia/New Zealand, Canada, Japan, Thailand, the United Kingdom, and the United States, we calculated the cumulative incidence from peritoneal dialysis start to hemodialysis transfer, death, or kidney transplantation over 5 years and adjusted hazard ratios for patient and facility factors associated with death and hemodialysis transfer. RESULTS: Median time on peritoneal dialysis ranged from 1.7 (interquartile range, 0.8-2.9; the United Kingdom) to 3.2 (interquartile range, 1.5-6.0; Japan) years and was longer with lower kidney transplantation rates (range: 32% [the United Kingdom] to 2% [Japan and Thailand] over 3 years). Adjusted hemodialysis transfer risk was lowest in Thailand, but death risk was higher in Thailand and the United States compared with most countries. Infection was the leading cause of hemodialysis transfer, with higher hemodialysis transfer risks seen in patients having psychiatric disorder history or elevated body mass index. The proportion of patients with total weekly Kt/V ≥1.7 at a facility was not associated with death or hemodialysis transfer. CONCLUSIONS: Countries in the PDOPPS with higher rates of kidney transplantation tended to have shorter median times on peritoneal dialysis. Identification of infection as a leading cause of hemodialysis transfer and patient and facility factors associated with the risk of hemodialysis transfer can facilitate interventions to reduce these events. PODCAST: This article contains a podcast at https://www.asn-online.org/media/podcast/CJASN/2022_05_31_CJN16341221.mp3.

Medium Cutoff Versus High-Flux Hemodialysis Membranes and Clinical Outcomes: A Cohort Study Using Inverse Probability Treatment Weighting.

Rationale & Objective: This study investigated the effects on patients' outcomes of using medium cutoff (MCO) versus high-flux (HF) dialysis membranes. Study Design: A retrospective, observational, multicenter, cohort study. Setting & Participants: Patients aged greater than 18 years receiving hemodialysis at the Baxter Renal Care Services dialysis network in Colombia. The inception of the cohort occurred from September 1, 2017, to November 30, 2017, with follow-up to November 30, 2019. Exposure: The patients were divided into 2 cohorts according to the dialyzer used at the inception: (1) MCO membrane or (2) HF membrane. Outcomes: Primary outcomes were the hospitalization rate from any cause and hospitalization days per patient-year. Secondary outcomes were acute cardiovascular events and mortality rates from any cause and secondary to cardiovascular causes. Laboratory parameters were assessed throughout the 2-year follow-up period. Analytical Approach: Descriptive statistics were used to report population characteristics. Inverse probability of treatment weighting was applied to each group before analysis. All categorical variables were compared using Pearson's χ2 test, and continuous variables were analyzed with the t test. Baseline differences between groups with a value of >10% were considered clinically meaningful. Laboratory variables were measured at 5 consecutive time points. A between-patient effect was analyzed using a split-plot factorial analysis of variance. Results: The analysis included 1,098 patients, of whom 564 (51.3%) were dialyzed with MCO membranes and 534 (48.7%) with HF membranes. Patients receiving hemodialysis with MCO membranes had a lower all-cause hospitalization incidence rate (IR) per patient-year (IR = 0.93; 95% CI, 0.82-1.03) than those receiving hemodialysis with HF membranes (IR = 1.13; 95% CI, 0.96-1.30), corresponding to a significant incident rate ratio (MCO/HF) of 0.82 (95% CI, 0.68-0.99; P = 0.04). The frequency of nonfatal cardiovascular events showed statistical significance, with a lower incidence in the MCO group (incident rate ratio = 0.66; 95% CI, 0.46-0.96; P = 0.03). No statistically significant differences in all-cause time until death were observed (P = 0.48). Albumin levels were similar between the 2 dialyzer cohorts. Limitations: Despite the robust statistical analysis, there remains the possibility that unmeasured variables may still generate residual imbalance and, therefore, skew the results. Conclusions: The incidences of hospitalization and cardiovascular events in patients receiving hemodialysis were lower when dialyzed with MCO membranes than HF membranes. A randomized controlled trial would be desirable to confirm these results. Trial Registration: Clinical Trials.gov, ISRCTN12403265.

Hemodialysis vs Peritoneal Dialysis: Comparison of Net Survival in Incident Patients on Chronic Dialysis in Colombia.

BACKGROUND: In the area of nephrology, the practical application of relative survival methodologies can provide information regarding the impact of outcomes for patients with kidney failure on dialysis compared with what would be expected in the absence of this condition. OBJECTIVE: Compare the net survival of hemodialysis (HD) and peritoneal dialysis (PD) patients in a cohort of incident patients on chronic dialysis in Colombia, according to the dialysis therapy modality. DESIGN: Observational, analytic, historical cohort. SETTING: Renal Therapy Services (RTS) clinic network across Colombia. PATIENTS: Patients over 18 years old with chronic kidney disease, incidents in dialytic therapy, which reached day 90 of therapy. Recruitment took place from January 1, 2008, to December 31, 2013, with a follow-up until December 31, 2018. The final cohort for analysis corresponds to a total of 12 508 patients, of which 5330 patients (42.6%) began HD and 7178 patients (57.4%) began PD. MEASUREMENTS: Demographic, socioeconomic, and clinical variables were measured. METHODS: Analyses were conducted according to the treatment assigned (PD or HD) at the time of the inception of the cohort and another approach of analysis was done with a subsample of those patients who never changed the initial modality. To calculate expected survival, life tables were constructed for Colombia for the years 2006 to 2018. Net survival estimates were made using the Pohar Perme estimator. The comparison of the net survival curves was done using the method developed by Pavlic and Perme, the log-rank type. RESULTS: Net survival at 5 years compared with the general population was estimated at 0.53 (95% confidence interval 0.52-0.54) in the dialysis cohort. In intention-to-treat analyses of 7178 patients on PD and 5330 patients on HD, by global and Pohar-Perme methods, survival (expressed as a ratio of survival in patients on dialysis to survival in an age-, sex- and geographic-matched general Colombian population) was higher in patients on HD than in those on PD. In year 1, net survival by Pavlov-Perme on PD was 0.79 (95% confidence intervals [CI] 0.78 - 0.80) and on HD 0.85 (95% CI 0.84 - 0.86); in year 5, 0.36 (95% CI 0.34 - 0.38) and 0.57 (95% CI 0.55 - 0.59) for PD and HD respectively. LIMITATION: There may be imbalances among the populations analyzed (HD vs PD), in which one or more variables other than the type of therapy may influence the survival of the patients. In Colombia there are marginal levels of underreporting of demographic data in some subpopulations that may affect life-tables construction. CONCLUSION: An important difference was observed in terms of survival between the dialysis population and the population of reference without dialysis. Statistically significant differences were found in net survival between HD and PD, net survival was higher in patients on HD than in those on PD.

CONTEXTE: En néphrologie, l'application pratique des méthodologies de survie relative peut fournir des renseignements sur l'impact des résultats des patients atteints d'insuffisance rénale suivant des traitements de dialyse comparativement à ce qui serait attendu en l'absence de cette affection. OBJECTIF: Comparer la survie nette, selon la modalité de dialyse, dans une cohorte de patients colombiens traités par hémodialyse (HD) ou par dialyse péritonéale (DP) de façon chronique. TYPE D'ÉTUDE: Étude de cohorte observationnelle, analytique et historique. CADRE: Le réseau Renal Therapy Services (RTS) de la Colombie. SUJETS: Des patients adultes souffrant d'insuffisance chronique ayant nouvellement débuté la dialyse depuis plus de 90 jours. Le recrutement a eu lieu du 1er janvier 2008 au 31 décembre 2013, et le suivi s'est poursuivi jusqu'au 31 décembre 2018. L'analyse porte sur un total de 12 508 patients, dont 5 330 (42,6 %) avaient entrepris des traitements d'hémodialyse et 7 178 (57,4 %) de dialyse péritonéale. MESURES: Les données démographiques, socio-économiques et cliniques des patients. MÉTHODOLOGIE: Les analyses ont été menées en fonction du traitement attribué (DP ou HD) au moment de la création de la cohorte. Une autre analyse a été réalisée sur un sous-échantillon de patients n'ayant jamais changé la modalité depuis le début du traitement. Des tables de survie spécifiques à la Colombie entre les années 2006 et 2018 ont été élaborées pour calculer la survie attendue. Les estimations de survie nette ont été faites en utilisant l'estimateur de Pohar Perme. Et la méthode développée par Pavlic et Perme, soit le test du log-rank a servi à la comparaison des courbes de survie nette. RÉSULTATS: La survie nette après cinq ans, comparée à celle de la population générale, a été estimée à 0,53 (IC 95 %: 0,52 à 0,54) dans la cohorte de patients dialysés. Dans les analyses en intention de traiter portant sur 7 178 patients sous HD et 5 330 patients sous DP ­ réalisées par méthode globale et avec l'estimateur Pohar Perme ­ la survie (exprimée sous forme de rapport entre la survie de patients dialysés et la survie de Colombiens de la population générale du même âge, sexe et région géographique) s'est avérée plus élevée chez les patients sous HD que chez les patients sous DP. Au cours de la première année, la survie nette (Pavlov Perme) des patients sous DP s'établissait à 0,79 (IC 95 % : 0,78-0,80) et celle des patients sous HD à 0,85 (IC 95 % : 0,84-0,86); après cinq ans, elle était passée à 0,36 (IC 95 % : 0,34-0,38) pour les patients sous DP et à 0,57 (IC 95 % : 0,55-0,59) pour les patients sous HD. LIMITES: Il pourrait exister des disparités parmi les populations analysées (HD vs DP), où des variables autres que la modalité pourraient influencer la survie des patients. Il existe, dans certaines sous-populations de Colombie, des niveaux marginaux de sous-déclaration des données démographiques qui pourraient affecter l'élaboration des tables de survie. CONCLUSION: Une différence importante a été observée entre la survie des patients dialysés et celle d'une population de référence (personnes non dialysées). On a également constaté des différences statistiquement significatives entre le groupe sous HD et le groupe sous DP en ce qui concerne la survie nette, laquelle s'est avérée plus élevée chez les patients sous HD.

An initial evaluation of expanded hemodialysis on hospitalizations, drug utilization, costs, and patient utility in Colombia.

To examine new evidence linking expanded hemodialysis (HDx) using a medium cut-off (MCO) membrane with hospitalizations, hospital days, medication use, costs, and patient utility. This retrospective study utilized data from Renal Care Services medical records database in Colombia from 2017 to 2019. Clinics included had switched all patients from high flux hemodialysis (HD HF) to HDx and had at least a year of data on HD HF and HDx. Data included demographic characteristics, comorbidities, years on dialysis, hospitalizations, medication use, and quality of life measured by the 36 item and Short Form versions of the Kidney Disease Quality of Life survey at the start of HDx, and 1 year after HDx, which were mapped to EQ-5D utilities. Generalized linear models were run on the outcomes of interest with an indicator for being on HDx. Annual cost estimates were also constructed. The study included 81 patients. HDx was significantly associated with lower dosing of erythropoietin stimulating agents, iron, hypertension medications, and insulin. HDx was also significantly associated with lower hospital days per year (5.94 on HD vs. 4.41 on HDx) although not with the number of hospitalizations. Estimates of annual hospitalization costs were 23.9% lower using HDx and patient utilities did not appear to decline. HDx was statistically significantly associated with reduced hospitalization days and lower medication dosages. Furthermore, this preliminary analysis suggested potential for HDx being a dominant strategy in terms of costs and utility and should motivate future work with larger samples and better controls.

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.

Policies and health care financing issues for dialysis in Latin America: extracts from the roundtable discussion on the economics of dialysis and chronic kidney disease.

During the 2008 Congress of the International Society for Peritoneal Dialysis, academic nephrologists, nephrology societies, and government officials from Colombia, Brazil, Argentina, Chile, Central America, Ecuador, and Mexico participated in a roundtable discussion on the Economics of Dialysis and Chronic Kidney Disease in Latin America. The main focus was policy and health care financing. The roundtable promoted open discussion between policymakers and clinicians on how to find viable solutions to contain spending on treatment for end-stage renal disease into the future. A number of options were proposed, including early medical intervention (disease management programs) to slow the progression of chronic kidney disease in high-risk patients, promotion of pre-emptive renal transplantation, and use of the most cost-effective dialysis therapy that can be offered to a patient without compromising outcome. It was concluded that the burden of treating more patients in the future could be alleviated by wider utilization of peritoneal dialysis (PD). However, important changes in health care reimbursement systems and realignment of incentives in the region are required to support wider PD penetration.

Prevalence of periodontitis in a population of patients on dialysis in Colombia.

The aim of this study is to establish the prevalence of Chronic Periodontitis (CP) in patients with Chronic Kidney Disease (CKD) and to ascertain its relationship with several factors or indicators of micro inflammation. One hundred and thirty-jive CKD patients on dialysis treatment were included. Biochemical parameters, clinical attachment level and pocket depth were recorded according of the American Academy of Periodontology and the CDC (CDC-AAP). Gingivitis and CP were recorded based on the biofilm-gingival interface (BGI) periodontal diseases classification. The rate of non-response to the survey was 10 percent. A total 2,636 teeth in 135 patients were examined, of whom 52.5% were males. Average age was 55.7 years (SD ± 1.32); 41.4% had a smoking history; 78/135 patients were on hemodialysis and 57/135 on peritoneal dialysis; 55.5% had been on dialysis for more than three years. Prevalence of gingivitis and periodontitis was 14.8%, 95% CI (9.7-21.9) and 82.2%, 95% CI (74.7 - 87.8), respectively; according to the BGI Index. Severity of CP was: No periodontitis, 14.0% 95% CI (9.1 - 21.1); mild, 11.1% 95% CI (6.7 -17.7); moderate, 28.8% 95% CI (21.7- 37.1); and severe, 45.9% 95% CI (31.6-54.47). Peritoneal dialysis and time on dialysis > 3 years increase the chance of having periodontitis, OR 11.0 95% CI (2.2-53.8) and OR 7.6 95% CI (1.1-50.2), respectively. In view of the high prevalence of CP in this population, programs designed to ensure better periodontal and gingival care in the population on dialysis need to be established.

El objetivo de este estudio fue establecer la prevalencia de Periodontitis Crónica (PC) en pacientes con enfermedad renal crónica (ERC) en diálisis y determinar la relación de su presencia con algunos indicadores de micro inflamación. Un total de 135 pacientes con ERC en terapia dialítica fueron incluidos en este estudio. Se evaluaron parámetros bioquímicos, nivel de inserción clínica (NIC) y profundidad de sondaje (PS), de acuerdo con la Asociación Americana de Periodoncia y el CDC de Atlanta (CDC-AAP). También fue evaluada, la gingivitis y la PC de acuerdo con la clasificación interface biopelicula-encia (BGI). La tasa de no respuesta a la encuesta fue del 10%. Un total de 2636 dientes en 135 pacientes fueron evaluados, (52.5% hombres, edad promedio 55.7 ± 1.32), 56% con antecedente de tabaquismo. 78/135 en hemodiálisis y 57/135 en diálisis peritoneal, el 55.5 % con un tiempo en diálisis mayor a tres años. La prevalencia de gingivitis por la clasificación BGI fue del 14.8% IC 95% (9.7 - 21.9) y de periodontitis 82.2% IC 95% (74.7 - 87.8). La severidad de la PC fue: sin periodontitis 14.0% 95% IC (9.1 - 21.1); leve 11.1% 95% IC (6.7 - 17.7); moderada 28.8% 95% IC (21.7 - 37.1) y severa 45.9% 95% IC (31.6-54.47) La diálisis peritoneal y el tiempo en diálisis aumentaron la chance de tener PC: OR 11.0 95% IC (2.2-53.8) y OR 7.6 95% CI (1.1-50.2) respectivamente. Por la alta prevalencia de PC en esta población, es necesario establecer programas para asegurar el cuidado de la salud periodontal en esta población en diálisis.

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.

Traducción y adaptación transcultural del instrumento Kidney Disease Questionnaire (KDQ) para la evaluación de calidad de vida en pacientes con enfermedad renal crónica en Colombia

Contexto: dada la importancia de incorporar la calidad de vida durante la atención de los pacientes con enfermedad renal crónica (ERC), es necesario disponer de versiones traducidas y adaptadas transculturalmente de diferentes instrumentos diseñados para la medición de este constructo. Objetivo: traducir y adaptar transculturalmente al español hablado en Colombia el instrumento Kidney Disease Questionnaire (KDQ), para medir la calidad de vida en pacientes con ERC en insuficiencia renal. Metodología: el proceso se llevó a cabo siguiendo la metodología propuesta por la Eortc, que incluye traducciones directas, traducciones inversas y una prueba piloto llevada a cabo en un grupo de pacientes con diagnóstico de ERC en diálisis, atendidos en unidades renales de Baxter Renal Care Services®, en Bogotá, Colombia. Resultados: en el proceso se identificaron (I) casos que requirieron de consenso para seleccionar la traducción que mejor conservaba el significado y la equivalencia semántica del instrumento, (II) diferencias en la sintaxis o uso de paráfrasis, (III) se consideró pertinente realizar algunos cambios mínimos en el uso o la disposición de preposiciones o artículos, con el fin de que los ítems y las opciones de respuesta se leyeran de una manera más natural. Los cambios más notorios fueron en los ítems 18, 19 y 21, en los que para una mejor compresión de la pregunta, se identificó la necesidad de agregar determinadas expresiones o palabras. Conclusiones: se tiene disponible la versión traducida al español y adaptada culturalmente a la población colombiana del KDQ. El siguiente paso a fin de utilizar el instrumento en el país, es disponer de evidencia sobre sus propiedades clinimétricas.

Background: Considering the importance of incorporating quality of life during the care of patients with chronic kidney disease (CKD), it is necessary to have translated and cross-culturally adapted versions of different instruments designed to measure this construct. Purpose: To translate and cross-culturally adapt the Kidney Disease Questionnaire (KDQ) instrument for measuring quality of life in patients with CKD in renal failure to the Spanish spoken in Colombia. Methodology: The process was carried out following the methodology proposed by the EORTC, which includes direct translations, reverse translations and pilot test carried out in a group of patients with a diagnosis of CKD on dialysis, attended in renal units of Baxter Renal Care Services ®, in Bogota, Colombia. Results: In the process, cases were identified that required consensus to select the translation that best preserved the meaning and semantic equivalence of the instrument; differences in syntax or use of paraphrases; it was considered pertinent to make some minimal changes in the use or arrangement of prepositions or articles, so that the items and answer options would read in a more natural way; the most notorious changes were in items 18, 19 and 21, in which for a better understanding of the question, the need to add certain expressions or words was identified. Conclusions: The Spanish translated version and culturally adapted to the Colombian population of the KDQ is now available. The next step in order to use the instrument in the country is to have evidence on its clinimetric properties.

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.

Overview of peritoneal dialysis in Latin America.

Latin America is a heterogeneous region comprised of 20 countries, former colonies of European countries, in which Latin-derived languages are spoken. According to the Latin American Society of Nephrology and Hypertension/Sociedad Latino Americana de Nefrologia e Hipertensión (SLANH), the acceptance rate for renal replacement therapy is 103 new patients per million population. In Latin America, hemodialysis is the predominant form of replacement therapy for end-stage renal disease; however, some countries employ peritoneal dialysis (PD) in 30% or more patients. In particular, Mexico is the country with the largest PD utilization in the world, and furthermore, it is estimated that approximately 25% of the world's PD population may be found Latin America. Data concerning clinical practice and long-term outcome of PD in Latin America are scarce, although regional registries are increasing in number and quality. In this review article, we present an overview of the situation of PD in several countries of Latin America, based on the registry of the SLANH, national registries, and personal communication with PD experts from different countries.

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.

[Program for the prevention of chronic kidney disease based on integrated service networks in Colombia]. / Programa de prevención de la enfermedad renal crónica basado en redes integradas de servicios en Colombia.

OBJECTIVE: Chronic Kidney Disease (CKD) prevention programs allow to control morbidity and/or delay renal replacement therapy. The design of a CKD prevention program is described, including highlights on how the primary and secondary levels of care interact with each other through the characterization of the population admitted for secondary prevention. METHODS: The description of the program was based on a literature review. Descriptive statistics were used to characterize the patients participating in the program. RESULTS: The design and implementation of the prevention program was based on the integration of service networks and care levels. The main activities for the program were detailed according to the care level in which they performed. 3 487 patients in total were admitted for control at the second care level due to an estimated glomerular filtration rate of <60 mil/min; 87.81% of the patients were admitted with CKD stage 3 and a median glomerular filtration rate of 46.21mil/min. The main causes of CKD were hypertension and diabetes. On admission, 2 129 patients (61.05 %) had systolic blood pressure <140 mmHg and 3 091 (88.64 %) had diastolic blood pressure <90 mmHg; 357 (57.58 %), out of 620, diabetic patients with glycosylated hemoglobin presented values <7.5 %. CONCLUSION: A prevention program was designed and implemented to allow the integration of care levels oriented to a multidisciplinary intervention, which ultimately managed to recognize patients and to give continuity to care provision for a better control of CKD.

OBJETIVO: Los programas de prevención de la Enfermedad Renal Crónica (ERC) permiten controlar la morbimortalidad y/o retrasar el ingreso a terapia de reemplazo renal. Se documenta el diseño de un programa de prevención de la ERC y se describe cómo se integran los niveles primario y secundario de atención mediante la caracterización de una población admitida para prevención secundaria. MÉTODOS: La descripción del programa se realizó con base en una revisión documental. Para la caracterización de los pacientes participantes en el programa se utilizaron herramientas de estadística descriptiva. RESULTADOS: El diseño e implementación del programa de prevención se basó en la integración de redes de servicios y niveles de atención. Se detallan las actividades fundamentales del programa según el nivel de atención en el que se realizan. Un total de 3 487 pacientes fueron admitidos para control en el segundo nivel de atención por presentar tasa de filtración glomerular estimada <60 mil/min; 87,81 % de los pacientes ingresó en estadio 3 de la ERC con mediana de Tasa de Filtración Glomerular de 46,21mil/min; las principales causas de ERC fueron la hipertensión arterial y la diabetes. Al ingreso, 2 129 pacientes (61.05 %) tuvieron tensión arterial sistólica <140 mmHg y 3 091(88,64 %) diastólica <90mmHg; de 620 diabéticos con hemoglobina glicosilada, 357 (57,58 %) tuvieron valores <7,5 %. CONCLUSIÓN: Se diseñó e implementó un programa de prevención que permitió la integración de los niveles de atención para una intervención multidisciplinaria que logró la captación oportuna de pacientes y la continuidad en la atención para el mejor control de la ERC.

Remote Patient Management for Home Dialysis Patients.

Remote patient management (RPM) offers renal health care providers and patients with end-stage kidney disease opportunities to embrace home dialysis therapies with greater confidence and the potential to obtain better clinical outcomes. Barriers and evidence required to increase adoption of RPM by the nephrology community need to be clearly defined. Ten health care providers from specialties including nephrology, cardiology, pediatrics, epidemiology, nursing, and health informatics with experience in home dialysis and the use of RPM systems gathered in Vienna, Austria to discuss opportunities for, barriers to, and system requirements of RPM as it applies to the home dialysis patient. Although improved outcomes and cost-effectiveness of RPM have been demonstrated in patients with diabetes mellitus and heart disease, only observational data on RPM have been gathered in patients on dialysis. The current review focused on RPM systems currently in use, on how RPM should be integrated into future care, and on the evidence needed for optimized implementation to improve clinical and economic outcomes. Randomized controlled trials and/or large observational studies could inform the most effective and economical use of RPM in home dialysis. These studies are needed to establish the value of existing and/or future RPM models among patients, policy makers, and health care providers.

Outcomes of a peritoneal dialysis program in remote communities within Colombia.

BACKGROUND AND OBJECTIVE: Colombia is a country of diverse geographic regions, some with mountainous terrain that can make access to urban areas difficult for individuals who live in remote areas. In 2005, a program was initiated to establish remote peritoneal dialysis (PD) centers in Colombia to improve access to PD for patients with end-stage renal disease who face geographic or financial access barriers. PATIENTS AND METHODS: The present study was a multi-center cohort observational study of prevalent home PD patients who were at least 18 years of age and were being managed by one of nine established remote PD centers in Colombia over a 2-year period. Data were collected from clinical records, databases, and patient interviews. Patient survival, incidence of peritonitis, and rate of withdrawal from PD therapy were assessed. RESULTS: A total of 345 patients were eligible for the study. The majority (87.8%) of patients lived on one to two times a minimum monthly salary (equivalent to US$243 - US$486). On average, patients traveled 1.2 hours and 4.3 hours from their home to their remote PD center or an urban reference renal clinic, respectively. The incidence rate of peritonitis was 2.54 episodes per 100 patient-months of therapy. A bivariate analysis showed a significantly higher risk of peritonitis in patients who were living on less than one times a monthly minimum salary (p < 0.05) or who had a dirt, cement, or unfinished wood floor (p < 0.05). The 1-year and 2-year patient survival rates were 92.44% and 81.55%, respectively. The 1-year and 2-year technique survival rates were 97.27% and 89.78%, respectively. CONCLUSIONS: With the support of remote PD centers that mitigate geographic and financial barriers to healthcare, home PD therapy is a safe and appropriate treatment option for patients who live in remote areas in Colombia.

Prevalence of periodontitis in a population of patients on dialysis in Colombia

The aim of this study is to establish the prevalence of Chronic Periodontitis (CP) in patients with Chronic Kidney Disease (CKD) and to ascertain its relationship with several factors or indicators of micro inflammation. One hundred and thirtyfive CKD patients on dialysis treatment were included. Biochemical parameters, clinical attachment level and pocket depth were recorded according of the American Academy of Periodontology and the CDC (CDCAAP). Gingivitis and CP were recorded based on the biofilmgingival interface (BGI) periodontal diseases classification. The rate of nonresponse to the survey was 10 percent. A total 2,636 teeth in 135 patients were examined, of whom 52.5% were males. Average age was 55.7 years (SD ± 1.32); 41.4% had a smoking history; 78/135 patients were on hemodialysis and 57/135 on peritoneal dialysis; 55.5% had been on dialysis for more than three years. Prevalence of gingivitis and periodontitis was 14.8%, 95% CI (9.721.9) and 82.2%, 95% CI (74.7 ­ 87.8), respectively; according to the BGI Index. Severity of CP was: No periodontitis, 14.0% 95% CI (9.1 21.1) ; mild, 11.1% 95% CI (6.7 17.7) ; moderate, 28.8% 95% CI (21.7 37.1) ; and severe, 45.9% 95% CI (31.654.47). Peritoneal dialysis and time on dialysis > 3 years increase the chance of having periodontitis, OR 11.0 95% CI (2.253.8) and OR 7.6 95% CI (1.150.2), respectively. In view of the high prevalence of CP in this population, programs designed to ensure better periodontal and gingival care in the population on dialysis need to be established (AU)

El objetivo de este estudio fue establecer la prevalencia de Periodontitis Crónica (PC) en pacientes con enfermedad renal crónica (ERC) en diálisis y determinar la relación de su presencia con algunos indicadores de micro inflamación. Un total de 135 pacientes con ERC en terapia dialítica fueron incluidos en este estudio. Se evaluaron parámetros bioquímicos, nivel de inserción clínica (NIC) y profundidad de sondaje (PS), de acuerdo con la Asociación Americana de Periodoncia y el CDC de Atlanta (CDCAAP). También fue evaluada, la gingivitis y la PC de acuerdo con la clasificación interface biopeliculaencia (BGI). La tasa de no respuesta a la encuesta fue del 10%. Un total de 2636 dientes en 135 pacientes fueron evaluados, (52.5% hombres, edad promedio 55.7 ± 1.32), 56% con antecedente de tabaquismo. 78/135 en hemodiálisis y 57/135 en diálisis peritoneal, el 55.5 % con un tiempo en diálisis mayor a tres años. La prevalencia de gingivitis por la clasificación BGI fue del 14.8% IC 95% (9.7 21.9) y de periodontitis 82.2% IC 95% (74.7 ­ 87.8). La severidad de la PC fue: sin periodontitis 14.0% 95% IC (9.1 21.1) ; leve 11.1% 95% IC (6.7 17.7) ; moderada 28.8% 95% IC (21.7 37.1) y severa 45.9% 95% IC (31.654.47) La diálisis peritoneal y el tiempo en diálisis aumentaron la chance de tener PC: OR 11.0 95% IC (2.253.8) y OR 7.6 95% CI (1.150.2) respectiva mente. Por la alta prevalencia de PC en esta población, es necesario establecer programas para asegurar el cuidado de la salud periodontal en esta población en diálisis (AU)