RESUMEN
BACKGROUND: High interdialytic weight gain (IDWG) is associated with adverse outcomes in hemodialysis (HD) patients. We identified temporal and regional trends in IDWG, predictors of IDWG, and associations of IDWG with clinical outcomes. STUDY DESIGN: Analysis 1: sequential cross-sections to identify facility- and patient-level predictors of IDWG and their temporal trends. Analysis 2: prospective cohort study to assess associations between IDWG and mortality and hospitalization risk. SETTING & PARTICIPANTS: 21,919 participants on HD therapy for 1 year or longer in the Dialysis Outcomes and Practice Patterns Study (DOPPS) phases 2 to 5 (2002-2014). PREDICTORS: Analysis 1: study phase, patient demographics and comorbid conditions, HD facility practices. Analysis 2: relative IDWG, expressed as percentage of post-HD weight (<0%, 0%-0.99%, 1%-2.49%, 2.5%-3.99% [reference], 4%-5.69%, and ≥5.7%). OUTCOMES: Analysis 1: relative IDWG as a continuous variable using linear mixed models; analysis 2: mortality; all-cause and cause-specific hospitalization using Cox regression, adjusting for potential confounders. RESULTS: From phase 2 to 5, IDWG declined in the United States (-0.29kg; -0.5% of post-HD weight), Canada (-0.25kg; -0.8%), and Europe (-0.22kg; -0.5%), with more modest declines in Japan and Australia/New Zealand. Among modifiable factors associated with IDWG, the most notable was facility mean dialysate sodium concentration: every 1-mEq/L greater dialysate sodium concentration was associated with 0.13 (95% CI, 0.11-0.16) greater relative IDWG. Compared to relative IDWG of 2.5% to 3.99%, there was elevated risk for mortality with relative IDWG≥5.7% (adjusted HR, 1.23; 95% CI, 1.08-1.40) and elevated risk for fluid-overload hospitalization with relative IDWG≥4% (HRs of 1.28 [95% CI, 1.09-1.49] and 1.64 [95% CI, 1.27-2.13] for relative IDWGs of 4%-5.69% and ≥5.7%, respectively). LIMITATIONS: Possible residual confounding. No dietary salt intake data. CONCLUSIONS: Reductions in IDWG during the past decade were partially explained by reductions in dialysate sodium concentration. Focusing quality improvement strategies on reducing occurrences of high IDWG may improve outcomes in HD patients.
Asunto(s)
Fallo Renal Crónico/terapia , Diálisis Renal , Aumento de Peso , Femenino , Hospitalización/estadística & datos numéricos , Humanos , Fallo Renal Crónico/mortalidad , Masculino , Persona de Mediana Edad , Evaluación de Resultado en la Atención de Salud , Pautas de la Práctica en Medicina , Estudios Prospectivos , Factores de TiempoRESUMEN
Dialysis procedure rates in Germany were changed in 2002 from per-session to weekly flat rate payments, and quality assurance was introduced in 2009 with defined treatment targets for spKt/V, dialysis frequency, treatment time, and hemoglobin. In order to understand trends in treatment parameters before and after the introduction of these changes, we analyzed data from 407 to 618 prevalent patients each year (hemodialysis over 90 days) in 14-21 centers in cross-sections of the Dialysis Outcomes and Practice Patterns Study (phases 1-4, 1998-2011). Descriptive statistics were used to report differences over time in the four quality assurance parameters along with erythropoietin-stimulating agent (ESA) and intravenous iron doses. Time trends were analyzed using linear mixed models adjusted for patient demographics and comorbidities. The proportion of patients with short treatment times (less than 4 h) and low spKt/V (below 1.2) improved throughout the study and was lowest after implementation of quality assurance. Hemoglobin levels have increased since 1998 and remained consistent since 2005, with only 8-10% of patients below 10 g/dl. About 90% of patients were prescribed ESAs, with the dose declining since peaking in 2006. Intravenous iron use was highest in 2011. Hence, trends to improve quality metrics for hemodialysis have been established in Germany even after introduction of flat rate reimbursement. Thus, analysis of facility practice patterns is needed to maintain quality of care in a cost-containment environment.
Asunto(s)
Fallo Renal Crónico/epidemiología , Fallo Renal Crónico/terapia , Pautas de la Práctica en Medicina/tendencias , Garantía de la Calidad de Atención de Salud/tendencias , Mecanismo de Reembolso/tendencias , Diálisis Renal/economía , Anciano , Anciano de 80 o más Años , Estudios de Cohortes , Control de Costos , Relación Dosis-Respuesta a Droga , Eritropoyetina/uso terapéutico , Femenino , Alemania/epidemiología , Hemoglobinas/metabolismo , Humanos , Hierro/uso terapéutico , Fallo Renal Crónico/sangre , Modelos Lineales , Masculino , Persona de Mediana Edad , Pautas de la Práctica en Medicina/economía , Estudios Prospectivos , Garantía de la Calidad de Atención de Salud/economía , Mecanismo de Reembolso/economía , Estudios Retrospectivos , Factores de TiempoRESUMEN
BACKGROUND: Longer dialysis session length (treatment time, TT) has been associated with better survival among hemodialysis (HD) patients. The impact of TT on clinical markers that may contribute to this survival advantage is not well known. METHODS: Using data from the international Dialysis Outcomes and Practice Patterns Study, we assessed the association of TT with clinical outcomes using both standard regression analyses and instrumental variable approaches. The study included 37,414 patients on in-center HD three times per week with prescribed TT from 120 to 420 min. RESULTS: Facility mean TT ranged from 214 min in the USA to 256 min in Australia-New Zealand. Accounting for country effects, mortality risk was lower for patients with longer TT {hazard ratio for every 30 min: all-cause mortality: 0.94 [95% confidence interval (CI): 0.92-0.97], cardiovascular mortality: 0.95 (95% CI: 0.91-0.98) and sudden death: 0.93 (95% CI: 0.88-0.98)}. Patients with longer TT had lower pre- and post-dialysis systolic blood pressure, greater intradialytic weight loss, higher hemoglobin (for the same erythropoietin dose), serum albumin and potassium and lower serum phosphorus and white blood cell counts. Similar associations were found using the instrumental variable approach, although the positive associations of TT with weight loss and potassium were lost. CONCLUSIONS: Favorable levels of a variety of clinical markers may contribute to the better survival of patients receiving longer TT. These findings support longer TT prescription in the setting of in-center, three times per week HD.
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Mortalidad , Diálisis Renal/estadística & datos numéricos , Diálisis Renal/normas , Anciano , Australia/epidemiología , Estudios de Cohortes , Femenino , Estudios de Seguimiento , Hospitalización , Humanos , Masculino , Persona de Mediana Edad , Nueva Zelanda/epidemiología , Estudios Prospectivos , Análisis de Supervivencia , Factores de Tiempo , Resultado del Tratamiento , Estados Unidos/epidemiologíaRESUMEN
BACKGROUND: Levels of physical exercise among haemodialysis patients are low. Increased physical activity in this population has been associated with improved health-related quality of life (HRQoL) and survival. However, results of previous studies may not be applicable to the haemodialysis population as a whole. The present study provides the first description of international patterns of exercise frequency and its association with exercise programmes and clinical outcomes among participants in the Dialysis Outcomes and Practice Patterns Study (DOPPS). METHODS: Data from a cross section of 20,920 DOPPS participants in 12 countries between 1996 and 2004 were analysed. Regular exercise was defined as exercise frequency equal to or more than once/week based on patient self-report. Linear mixed models and logistic regression assessed associations of exercise frequency with HRQoL and other psychosocial variables. Mortality risk was calculated in Cox proportional hazard models using patient-level (patient self-reported exercise frequency) and facility-level (the dialysis facility percentage of regular exercisers) predictors. RESULTS: Regular exercise frequency varied widely across countries and across dialysis facilities within a country. Overall, 47.4% of participants were categorized as regular exercisers. The odds of regular exercise was 38% higher for patients from facilities offering exercise programmes (adjusted odds ratio = 1.38 [95% confidence interval: 1.03-1.84]; P = 0.03). Regular exercisers had higher HRQoL, physical functioning and sleep quality scores; reported fewer limitations in physical activities; and were less bothered by bodily pain or lack of appetite (P Asunto(s)
Terapia por Ejercicio
, Fallo Renal Crónico/terapia
, Evaluación de Resultado en la Atención de Salud
, Pautas de la Práctica en Medicina
, Calidad de Vida
, Diálisis Renal/mortalidad
, Anciano
, Estudios Transversales
, Femenino
, Estudios de Seguimiento
, Humanos
, Agencias Internacionales
, Masculino
, Persona de Mediana Edad
, Diálisis Renal/psicología
, Resultado del Tratamiento
RESUMEN
We evaluated risks associated with elevated alkaline phosphatase in hemodialysis patients using longitudinal data from the Dialysis Outcomes and Practice Patterns Study, a prospective observational study of hemodialysis patients in 12 countries. Alkaline phosphatase levels were normalized by the upper limit of the laboratory-reported reference range. Cause-specific hospitalization and mortality risks were evaluated using Cox proportional hazards models, stratified by region and adjusted for phosphorus, calcium, albumin, parathyroid hormone, case mix, and numerous comorbidities. The odds of high normalized alkaline phosphatase were increased twofold in the United States in comparison to Japan. Elevations of normalized alkaline phosphatase were significantly associated with several comorbid conditions, increased fractures, parathyroidectomy, risk of hospitalization due to major adverse cardiac events, higher all-cause cardiovascular, and infection-related mortality risk. Our results also show that elevated serum normalized alkaline phosphatase was associated with higher risks of hospitalization and death in hemodialysis patients, independent of calcium, phosphorus, and parathyroid hormone levels.
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Fosfatasa Alcalina/sangre , Diálisis Renal/efectos adversos , Diálisis Renal/mortalidad , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Calcio/sangre , Enfermedades Cardiovasculares/sangre , Enfermedades Cardiovasculares/mortalidad , Femenino , Hospitalización , Humanos , Infecciones/sangre , Infecciones/mortalidad , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Hormona Paratiroidea/sangre , Fósforo/sangre , Modelos de Riesgos Proporcionales , Estudios Prospectivos , Factores de RiesgoRESUMEN
BACKGROUND: The different efficacy of subcutaneous and intravenous rHuEPO results in higher doses and costs in intravenously treated patients. Darbepoetin alfa has a different pharmacokinetic profile compared to rHuEPO, and previous clinical experience suggests that subcutaneous and intravenous darbepoetin alfa may have similar efficacy. Objective. The aim of this study was to compare the efficacy of intravenous and subcutaneous darbepoetin alfa regarding haemoglobin levels and doses. METHODS: Patients treated with subcutaneous darbepoetin alfa for at least 6 months were randomized 1:1 to continue with subcutaneous treatment of darbepoetin alfa or to switch to the intravenous administration route. The application frequency was not altered. Darbepoetin alfa dose as well as haemoglobin concentrations were evaluated as per patient average at baseline (Week -3 +/- 1), Week 24 +/- 3 and Week 48 +/- 3. RESULTS: One hundred fourteen patients in 9 German dialysis centres were included. Fifty-three patients were treated intravenously and 61 patients continued the subcutaneous therapy. Mean haemoglobin levels and mean weekly darbepoetin alfa dose did not change significantly in either treatment group. CONCLUSIONS: Our data suggest that the darbepoetin alfa dose can be kept constant if patients are switched from subcutaneous to intravenous treatment.
Asunto(s)
Eritropoyetina/análogos & derivados , Hemoglobinas/metabolismo , Diálisis Renal , Anciano , Anemia/sangre , Anemia/tratamiento farmacológico , Anemia/etiología , Darbepoetina alfa , Relación Dosis-Respuesta a Droga , Tolerancia a Medicamentos , Eritropoyetina/administración & dosificación , Eritropoyetina/efectos adversos , Femenino , Alemania , Hematínicos/administración & dosificación , Hematínicos/efectos adversos , Humanos , Inyecciones Intravenosas , Inyecciones Subcutáneas , Fallo Renal Crónico/sangre , Fallo Renal Crónico/complicaciones , Fallo Renal Crónico/terapia , Masculino , Persona de Mediana Edad , Estudios ProspectivosAsunto(s)
Calcio/administración & dosificación , Fallo Renal Crónico/mortalidad , Diálisis Renal/mortalidad , Calcificación Vascular/metabolismo , Administración Oral , Humanos , Factores de Riesgo , Tasa de Supervivencia , Calcificación Vascular/etiología , Calcificación Vascular/prevención & controlRESUMEN
BACKGROUND: The prevalence of water-soluble vitamin use among hemodialysis (HD) patients and whether mortality and hospitalization are associated with water-soluble vitamin use by HD patients have not previously been reported. The present study investigates patterns of water-soluble vitamin use among HD patients in the Dialysis Outcomes and Practice Patterns Study (DOPPS) I and evaluates outcomes associated with vitamin use. METHODS: The study sample came from the DOPPS I, a prospective observational study of adult HD patients (N = 16,345) randomly selected from 308 representative dialysis facilities in France, Germany, Italy, Japan, Spain, the United Kingdom, and the United States. Time-dependent Cox regression models were used to assess relative risk (RR) for mortality and hospitalization for patients administered water-soluble vitamins versus those not administered water-soluble vitamins. RESULTS: There was large variation by region in the percentage of patients administered water-soluble vitamins: Europe ranged from a low of 3.7% in the United Kingdom to a high of 37.9% in Spain; 5.6% in Japan; and 71.9% in the United States. Patient use of water-soluble vitamins was associated with a substantially and significantly lower risk for mortality (RR, 0.84; P = 0.001). Lower RR for facility-level mortality also was associated with greater water-soluble vitamin use (RR, 0.98; P = 0.05 per 10% more patients administered water-soluble vitamins at the facility). CONCLUSION: Although only a randomized trial could prove that water-soluble vitamins improve outcomes, use of water-soluble vitamins is a minimal-risk practice pattern associated with improved outcomes in this prospective observational study.
Asunto(s)
Prescripciones de Medicamentos/estadística & datos numéricos , Pautas de la Práctica en Medicina/estadística & datos numéricos , Diálisis Renal/mortalidad , Vitaminas/administración & dosificación , Adulto , Anciano , Proteínas Sanguíneas/análisis , Utilización de Medicamentos/estadística & datos numéricos , Europa (Continente)/epidemiología , Femenino , Hospitalización/estadística & datos numéricos , Humanos , Japón/epidemiología , Masculino , Persona de Mediana Edad , Modelos de Riesgos Proporcionales , Estudios Prospectivos , Riesgo , Muestreo , Solubilidad , Resultado del Tratamiento , Estados Unidos/epidemiología , Vitaminas/química , AguaRESUMEN
BACKGROUND: Anemia is common in hemodialysis (HD) patients. METHODS: Data collected from nationally representative samples of HD patients (n = 11,041) in 2002 to 2003 were used to describe current anemia management for long-term HD patients at 309 dialysis units in 12 countries. Analyses of associations and outcomes were adjusted for demographics, 15 comorbid classes, laboratory values, country, and facility clustering. RESULTS: For patients on dialysis therapy for longer than 180 days, 23% to 77% had a hemoglobin (Hgb) concentration less than 11 g/dL (<110 g/L), depending on country; 83% to 94% were administered erythropoietin (EPO). Mean Hgb levels were 12 g/dL (120 g/L) in Sweden; 11.6 to 11.7 g/dL (116 to 117 g/L) in the United States, Spain, Belgium, and Canada; 11.1 to 11.5 g/dL (111 to 115 g/L) in Australia/New Zealand, Germany, Italy, the United Kingdom, and France; and 10.1 g/dL (101 g/L) in Japan. Hgb levels were substantially lower for new patients with end-stage renal disease, and EPO use before ESRD ranged from 27% (United States) to 65% (Sweden). By patient, EPO use significantly declined with greater Hgb concentration (adjusted odds ratio, 0.61 per 1-g/dL [10-g/L] greater Hgb level; P < 0.0001), as did EPO dosage. Case-mix-adjusted mortality and hospitalization risk declined by 5% and 6% per 1-g/dL greater patient baseline Hgb level (P < or = 0.003 each), respectively. Furthermore, patient mortality and hospitalization risks were 10% to 12% lower for every 1-g/dL greater facility mean Hgb level. Patients were significantly more likely to have Hgb levels of 11 g/dL or greater (> or =110 g/L) if they were older; were men; had polycystic kidney disease; had greater albumin, transferrin saturation, or calcium levels; were not dialyzing with a catheter; or had lower ferritin levels. Facilities with greater intravenous iron use showed significantly greater facility mean Hgb concentrations. Mean EPO dose varied from 5,297 (Japan) to 17,360 U/wk (United States). Greater country mean EPO doses were significantly associated with greater country mean Hgb concentrations. Several patient characteristics were associated with greater EPO doses. Even in some countries with high intravenous iron use, 35% to 40% of patients had a transferrin saturation less than 20% (below guidelines). CONCLUSION: These findings indicate large international variations in anemia management, with significant improvements during the last 5 years, although many patients remain below current anemia guidelines, suggesting large and specific opportunities for improvement.
Asunto(s)
Anemia/tratamiento farmacológico , Eritropoyetina/administración & dosificación , Hierro/administración & dosificación , Pautas de la Práctica en Medicina/estadística & datos numéricos , Diálisis Renal/efectos adversos , Anemia/etiología , Anemia/metabolismo , Anemia/mortalidad , Australasia , Canadá , Europa (Continente) , Hemoglobinas/análisis , Hospitalización/estadística & datos numéricos , Humanos , Inyecciones Intravenosas , Masculino , Tasa de Supervivencia , Resultado del Tratamiento , Estados UnidosRESUMEN
BACKGROUND AND AIM OF THE STUDY: Valvular calcification is common in patients with end-stage renal disease, and is associated with an unfavorable prognosis. It was hypothesized that sevelamer, a non-calcium-based phosphorus binder, might attenuate the progression of valvular calcification. METHODS: Two hundred subjects on maintenance hemodialysis received either sevelamer or calcium-based phosphorus binders. To assess the extent of calcification, 186 subjects underwent baseline electron beam tomography (EBT) of the coronary arteries, aorta and mitral and aortic valves, and 132 had follow up EBT scans at week 52. Changes in valvular calcification and combined valvular/vascular calcification were monitored and compared. RESULTS: At baseline, mitral valve calcification was seen in 46% of subjects, aortic valve calcification in 33%. Most subjects with zero values at baseline failed to progress over one year. Aortic valve calcification was significantly increased in calcium-treated subjects. Changes in mitral valve calcification, and combined mitral + aortic valve calcification were less in sevelamer-treated than in calcium-treated subjects, but not significantly so. When combining valvular and vascular calcification, the median (10%, 90%) change in sevelamer-treated subjects was significantly lower than in calcium-treated subjects (6, -5084 to 1180 versus 81, -1150 to 2944, p = 0.04). The effect of sevelamer remained significant after adjustment for baseline calcification and the time-averaged calcium-phosphorus product, and was independent of the calcium preparation (acetate versus carbonate), geographic region (US versus Europe), LDL- or HDL-cholesterol, C-reactive protein and statin use. Significantly more sevelamer-treated subjects experienced an arrest (45 versus 28%, p = 0.047) or regression (26 versus 10%, p = 0.02) in total valvular and vascular calcification. CONCLUSION: Sevelamer arrested the progression of valvular and vascular calcification in almost 50% of hemodialysis subjects. Sevelamer treatment, plus intensive control of calcium and phosphorus levels, may attenuate progression of, or achieve regression in, cardiac valvular calcification.
Asunto(s)
Acetatos/uso terapéutico , Válvula Aórtica , Calcinosis/tratamiento farmacológico , Calcinosis/etiología , Carbonato de Calcio/uso terapéutico , Calcio/uso terapéutico , Enfermedades de las Válvulas Cardíacas/tratamiento farmacológico , Enfermedades de las Válvulas Cardíacas/etiología , Fallo Renal Crónico/complicaciones , Válvula Mitral , Diálisis Renal , Compuestos de Calcio , Humanos , Fallo Renal Crónico/terapia , Análisis Multivariante , Tomografía Computarizada por Rayos XRESUMEN
BACKGROUND: Rising hospital care costs have created pressure to shorten hospital stays and emphasize outpatient care. This study tests the hypothesis that shorter median length of stay (LOS) as a dialysis facility practice is associated with higher rates of early readmission. METHODS: Readmission within 30 days of each hospitalization was evaluated for participants in the Dialysis Outcomes and Practice Patterns Study, an observational study of randomly selected hemodialysis patients in the United States (142 facilities, 5095 patients with hospitalizations), five European countries (101 facilities, 2281 patients with hospitalizations), and Japan (58 facilities, 883 patients with hospitalizations). Associations between median facility LOS (estimated from all hospitalizations at the facility and interpreted as a dialysis facility practice pattern) and odds of readmission were assessed using logistic regression, adjusted for patient characteristics and the LOS of each index hospitalization. RESULTS: Risk of readmission was directly and significantly associated with LOS of the index hospitalization (adjusted odds ratio [AOR] 1.005 per day in median facility LOS, p = 0.007) and inversely associated with median facility LOS (AOR = 0.974 per day, p = 0.016). This latter association was strongest for US hemodialysis centers (AOR = 0.954 per day, p = 0.015). CONCLUSIONS: Dialysis facilities with shorter median hospital LOS for their patients have higher odds of readmission, particularly in the United States, where there is greater pressure to shorten LOS. The determinants and consequences of practices related to hospital LOS for hemodialysis patients should be further studied.
RESUMEN
BACKGROUND AND OBJECTIVES: Demand for hemodialysis among elderly patients is increasing worldwide. Although clinical care of this high-risk group is complex and challenging, no guidelines exist to inform hemodialysis practices. The Dialysis Outcomes and Practice Patterns Study (DOPPS) provides a unique opportunity to assess dialysis practices and associated outcomes among elderly versus younger patients on chronic in-center hemodialysis in 12 countries. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Clinical characteristics, dialysis practices, and outcomes of elderly versus younger patients were compared among participants in four DOPPS regions in 2005 through 2007. RESULTS: Although participant mean age increased over time in all DOPPS countries, the percentage of elderly varied widely. Overall, comorbidities and malnutrition were more common in the elderly. Fistulae were used less frequently among elderly versus younger patients in Europe and North America but not in Australia, New Zealand, and Japan. No difference in treatment time was observed between elderly and younger patients after normalizing for body weight. In all regions, ultrafiltration rates were lower among elderly patients. Elderly patients reported poorer quality of life with respect to the physical but not mental component scores. Mortality risk was three- to sixfold higher in the elderly group, whereas causes of death overall were similar for elderly and younger patients. CONCLUSIONS: Elderly patients represent a different proportion of DOPPS participants across countries, possibly reflecting differences in policies and clinical practices. In general, hemodialysis practices in the elderly reflected each region's clinical patterns, with some variation by age group depending upon the practice.
Asunto(s)
Envejecimiento , Disparidades en el Estado de Salud , Fallo Renal Crónico/terapia , Pautas de la Práctica en Medicina , Diálisis Renal , Factores de Edad , Anciano , Australia , Canadá , Comorbilidad , Europa (Continente) , Femenino , Encuestas de Atención de la Salud , Humanos , Japón , Estimación de Kaplan-Meier , Fallo Renal Crónico/diagnóstico , Fallo Renal Crónico/mortalidad , Masculino , Persona de Mediana Edad , Nueva Zelanda , Oportunidad Relativa , Evaluación de Procesos y Resultados en Atención de Salud/estadística & datos numéricos , Pautas de la Práctica en Medicina/estadística & datos numéricos , Modelos de Riesgos Proporcionales , Calidad de Vida , Diálisis Renal/efectos adversos , Diálisis Renal/mortalidad , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Estados UnidosRESUMEN
BACKGROUND: The relationship between medication prescription and sexual dysfunction (SD) in dialysis patients is unclear. METHODS: We studied antihypertensive and antidepressive agents prescribed for 7346 patients in the Dialysis Outcomes and Practice Patterns Study phase 1 (DOPPS I) and 8891 patients in DOPPS II. At baseline, DOPPS I patients completed a quality of life survey, including four questions about sexual functioning, from which we created a composite SD scale. DOPPS II patients were asked only one question about SD. We examined predictors of SD with logistic regression, using numerous patient characteristics, comorbid conditions and additional variables. RESULTS: Reported SD ranged from 66.4% (France) to 84.5% (Spain). The mean composite SD score ranged from 6.4 (Spain) to 7.9 (Germany) (on a 3-15 scale). Peripheral alpha-blockers increased odds of DOPPS I patients having their sex life bothered by end-stage renal disease (ESRD) (OR=1.18), and there were elevated odds of arousal problems with central antagonists, loop diuretics and peripheral alpha-blockers (OR=1.19, 1.24 and 1.29, respectively). Selective serotonin reuptake inhibitors (SSRIs) and benzodiazepines increased odds of problems with enjoyment (OR=1.59 and 1.26, respectively) and arousal (OR=1.70 and 1.24, respectively), and having sex life bothered by ESRD (DOPPS I: OR=1.36 and 1.24; DOPPS II: 1.30 and 1.31, respectively). Vasodilators reduced the odds of sexual enjoyment problems (OR=0.75). Composite SD scores worsened with peripheral alpha-blockers (+0.41), tricyclics (+0.78), SSRIs (+0.80) and benzodiazepines (+0.50), but not with vasodilators (-0.57). CONCLUSIONS: Awareness of associations between SD and prescribed medications may offer opportunities for intervention.
Asunto(s)
Antidepresivos/efectos adversos , Antihipertensivos/efectos adversos , Fallo Renal Crónico/terapia , Diálisis Renal , Disfunciones Sexuales Fisiológicas/inducido químicamente , Antagonistas Adrenérgicos alfa/efectos adversos , Adulto , Anciano , Antidepresivos Tricíclicos/efectos adversos , Benzodiazepinas/efectos adversos , Femenino , Francia , Alemania , Salud Global , Encuestas Epidemiológicas , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Calidad de Vida , Disfunciones Sexuales Fisiológicas/psicología , España , Vasodilatadores/efectos adversosRESUMEN
During hemodialysis, blood comes in contact with a large volume of dialysate. Since the purity of dialysate has been linked to acute and long-term complications in hemodialysis patients, the limit of bacterial and endotoxin contamination has been reduced in recent years. Questions have been raised as to whether ultrapure dialysate is required to prevent such complications; in particular, the chronic inflammatory status frequently found in chronically hemodialyzed patients. In vivo and in vitro data suggest that cytokine stimulation in the blood depends on the concentration of bacteria or endotoxin in the dialysate and on the endotoxin permeability of the dialysis membrane. It is not proven whether ultrapure dialysate reduces significantly proinflammatory cytokine generation compared with standard dialysate within the limits of recent recommendations, if rather impermeable dialysis membranes are used. Cuprophane membranes are more permeable to cytokine-inducing substances compared with synthetic membranes such as polysulfone and polyamide. Clinical reports have also attempted to link several acute and chronic complications of hemodialysis to dialysate purity. To date, however, there is no large randomized clinical trial demonstrating that ultrapure dialysate significantly reduces biomarkers of inflammation and other consequential putative complications, including dialysis-related amyloidosis, erythropoietin requirement, and cardiovascular morbidity and mortality. In conclusion, based on the existing clinical data, ultrapure dialysate is recommended in the setting of suboptimal bacteriologic quality of standard dialysate and the use of permeable dialysis membranes.
Asunto(s)
Soluciones para Diálisis/normas , Purificación del Agua , Bacterias/aislamiento & purificación , Biomarcadores , Citocinas/análisis , Endotoxinas/análisis , Humanos , Fallo Renal Crónico/terapia , Membranas ArtificialesRESUMEN
OBJECTIVE: Gout affects a large fraction of persons with advanced chronic kidney disease, and hyperuricemia may increase the risk of cardiovascular disease. Several hypouricemic agents are contraindicated in patients with end-stage renal disease. Sevelamer is a nonabsorbed hydrogel that binds phosphorus and bile acids in the intestinal tract. Results of short-term and open-label studies suggest that sevelamer might lower the concentration of uric acid, another organic anion. We undertook this study to test our hypothesis that the reduction in serum uric acid concentration induced by sevelamer would be confirmed in a long-term, randomized, clinical trial comparing sevelamer with calcium-based phosphate binders. METHODS: Two hundred subjects undergoing maintenance hemodialysis were randomly assigned to receive either sevelamer or calcium-based phosphorus binders in an international, multicenter, clinical trial. Data on baseline and end-of-study uric acid concentrations were available in 169 subjects (85%); the change in uric acid concentration from baseline to the end of the study was the outcome of interest. RESULTS: Baseline clinical characteristics, including mean uric acid concentrations, were similar in subjects randomly assigned to receive sevelamer and calcium-based phosphate binders. The mean change in uric acid concentration (from baseline to the end of the study) was significantly larger in sevelamer-treated subjects (-0.64 mg/dl versus -0.26 mg/dl; P = 0.03). The adjusted mean change in uric acid concentration was more pronounced when the effects of age, sex, diabetes, vintage (time since initiation of dialysis), dialysis dose, and changes in blood urea nitrogen and bicarbonate concentrations were considered (-0.72 mg/dl versus -0.15 mg/dl; P = 0.001). Twenty-three percent of sevelamer-treated subjects experienced a study-related reduction in the concentration of uric acid equal to -1.5 mg/dl or more, compared with 10% of calcium-treated subjects (P = 0.02). CONCLUSION: In a randomized clinical trial comparing sevelamer and calcium-based phosphate binders, treatment with sevelamer was associated with a significant reduction in serum uric acid concentrations.
Asunto(s)
Compuestos Epoxi/uso terapéutico , Fallo Renal Crónico/sangre , Fallo Renal Crónico/terapia , Proteínas de Unión a Fosfato/uso terapéutico , Polietilenos/uso terapéutico , Diálisis Renal , Ácido Úrico/sangre , Anciano , Biomarcadores/sangre , Calcio , Femenino , Humanos , Fallo Renal Crónico/tratamiento farmacológico , Masculino , Persona de Mediana Edad , Análisis Multivariante , Concentración Osmolar , Proteínas de Unión a Fosfato/química , Poliaminas , Sevelamer , Ácido Úrico/antagonistas & inhibidoresRESUMEN
BACKGROUND: We determined recently that targeted treatment with calcium-based phosphate binders (calcium acetate and carbonate) led to progressive coronary artery and aortic calcification by electron beam tomography (EBT), while treatment with the non-calcium-containing phosphate binder, sevelamer, did not. Aside from the provision of calcium, we hypothesized that other factors might be related to the likelihood of progressive calcification in both or either treatment groups. METHODS: We explored potential determinants of progressive vascular calcification in 150 randomized study subjects who underwent EBT at baseline and at least once during follow-up (week 26 or 52). RESULTS: Among calcium-treated subjects, higher time-averaged concentrations of calcium, phosphorus and the calcium-phosphorus product were associated with more pronounced increases in EBT scores; no such associations were demonstrated in sevelamer-treated subjects. The relation between parathyroid hormone (PTH) and the progression of calcification was more complex. Lower PTH was associated with more extensive calcification in calcium-treated subjects, whereas higher PTH was associated with calcification in sevelamer-treated subjects. Serum albumin was inversely correlated with progression in aortic calcification. Sevelamer was associated with favourable effects on lipids, although the link between these effects and the observed attenuation in vascular calcification remains to be elucidated. CONCLUSION: Calcium-based phosphate binders are associated with progressive coronary artery and aortic calcification, especially when mineral metabolism is not well controlled. Calcium may directly or indirectly (via PTH) adversely influence the balance of skeletal and extraskeletal calcification in haemodialysis patients.
Asunto(s)
Arteriosclerosis/epidemiología , Arteriosclerosis/etiología , Vasos Sanguíneos/patología , Calcinosis/etiología , Calcio/sangre , Compuestos Epoxi/farmacología , Fosfatos/sangre , Polietilenos/farmacología , Diálisis Renal , Anciano , Calcinosis/epidemiología , Comorbilidad , Progresión de la Enfermedad , Femenino , Humanos , Fallo Renal Crónico/epidemiología , Fallo Renal Crónico/terapia , Masculino , Hormona Paratiroidea , Poliaminas , Sevelamer , Estadísticas no Paramétricas , Tomografía Computarizada por Rayos XRESUMEN
BACKGROUND: The Dialysis Outcomes and Practice Patterns Study (DOPPS) is a prospective, observational study based on data collected from nationally representative samples of haemodialysis facilities. The burden of anaemia in haemodialysis patients is substantial, leading to considerable morbidity, mortality and reduced quality of life. This study examines anaemia management and outcomes based on data from five European countries participating in the DOPPS: France, Germany, Italy, Spain and the UK. METHODS: Baseline data on demographics, co-morbidities and anaemia management in 4591 haemodialysis patients from 101 nephrology facilities were collected in 1998-2000. Using multivariate Cox survival analyses to adjust for patient characteristics, relationships between haemoglobin concentration at study entry and rates of mortality and hospitalization were evaluated. RESULTS: For a year 2000 sample of prevalent patients on haemodialysis >180 days, mean haemoglobin concentration was 11.0 g/dl; 53% had a haemoglobin concentration > or = 11 g/dl [1998-1999 = 44% (P < 0.05)]. In 2000, 84% of prevalent patients were prescribed recombinant human erythropoietin (rHuEpo). Higher haemoglobin concentrations were associated with decreased relative risk (RR) for mortality (RR = 0.95 for every 1 g/dl higher haemoglobin, P = 0.03) and hospitalization (RR = 0.96, P = 0.02). Patients with haemoglobin <10 g/dl were 29% more likely to be hospitalized than patients with haemoglobin 11-12 g/dl (P < 0.001). CONCLUSION: Even after adjustment, lower haemoglobin concentrations were associated with higher morbidity and mortality in European haemodialysis patients. A trend to increased haemoglobin concentrations was observed following publication of the European Best Practice Guidelines (EBPG) on anaemia management for chronic kidney disease patients, but efforts must continue to achieve EBPG goals.
Asunto(s)
Anemia/mortalidad , Fallo Renal Crónico/mortalidad , Anemia/etiología , Anemia/terapia , Estudios Transversales , Eritropoyetina/uso terapéutico , Europa (Continente)/epidemiología , Femenino , Hematínicos/uso terapéutico , Humanos , Compuestos de Hierro/uso terapéutico , Fallo Renal Crónico/complicaciones , Fallo Renal Crónico/terapia , Masculino , Persona de Mediana Edad , Pautas de la Práctica en Medicina/estadística & datos numéricos , Estudios Prospectivos , Proteínas Recombinantes , Diálisis Renal/estadística & datos numéricos , Resultado del TratamientoRESUMEN
BACKGROUND: Mortality and hospitalization rates are reported for nationally representative random samples of haemodialysis patients treated at randomly selected dialysis facilities in five European countries participating in the Dialysis Outcomes and Practice Pattern Study (DOPPS) (France, Germany, Italy, Spain and the UK). RESULTS: In the UK, 28.1% of haemodialysis patients received prior peritoneal dialysis treatment compared with 4.2-8.3% in other countries. Kidney transplantation rates ranged from 3.3 (per 100 patient years) in Italy to 11.6 in Spain. The relative risk (RR) of mortality, adjusted for age, sex and diabetes status was significantly higher in the UK (RR = 1.39, P = 0.02) compared with Italy (reference) and increased in association with age (RR = 1.60 for every 10 years older, P <0.001), diabetes as cause of end-stage renal disease (ESRD) (RR = 1.55, P < 0.001), male patients <65 years (RR = 1.29, P = 0.02) and peritoneal dialysis in the 12 months prior to starting haemodialysis (RR = 1.72, P = 0.06). Hospitalization for cardiovascular disease was highest in France and Germany (0.40 and 0.43 hospitalizations per patient year, respectively) and lowest in the UK (0.19), although cardiovascular comorbidity was similar in the UK and France. Hospitalization rates for vascular access-related infection ranged from 0.01 hospitalizations per patient year in Italy to 0.08 in the UK, consistent with the higher dialysis catheter use in the UK (25%) vs Italy (5%). Hospitalization risk was significantly higher in France than in other Euro-DOPPS countries and was significantly (P < 0.05) associated with prior peritoneal dialysis therapy, peripheral vascular disease, gastrointestinal bleeding in the prior 12 months, diabetes, cancer, cardiac disease, psychiatric disease and recent onset of ESRD (within 30 days of study entry). CONCLUSIONS: The large differences in haemodialysis practice and outcomes in the Euro-DOPPS countries suggest opportunities for improvement in patient care.