RESUMEN
BACKGROUND: Diabetes, end stage renal disease (ESRD), and peripheral arterial disease (PAD) are associated with a higher risk of diabetes-related lower limb amputation. Timely identification of PAD with toe systolic blood pressure (TSBP) and toe-brachial pressure index (TBPI) is critical in order to implement foot protection strategies to prevent foot complications in people with ESRD. There is limited evidence describing the effect of haemodialysis on TSBP and TBPI. This study aimed to determine the variability of TSBP and TBPI during haemodialysis in people with ESRD, and to determine whether any observed variability differed between people with and without diabetes. METHODS: TSBP and TBPI were taken before dialysis (T1), one hour into dialysis (T2) and in the last 15 min of dialysis (T3) during a single dialysis session. Linear mixed effects models were undertaken to determine the variability in TSBP and TBPI across the three time points and to determine whether this variability differed between people with and without diabetes. RESULTS: Thirty participants were recruited, including 17 (57%) with diabetes and 13 (43%) with no diabetes. A significant overall reduction in TSBP was observed across all participants (P < 0.001). There was a significant reduction in TSBP between T1 and T2 (P < 0.001) and between T1 and T3 (P < 0.001). There was no significant overall change in TBPI over time (P = 0.62). There was no significant overall difference in TSBP between people with diabetes and people with no diabetes (mean difference [95% CI]: -9.28 [-40.20, 21.64], P = 0.54). There was no significant overall difference in TBPI between people with diabetes and people with no diabetes (mean difference [95% CI]: -0.01 [-0.17, 03.16], P = 0.91). CONCLUSION: TSBP and TBPI are an essential part of vascular assessment of the lower limb. TBPI remained stable and TSBP significantly reduced during dialysis. Given the frequency and duration of dialysis, clinicians taking toe pressures to screen for PAD should be aware of this reduction and consider how this may have an impact on wound healing capacity and the development of foot related complications.
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Diabetes Mellitus , Fallo Renal Crónico , Enfermedad Arterial Periférica , Humanos , Proyectos Piloto , Extremidad Inferior , Dedos del Pie , Diálisis Renal , Fallo Renal Crónico/terapiaRESUMEN
BACKGROUND AND OBJECTIVES: The Initiating Dialysis Early and Late study showed that planned early or late initiation of dialysis, based on the Cockcroft and Gault estimation of GFR, was associated with identical clinical outcomes. This study examined the association of all-cause mortality with estimated GFR at dialysis commencement, which was determined using multiple formulas. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Initiating Dialysis Early and Late trial participants were stratified into tertiles according to the estimated GFR measured by Cockcroft and Gault, Modification of Diet in Renal Disease, or Chronic Kidney Disease-Epidemiology Collaboration formula at dialysis commencement. Patient survival was determined using multivariable Cox proportional hazards model regression. RESULTS: Only Initiating Dialysis Early and Late trial participants who commenced on dialysis were included in this study (n=768). A total of 275 patients died during the study. After adjustment for age, sex, racial origin, body mass index, diabetes, and cardiovascular disease, no significant differences in survival were observed between estimated GFR tertiles determined by Cockcroft and Gault (lowest tertile adjusted hazard ratio, 1.11; 95% confidence interval, 0.82 to 1.49; middle tertile hazard ratio, 1.29; 95% confidence interval, 0.96 to 1.74; highest tertile reference), Modification of Diet in Renal Disease (lowest tertile hazard ratio, 0.88; 95% confidence interval, 0.63 to 1.24; middle tertile hazard ratio, 1.20; 95% confidence interval, 0.90 to 1.61; highest tertile reference), and Chronic Kidney Disease-Epidemiology Collaboration equations (lowest tertile hazard ratio, 0.93; 95% confidence interval, 0.67 to 1.27; middle tertile hazard ratio, 1.15; 95% confidence interval, 0.86 to 1.54; highest tertile reference). CONCLUSION: Estimated GFR at dialysis commencement was not significantly associated with patient survival, regardless of the formula used. However, a clinically important association cannot be excluded, because observed confidence intervals were wide.
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Tasa de Filtración Glomerular , Enfermedades Renales/diagnóstico , Enfermedades Renales/terapia , Riñón/fisiopatología , Modelos Biológicos , Diálisis Renal , Australia/epidemiología , Humanos , Estimación de Kaplan-Meier , Enfermedades Renales/mortalidad , Enfermedades Renales/fisiopatología , Análisis Multivariante , Valor Predictivo de las Pruebas , Modelos de Riesgos Proporcionales , Diálisis Renal/efectos adversos , Diálisis Renal/mortalidad , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Abnormalities of cardiac structure and function are common in patients undergoing dialysis, and cardiovascular disease is the major cause of mortality in this group. Heart failure is a common clinical manifestation of cardiovascular disease and is preceded by left ventricular hypertrophy (LVH). There are variable reports about the impact of dialysis on LVH, both deleterious and beneficial. Our study investigated whether the timing of the initiation of dialysis therapy had an impact on cardiac structure and function. STUDY DESIGN: Randomized controlled trial. SETTING & PARTICIPANTS: This is a cardiac substudy involving 182 patients with stage 5 chronic kidney disease in the IDEAL (Initiating Dialysis Early and Late) trial. INTERVENTION: The IDEAL trial randomly assigned patients on the basis of estimated glomerular filtration rate (eGFR), calculated using the Cockcroft-Gault equation, to start dialysis therapy early (GFR, 10-14 mL/min/1.73 m(2)), with the others starting late (GFR, 5-7 mL/min/1.73 m(2)). OUTCOMES & MEASUREMENTS: Echocardiograms were obtained at baseline and 12 months after randomization. Primary outcomes were change in left ventricular mass indexed for height (LVMi) between baseline and 12 months, left ventricular ejection fraction, left ventricular systolic annular velocity, ratio of mitral inflow velocity (E) to mitral annular velocity (Ea) (E/Ea), and left atrial volume indexed for height (LAVi). RESULTS: LVMi at baseline was elevated, but similar in both groups, with no significant change within or between groups at 12 months. E/Ea and LAVi were increased at baseline, consistent with significant diastolic dysfunction; there were no differences between groups at 12 months and no changes were observed for left ventricular volumes, left ventricular ejection fraction, stroke volume, and other echocardiographic parameters. LIMITATIONS: Small multicenter study using echocardiography. CONCLUSIONS: Advanced cardiac disease in these patients with stage 5 chronic kidney disease did not progress during the 12-month study period and planned early initiation of dialysis therapy did not result in differences in any echocardiographic variables of cardiac structure and function.
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Ecocardiografía , Corazón/fisiopatología , Diálisis Renal , Intervención Médica Temprana , Femenino , Humanos , Masculino , Persona de Mediana EdadRESUMEN
BACKGROUND: Since the mid-1990s, early dialysis initiation has dramatically increased in many countries. The Initiating Dialysis Early and Late (IDEAL) study demonstrated that, compared with late initiation, planned early initiation of dialysis was associated with comparable clinical outcomes and increased health care costs. Because residual renal function is a key determinant of outcome and is better preserved with peritoneal dialysis (PD), the present pre-specified subgroup analysis of the IDEAL trial examined the effects of early-compared with late-start dialysis on clinical outcomes in patients whose planned therapy at the time of randomization was PD. METHODS: Adults with an estimated glomerular filtration rate (eGFR) of 10 - 15 mL/min/1.73 m(2) who planned to be treated with PD were randomly allocated to commence dialysis at an eGFR of 10 - 14 mL/min/1.73 m(2) (early start) or 5 - 7 mL/min/1.73 m(2) (late start). The primary outcome was all-cause mortality. RESULTS: Of the 828 IDEAL trial participants, 466 (56%) planned to commence PD and were randomized to early start (n = 233) or late start (n = 233). The median times from randomization to dialysis initiation were, respectively, 2.03 months [interquartile range (IQR):1.67 - 2.30 months] and 7.83 months (IQR: 5.83 - 8.83 months). Death occurred in 102 early-start patients and 96 late-start patients [hazard ratio: 1.04; 95% confidence interval (CI): 0.79 - 1.37]. No differences in composite cardiovascular events, composite infectious deaths, or dialysis-associated complications were observed between the groups. Peritonitis rates were 0.73 episodes (95% CI: 0.65 - 0.82 episodes) per patient-year in the early-start group and 0.69 episodes (95% CI: 0.61 - 0.78 episodes) per patient-year in the late-start group (incidence rate ratio: 1.19; 95% CI: 0.86 - 1.65; p = 0.29). The proportion of patients planning to commence PD who actually initiated dialysis with PD was higher in the early-start group (80% vs 70%, p = 0.01). CONCLUSION: Early initiation of dialysis in patients with stage 5 chronic kidney disease who planned to be treated with PD was associated with clinical outcomes comparable to those seen with late dialysis initiation. Compared with early-start patients, late-start patients who had chosen PD as their planned dialysis modality were less likely to commence on PD.
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Fallo Renal Crónico/terapia , Diálisis Peritoneal , Anciano , Femenino , Tasa de Filtración Glomerular , Humanos , Análisis de Intención de Tratar , Estimación de Kaplan-Meier , Fallo Renal Crónico/mortalidad , Fallo Renal Crónico/fisiopatología , Masculino , Persona de Mediana Edad , Peritonitis/epidemiología , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: In clinical practice there is considerable variation in the timing of initiation of dialysis. The IDEAL trial (Initiating Dialysis Early and Late study) showed that planned early initiation of dialysis in patients with stage 5 chronic kidney disease (CKD) was not associated with an improvement in clinical outcome, but was associated with increased costs. The predominant dialysis modality worldwide is hemodialysis (HD). This subanalysis of the IDEAL trial examined whether the timing of the initiation of dialysis in those who had chosen HD influenced survival and the occurrence of complications. METHODS: Patients on the IDEAL trial were older than 18 years and had progressive advanced CKD. They were randomly assigned to commence dialysis at an estimated glomerular filtration rate (eGFR) of 10-14 ml/min (early start) or when the eGFR was 5-7 ml/min (late start). The primary outcome was death from any cause. RESULTS: Between 2000 and 2008, 362 of the 828 patients (43.7%) randomized in the trial planned to commence HD. 322 (88.9%) of these subsequently commenced HD and 17 (4.7%) commenced peritoneal dialysis, with a median time to the initiation of dialysis of 1.63 months in the early-start group and 6.93 months in the late- start group. During a median follow-up time of 3.81 years, 50 of 171 patients in the early-start group (29.2%) and 59 in the late-start group (30.1%) died (hazard ratio with early initiation=0.97: 95% CI: 0.66-1.41; p=0.86). There was no significant difference in the frequency of cardiovascular events, infections, or access-related events, but there was a significantly higher frequency of fluid and electrolyte events in the late-start group (p=0.02). CONCLUSION: In this subanalysis of the IDEAL trial, patients commencing dialysis early with stage 5 CKD for whom the planned dialysis modality was HD did not have an improvement in survival or any reduction in most clinical outcomes apart from fluid and electrolyte events.
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Enfermedades Renales/terapia , Diálisis Renal , Adulto , Anciano , Enfermedad Crónica , Femenino , Tasa de Filtración Glomerular , Humanos , Enfermedades Renales/mortalidad , Enfermedades Renales/fisiopatología , Masculino , Persona de Mediana Edad , Resultado del TratamientoRESUMEN
BACKGROUND: Planned early initiation of dialysis therapy based on estimated kidney function does not influence mortality and major comorbid conditions, but amelioration of symptoms may improve quality of life and decrease costs. STUDY DESIGN: Patients with progressive chronic kidney disease and a Cockcroft-Gault estimated glomerular filtration rate of 10-15 mL/min/1.73 m(2) were randomly assigned to start dialysis therapy at a glomerular filtration rate of either 10-14 (early start) or 5-7 mL/min/1.73 m(2) (late start). SETTING & POPULATION: Of the original 828 patients in the IDEAL (Initiation of Dialysis Early or Late) Trial in renal units in Australia and New Zealand, 642 agreed to participate in this cost-effectiveness study. STUDY PERSPECTIVE & TIMEFRAME: A societal perspective was taken for costs. Patients were enrolled between July 1, 2000, and November 14, 2008, and followed up until November 14, 2009. INTERVENTION: Planned earlier start of maintenance dialysis therapy. OUTCOMES: Difference in quality of life and costs. RESULTS: Median follow-up of patients (307 early start, 335 late start) was 4.15 years, with a 6-month difference in median duration of dialysis therapy. Mean direct dialysis costs were significantly higher in the early-start group ($10,777; 95% CI, $313 to $22,801). Total costs, including costs for resources used to manage adverse events, were higher in the early-start group ($18,715; 95% CI, -$3,162 to $43,021), although not statistically different. Adjusted for differences in baseline quality of life, the difference in quality-adjusted survival between groups over the time horizon of the trial was not statistically different (0.02 full health equivalent years; 95% CI, -0.09 to 0.14). LIMITATIONS: Missing quality-of-life questionnaires and skewed cost data, although similar in each group, decrease the precision of results. CONCLUSION: Planned early initiation of dialysis therapy in patients with progressive chronic kidney disease has higher dialysis costs and is not associated with improved quality of life.
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Fallo Renal Crónico/economía , Fallo Renal Crónico/terapia , Diálisis Renal/economía , Anciano , Análisis Costo-Beneficio , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Diálisis Renal/métodos , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: In clinical practice, there is considerable variation in the timing of the initiation of maintenance dialysis for patients with stage V chronic kidney disease, with a worldwide trend toward early initiation. In this study, conducted at 32 centers in Australia and New Zealand, we examined whether the timing of the initiation of maintenance dialysis influenced survival among patients with chronic kidney disease. METHODS: We randomly assigned patients 18 years of age or older with progressive chronic kidney disease and an estimated glomerular filtration rate (GFR) between 10.0 and 15.0 ml per minute per 1.73 m2 of body-surface area (calculated with the use of the Cockcroft-Gault equation) to planned initiation of dialysis when the estimated GFR was 10.0 to 14.0 ml per minute (early start) or when the estimated GFR was 5.0 to 7.0 ml per minute (late start). The primary outcome was death from any cause. RESULTS: Between July 2000 and November 2008, a total of 828 adults (mean age, 60.4 years; 542 men and 286 women; 355 with diabetes) underwent randomization, with a median time to the initiation of dialysis of 1.80 months (95% confidence interval [CI], 1.60 to 2.23) in the early-start group and 7.40 months (95% CI, 6.23 to 8.27) in the late-start group. A total of 75.9% of the patients in the late-start group initiated dialysis when the estimated GFR was above the target of 7.0 ml per minute, owing to the development of symptoms. During a median follow-up period of 3.59 years, 152 of 404 patients in the early-start group (37.6%) and 155 of 424 in the late-start group (36.6%) died (hazard ratio with early initiation, 1.04; 95% CI, 0.83 to 1.30; P=0.75). There was no significant difference between the groups in the frequency of adverse events (cardiovascular events, infections, or complications of dialysis). CONCLUSIONS: In this study, planned early initiation of dialysis in patients with stage V chronic kidney disease was not associated with an improvement in survival or clinical outcomes. (Funded by the National Health and Medical Research Council of Australia and others; Australian New Zealand Clinical Trials Registry number, 12609000266268.)
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Fallo Renal Crónico/terapia , Diálisis Renal/métodos , Adulto , Enfermedades Cardiovasculares/etiología , Enfermedades Cardiovasculares/mortalidad , Femenino , Estudios de Seguimiento , Tasa de Filtración Glomerular , Humanos , Infecciones/etiología , Infecciones/mortalidad , Estimación de Kaplan-Meier , Fallo Renal Crónico/complicaciones , Fallo Renal Crónico/mortalidad , Masculino , Persona de Mediana Edad , Modelos de Riesgos Proporcionales , Calidad de Vida , Diálisis Renal/efectos adversos , Factores de Tiempo , Uremia/etiologíaRESUMEN
OBJECTIVES: The primary objective of the IDEAL study is to determine whether the timing of dialysis initiation has an effect on survival in subjects with end-stage renal disease (ESRD). The secondary objectives are to determine the impact of "early start" versus "late start" dialysis on nutritional and cardiac morbidity, quality of life, and economic cost. DESIGN: Prospective multicenter randomized controlled trial. Patients are randomized to commence dialysis at a glomerular filtration rate (by Cockcroft-Gault) of either 10-14 mL/minute/1.73 m2 ("early start") or 5-7 mL/min/1.73 m2 ("late start"), with stratification for dialysis modality (hemodialysis vs peritoneal dialysis), study center, and the presence or not of diabetes mellitus. SETTING: Dialysis units throughout Australia and New Zealand. PATIENTS: Patients with ESRD commencing chronic dialysis therapy. OUTCOME MEASURES: Three years from randomization, all-cause mortality, morbidity, and economic impact; structural and functional cardiac status, nutritional state, and quality of life will be assessed. RESULTS: To date, 388 patients of a minimum 800 patients have been entered and randomized into the study. Current recruitment rates suggest sufficient patients will be enrolled by December 2004 and follow-up completed by December 2007. CONCLUSIONS: The IDEAL study will provide evidence for the optimal time to commence dialysis.