ABSTRACT
BACKGROUND: Most people who make the transition to renal replacement therapy (RRT) are treated with a fixed dose thrice-weekly hemodialysis réegimen, without considering their residual kidney function (RKF). Recent papers inform us that incremental hemodialysis is associated with preservation of RKF, whenever compared with conventional hemodialysis. The objective of the present controlled randomized trial (RCT) is to determine if start HD with one sessions per week (1-Wk/HD), it is associated with better patient survival and other safety parameters. METHODS/DESIGN: IHDIP is a multicenter RCT experimental open trial. It is randomized in a 1:1 ratio and controlled through usual clinical practice, with a low intervention level and non-commercial. It includes 152 incident patients older than 18 years, with a RRF of ≥4 ml/min/1.73 m2, measured by renal clearance of urea (KrU). The intervention group includes 76 patients who will start with incremental HD (1-Wk/HD). The control group includes 76 patients who will start with thrice-weekly hemodialysis régimen. The primary outcome is assessing the survival rate, while the secondary outcomes are the morbidity rate, the clinical parameters, the quality of life and the efficiency. DISCUSSION: This study will enable to know the number of sessions a patient should receive when starting HD, depending on his RRF. The potentially important clinical and financial implications of incremental hemodialysis warrant this RCT. TRIAL REGISTRATION: U.S. National Institutes of Health, ClinicalTrials.gov . Number: NCT03239808 , completed 13/04/2017. SPONSOR: Foundation for Training and Research of Health Professionals of Extremadura.
Subject(s)
Kidney/physiopathology , Multicenter Studies as Topic/methods , Randomized Controlled Trials as Topic/methods , Renal Dialysis/methods , Creatinine/urine , Humans , Outcome Assessment, Health Care , Prospective Studies , Renal Dialysis/adverse effects , Urea/metabolismABSTRACT
INTRODUCCIÓN: La hemodiálisis (HD) progresiva es una modalidad de inicio del tratamiento renal sustitutivo adaptada a las necesidades individuales de cada paciente. Está condicionada fundamentalmente por la función renal residual (FRR). En ella, la frecuencia de sesiones con las que el paciente inicia HD (una o 2 sesiones por semana) es menor que en la HD convencional (3 por semana). Dicha frecuencia aumenta (de una a 2, y de 2 a 3) con el declinar de la FRR. Metodología/diseño: DiPPI es un estudio abierto, multicéntrico, experimental, aleatorizado 1:1 y controlado con procedimiento de práctica clínica habitual, de bajo nivel de intervención y no comercial. Incluye 152 pacientes mayores de 18 años, con enfermedad renal crónica estadio 5, que inician HD como tratamiento renal sustitutivo; y la FRR, medida por aclaramiento renal de urea (KrU) es ≥ 4ml/min/1,73 m2. El estudio se basa en un grupo de intervención con 76 pacientes que iniciarán HD con una sola sesión por semana (modalidad progresiva) y un grupo control con 76 pacientes que comenzarán con 3 sesiones por semana. El objetivo primario es evaluar la supervivencia y los objetivos secundarios son la morbilidad (hospitalizaciones), los parámetros clínicos habituales, la calidad de vida y la eficiencia. DISCUSIÓN: Este estudio permitirá conocer, con la máxima evidencia científica, cuántas sesiones debe recibir un paciente al inicio del tratamiento con HD, dependiendo de su FRR. Registro: Registrado en U.S. National Institutes of Health, ClinicalTrials.gov con número NCT03239808
INTRODUCTION: Progressive haemodialysis (HD) is a starting regime for renal replacement therapy (RRT) adapted to each patient's necessities. It is mainly conditioned by the residual renal function (RRF). The frequency of sessions with which patients start HD (one or two sessions per week), is lower than that for conventional HD (three times per week). Such frequency is increased (from one to two sessions, and from two to three sessions) as the RRF declines. Methodology/DESIGN: IHDIP is a multicentre randomised experimental open trial. It is randomised in a 1:1 ratio and controlled through usual clinical practice, with a low intervention level and non-commercial. It includes 152 patients older than 18 years with chronic renal disease stage 5 and start HD as RRT, with an RRF of ≥ 4 ml/min/1.73 m2, measured by renal clearance of urea (KrU). The intervention group includes 76 patients who will start with one session of HD per week (progressive HD). The control group includes 76 patients who will start with three sessions per week (conventional HD). The primary purpose is assessing the survival rate, while the secondary purposes are the morbidity rate (hospital admissions), the clinical parameters, the quality of life and the efficiency. DISCUSSION: This study will enable us to know, with the highest level of scientific evidence, the number of sessions a patient should receive when starting the HD treatment, depending on his/her RRF. Trial registration: Registered at the U.S. National Institutes of Health, ClinicalTrials.gov under the number NCT03239808
Subject(s)
Humans , Aged , Renal Insufficiency, Chronic/therapy , 50303 , Renal Dialysis/methods , Case-Control Studies , Treatment Outcome , Quality of LifeABSTRACT
INTRODUCTION: Progressive haemodialysis (HD) is a starting regime for renal replacement therapy (RRT) adapted to each patient's necessities. It is mainly conditioned by the residual renal function (RRF). The frequency of sessions with which patients start HD (one or two sessions per week), is lower than that for conventional HD (three times per week). Such frequency is increased (from one to two sessions, and from two to three sessions) as the RRF declines. METHODOLOGY/DESIGN: IHDIP is a multicentre randomised experimental open trial. It is randomised in a 1:1 ratio and controlled through usual clinical practice, with a low intervention level and non-commercial. It includes 152 patients older than 18 years with chronic renal disease stage 5 and start HD as RRT, with an RRF of ≥4ml/min/1.73m2, measured by renal clearance of urea (KrU). The intervention group includes 76 patients who will start with one session of HD per week (progressive HD). The control group includes 76 patients who will start with three sessions per week (conventional HD). The primary purpose is assessing the survival rate, while the secondary purposes are the morbidity rate (hospital admissions), the clinical parameters, the quality of life and the efficiency. DISCUSSION: This study will enable us to know, with the highest level of scientific evidence, the number of sessions a patient should receive when starting the HD treatment, depending on his/her RRF. TRIAL REGISTRATION: Registered at the U.S. National Institutes of Health, ClinicalTrials.gov under the number NCT03239808.
Subject(s)
Kidney Failure, Chronic/therapy , Renal Dialysis/methods , Aged , Humans , Prospective Studies , Renal Dialysis/adverse effects , Research Design , Treatment OutcomeABSTRACT
El manejo del cáncer de seno es multidisciplinario e involucra la cirugía, la quimioterapia, la radioterapia y la hormonoterapia. La hormonoterapia es un tratamiento muy antiguo para el manejo efectivo del cáncer de seno hormono-sensible. Cerca de 75 porciento de las pacientes expresan receptores hormonales en el tumor y el estándar de manejo ha sido con antiestrógenos como el tamoxifeno, que se viene usando desde hace más de 25 años en ensayos clínicos con buena respuesta, mejorando la supervivencia libre de enfermedad (SLE) y la supervivencia total (ST) de las pacientes, tanto en mujeres premenopáusicas como postmenopáusicas; por los efectos secundarios sobre endometrio y coagulación, se han venido desarrollando nuevas drogas llamadas inhibidores de aromatasa, que han sido comparados con el tamoxifeno en el estado metastásico y en adyuvancia, con mejores resultados de supervivencia libre de enfermedad con menos efectos secundarios sobre endometrio y menos eventos trombóticos, aunque aumentan el riesgo de osteoporosis y fracturas con su uso prolongado.
Subject(s)
Humans , Antineoplastic Agents, Hormonal , Breast Neoplasms , Chemotherapy, Adjuvant , Receptors, EstrogenABSTRACT
BACKGROUND: Daily dialysis has shown excellent clinical results because a higher frequency of dialysis is more physiologic. On-line hemodiafiltration (OL-HDF) is a HDF technique that combines diffusion with high convection in which the dialysis fluid itself is used as a reinfusion solution. The aim of this study was to demonstrate the beneficial effect of the more effective dialysis schedule (daily dialysis) with the dialysis modality that offers the highest uremic toxin removal (on-line HDF). METHODS: Eight patients, six males and two females, on standard 4 to 5 hours three times a week OL-HDF (S-OL-HDF) were switched to daily OL-HDF (D-OL-HDF) 2 to 21/2 hours six times per week. Dialysis parameters were identical during both periods and only frequency and dialysis time of each session were changed. Tolerance, uremic toxin removal, urea kinetics, biochemical and anemia profiles, blood pressure, and left ventricular hypertrophy were evaluated. RESULTS: D-OL-HDF was well accepted and tolerated. The disappearance of postdialysis fatigue was rapidly reported by patients. Patients mantained the same [time average concentration (TAC) and weekly single-pool Kt/V (spKt/V)] throughout the study. However, equivalent renal urea clearance (EKR), standard Kt/V and weekly urea reduction ratio (URR) were increased during D-OL-HDF. Weekly urea, creatinine, osteocalcin, beta2-microglobulin, myoglobin, and prolactin reduction ratios were improved with D-OL-HDF. There was a significant decrease in predialysis plasma levels of urea, creatinine, acid uric, beta2-microglobulin and homocysteine over 6 months. Phosphate binders were reduced and antihypertensive drugs were stopped. A 30% regression of left ventricular mass was observed. CONCLUSION: The change from S-OL-HDF to D-OL-HDF was well tolerated. Disappearance of postdialysis fatigue, better dialysis adequacy, a higher removal of middle and large molecules, a reduction of phosphate binders, improvement of status nutritional, and an important reduction of cardiovascular risk factors were observed.
Subject(s)
Hemodiafiltration , Kidney Diseases/therapy , Adult , Aged , Blood Pressure , Blood Urea Nitrogen , Female , Heart/physiopathology , Humans , Hypertrophy, Left Ventricular/diagnosis , Kidney Diseases/physiopathology , Kinetics , Magnetic Resonance Imaging , Male , Middle Aged , Nutritional Physiological Phenomena , Population Surveillance , Single-Blind Method , Time Factors , Treatment OutcomeABSTRACT
BACKGROUND: Removal of medium and large solutes is poor with low-flux (LF-HD) and limited with high-flux hemodialysis (HF-HD) and on-line hemodiafiltration (OL-HDF). In clinical practice, there are few in vivo solute markers. Osteocalcin is a protein with a molecular mass of 5,800 daltons, and myoglobin is a large molecule with a molecular mass of 17,200 daltons. The aim of this study was to evaluate the impact of OL-HDF on in vivo removal of a wide spectrum of solutes (urea, creatinine, osteocalcin, beta2-microglobulin, and myoglobin) in comparison to LF-HD and HF-HD. METHODS: Twenty-three patients (15 men, 8 women) were studied. Every patient underwent three dialysis sessions with routine HD parameters. We compared 1.8-m2 polysulfone LF-HD and 1.8-m2 polysulfone HF-HD versus OL-HDF. Predialysis and postdialysis solute concentrations were measured. The percentage of reduction ratio for each solute was calculated. RESULTS: Mean values for predialysis osteocalcin, beta2-microglobulin, and myoglobin were 16.3 +/- 21 ng/mL, 27.4 +/- 5 mg/L, and 239 +/- 162 ng/mL in LF-HD, respectively. Urea and creatinine reduction ratios were similar in LF-HD and HF-HD and only 1.2% higher in OL-HDF. Osteocalcin, beta2-microglobulin, and myoglobin reduction ratios for LF-HD were negligible. Mean osteocalcin reduction rates were 54.2% +/- 12% for HF-HD versus 63.5% +/- 9% for OL-HDF (reinfusion volume, 26.8 +/- 5 L/session; P < 0.01). Mean beta2-microglobulin reduction rates were 60.1% +/- 9% for HF-HD versus 75.4% +/- 9% for OL-HDF (P < 0.01). Mean myoglobin reduction rates were 24.5% +/- 6% and 62.7% +/- 9% for HF-HD and OL-HDF, respectively (P < 0.01). CONCLUSION: LF-HD does not seem to remove solutes with a molecular weight greater than 5,800 daltons. OL-HDF provides marked enhancement of convection volume and enables a significant increase in osteocalcin and beta2-microglobulin removal. Myoglobin extraction is nil with LF-HD, very low with HF-HD, and only adequate with OL-HDF.
