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
BACKGROUND: The effectiveness of phosphate binders in daily practice is directly related to therapeutic compliance (TC) by the patient. The goal of this study was to analyse the TC of haemodialysis patients with hyperphosphatemia and its influence on serum phosphorus for 6 months follow up. METHODS: 181 patients were included, who had mean initial phosphate levels (P) >5mg/dl. TC with different phosphate binders was evaluated, considering non-adherent patients those who had <75% of TC, SMAQ scale score of "non-adherent"(Table 1), and P>5mg/dl. Patients who were adherent at baseline visit (BV) left the study, the rest continued to V5 (6 months). TC at baseline and during the follow up (V1-V5) was analysed. Phosphate binders and the evolution of phosphataemia based on treatment were assessed. RESULTS: 103 male and 78 female patients were evaluated, with a mean age of 59.9 (21-86) years. Of these, 39.2% (n=71) were adherent in the BV. Patients older than 60 years of age were more adherent than younger ones (P=.019).Table 6 specifies the causes of non-compliance. The remaining 60.8% of patients (n=110), were non-adherent and continued through to the end of the study. An average of 27.2% of these patients became adherent during the course of the study. Table 7 shows the relative levels of P with TC over successive visits. At the end of the study, mean P levels had decreased by 1.26mg/dl (P<.0001). CONCLUSION: Among HD patients with poor P level control, there is a low level of adherence with phosphorus binder treatment, at 39.2%. Compliance and phosphataemia are improved with different strategies. The decrease of P is higher in adherent patients than in non-adherent patients.
Subject(s)
Chelating Agents/therapeutic use , Hyperphosphatemia/drug therapy , Medication Adherence/statistics & numerical data , Phosphorus/metabolism , Renal Dialysis , Adult , Aged , Aged, 80 and over , Female , Follow-Up Studies , Humans , Male , Middle Aged , Prospective Studies , Surveys and Questionnaires , Young AdultABSTRACT
The authors report 2 cases of patients who underwent cadaveric renal transplantation from the same donor in a multiorgan extraction procedure. Both cases showed, during the first 6 months posttransplantation, a worsening in renal graft function and signs of ischemia in the homolateral lower limb. One of the cases was preceded by pain in the sciatic region. In imaging tests, a pseudoaneurysm was detected in the iliac artery in both patients. Grafts had to be removed, and the iliac arteries were ligated with posterior isolation of Aspergillus spp from the arterial vessels but not from the renal tissue. Besides surgery, medical treatment with liposomal amphotericin B was initiated with a different outcome in each patient: patient A died, whereas patient B recovered. The absence of Aspergillus spp infection in liver and heart recipients ruled out a donor-transmitted infection. The graft placements were carried out in different operating rooms, which rules out contamination during the transplantation process. All of this leads us to conclude that the infection must have occurred during the preservation phase of the kidney.
