Suárez Miguel A, García-Cabrera Emilio, Gascón Antonio, López Francisca, Torregrosa Eduardo, García Giannina E, Huertas Jorge, de la Flor José C, Puello Suleyka, Gómez-Raja Jonathan, Grande Jesús, Lerma José L, Corradino Carlos, Ramos Manuel, Martín Jesús, Basile Carlo, Casino Francesco G, Deira Javier
Unidad de Nefrología, Hospital Virgen del Puerto, Plasencia, España.
Delos Clinical Research Organization, Sevilla, España.
Nefrologia (Engl Ed). 2018 Nov-Dec;38(6):630-638. doi: 10.1016/j.nefro.2018.07.010. Epub 2018 Oct 19.
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/1.73m, 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.
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.
Registered at the U.S. National Institutes of Health, ClinicalTrials.gov under the number NCT03239808.
渐进性血液透析（HD）是一种根据每位患者需求调整的肾脏替代治疗（RRT）起始方案。它主要取决于残余肾功能（RRF）。患者开始进行HD的频次（每周一次或两次）低于传统HD（每周三次）。随着RRF下降，这种频次会增加（从每周一次增加到两次，从每周两次增加到三次）。
方法/设计：IHDIP是一项多中心随机实验性开放试验。它按1:1的比例随机分组，并通过常规临床实践进行对照，干预水平低且非商业性。该试验纳入152名年龄超过18岁的慢性肾脏病5期患者，他们开始将HD作为RRT，通过尿素肾清除率（KrU）测得的RRF≥4ml/min/1.73m²。干预组包括76名患者，他们将从每周一次HD开始（渐进性HD）。对照组包括76名患者，他们将从每周三次HD开始（传统HD）。主要目的是评估生存率，次要目的是发病率（住院情况）、临床参数、生活质量和效率。
本研究将使我们能够以最高水平的科学证据，了解患者开始HD治疗时应根据其RRF接受的治疗频次。
在美国国立卫生研究院的ClinicalTrials.gov上注册，注册号为NCT03239808。
