Rationale and design of DiPPI: A randomized controlled trial to evaluate the safety and effectiveness of progressive hemodialysis in incident patients

• Published in: Nefrología 2018-11, Vol.38 (6), p.630-638
• Main Authors: 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
• Format: Article
• Language: English
• ISSN: 2013-2514
• DOI: 10.1016/j.nefroe.2018.11.011

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 randomized 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 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. Resumen: 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 ≥4 ml/min/1,73 m2. El estudio se basa en un grupo de interve