IHDIP: a controlled randomized trial to assess the security and effectiveness of the incremental hemodialysis in incident patients

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...

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Detalles Bibliográficos
Autores: Deira, J., Suárez, M. A., López, F., García-Cabrera, E., Gascón, A., Torregrosa, E., García Rodríguez, Giannina Elena, Huertas, J., de la Flor, J. C., PUELLO MARTINEZ, SULEYKA, Gómez-Raja, J., Grande, J., Lerma, J. L., Corradino, C., Musso, C., Martín, J., Basile, C., Casino, F.G.
Tipo de recurso: artículo
Fecha de publicación:2019
País:España
Institución:Servizo Galego de Saúde (SERGAS)
Repositorio:RUNA. Repositorio da Consellería de Sanidade e Sergas
OAI Identifier:oai:runa.sergas.gal:20.500.11940/15417
Acceso en línea:https://www.ncbi.nlm.nih.gov/pubmed/30626347
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6325813/pdf/12882_2018_Article_1189.pdf
http://hdl.handle.net/20.500.11940/15417
Access Level:acceso abierto
Palabra clave:Kidney
Humans
Creatinine
Multicenter Studies as Topic
Prospective Studies
Urea
Renal Dialysis
Randomized Controlled Trials as Topic
diálisis renal
estudios prospectivos
riñón
estudios multicéntricos como asunto
humanos
ensayos clínicos controlados aleatorizados como asunto
urea
creatinina
CHUF
CHUS
Descripción
Sumario: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.