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

Javier Deira, Miguel A Suárez, Francisca López, Emilio García-Cabrera, Antonio Gascón, Eduardo Torregrosa, Giannina E García, Jorge Huertas, Jose C de la Flor, Suleya Puello, Jonathan Gómez-Raja, Jesús Grande, José L Lerma, Carlos Corradino, Carlos Musso, Manuel Ramos, Jesús Martín, Carlo Basile, Francesco G Casino, Javier Deira, Miguel A Suárez, Francisca López, Emilio García-Cabrera, Antonio Gascón, Eduardo Torregrosa, Giannina E García, Jorge Huertas, Jose C de la Flor, Suleya Puello, Jonathan Gómez-Raja, Jesús Grande, José L Lerma, Carlos Corradino, Carlos Musso, Manuel Ramos, Jesús Martín, Carlo Basile, Francesco G Casino

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.

Keywords: Incremental haemodialysis progressive hemodialysis; Once-weekly haemodialysis; Randomized clinical trial; Twice-weekly haemodialysis.

Conflict of interest statement

Ethics approval and consent to participate

The study was evaluated and approved (March 28, 2017) by the institutional review board (IRB) of the San Pedro de Alcántara Hospital in Cáceres, Spain. According to the national regulation of clinical trials, the main IRB enables other centers in Spain to carry out the study, providing umbrella coverage for the Spanish centers. However other IRB have evaluated the protocol, the full names of all IRBs which approved the study protocol are listed in an Additional file 4. All participants in the study will be informed about their potential participation and asked to sign the informed consent, if agree to participate. The trial was endorsed by the Spanish Society of Nephrology.

Consent for publication

“Not Applicable”.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Schema for IHDIP Trial

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Source: PubMed

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