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

Abstract

BackgroundMost 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/designIHDIP 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.DiscussionThis 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 registrationU.S. National Institutes of Health, ClinicalTrials.gov. Number: NCT03239808, completed 13/04/2017. Sponsor: Foundation for Training and Research of Health Professionals of Extremadura.Electronic supplementary materialThe online version of this article (10.1186/s12882-018-1189-6) contains supplementary material, which is available to authorized users.

A multicenter feasibility randomized controlled trial to assess the impact of incremental versus conventional initiation of hemodialysis on residual kidney function

“…A larger Spanish study plans to randomize 152 incident patients 1:1 to incremental or conventional HD with a primary outcome of survival. 29 An Italian study is also planned (N ¼ 116; Efficacy and Safety of Incremental Hemodialysis [NCT04360694]) randomizing patients to standard or incremental HD, which will also evaluate survival. Based on our findings, larger studies may be required to demonstrate survival or quality of life benefits.…”

Patiromer in a Patient with Severe Hyperkalemia on Incremental Hemodialysis with 1 Session per Week: A Case Report and Literature Review

“…However, in our center protocol, the Kur must be >4 mL/min measured in RKF, as a main criteria for the patient inclusion. This is based on the design proposed by Deira et al [ 7 ] in the IHDIP trial.…”

Evaluation of Residual Kidney Function during Once-Weekly Incremental Hemodialysis

“…The best time to determine RKF is rather bewilderingly still subject to debate. It should, however, be highlighted that urea does not unfortunately constitute the ideal molecule or with which to quantify depurative efficacy obtained in a single session or through the sum of Kt/V urea + residual kidney urea clearance [5, 44, 45]. Nevertheless, in current clinical practice, urea remains a valuable and rapid means of evaluating the dialysis efficiency of RKF in patients treated with 1WHD and is indispensable in assessing patient adherence to the hypoproteic regimen, thanks to the valid calculation of urea nitrogen appearance [46].…”