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Short, frequent, 5-days-per-week, in-center hemodialysis versus 3-days-per week treatment: a randomized crossover pilot trial through the Midwest Pediatric Nephrology Consortium

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Abstract

Background

No controlled trials in children with end-stage kidney disease have assessed the benefits of more frequently administered hemodialysis (HD).

Methods

We conducted a multicenter, crossover pilot trial to determine if short, more frequent (5 days per week) in-center HD was feasible and associated with improvements in blood pressure compared with three conventional HD treatments per week. Because adult studies have not controlled for the weekly duration of dialysis, we fixed the total treatment time at 12 h a week of dialysis during two 3-month study periods; only frequency varied from 5 to 3 days per week between study periods.

Results

Eight children (median age 16.7 years) consented at three children’s hospitals. The prespecified primary composite outcome was a sustained 10% decrease in systolic blood pressure and/or a decrease in antihypertensive medications relative to each study period’s baseline. Among the six patients completing both study periods, five (83.3%) experienced the primary outcome during HD performed 5 days per week but not 3 days per week; one of the six (16.7%) achieved that outcome during 3-day but not 5-day (p = 0.22) per week HD. During 5-day HD, all patients had significantly more treatments during which their pre-HD systolic (p = 0.01) or diastolic (p = 0.01) blood pressure was 10% lower than baseline.

Conclusions

We observed that more frequent HD sessions per week was feasible and associated with improved blood pressure control, but barriers to changing thrice-weekly standard of care include financial reimbursement and the time demands associated with more frequent treatments.

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Acknowledgements

Dr. Laskin and this research were supported by National Institutes of Health (NIH) grants 1KM1CA156715-01 and K23DK101600. Dr. Mitsnefes and this research were supported by K24DK090070. The REDCap database was created with assistance from the University of Cincinnati Center for Clinical and Translational Science and Training (CCTST). Funding for the CTRC comes in part from USPHS Grant #UL1 RR026314 from the National Center for Research Resources, NIH. Funding for CCTST come from an Institutional Clinical and Translational Science Award, NIH/NCRR Grant Number 5UL1RR026314-02. At CHOP, the project described was supported by the National Center for Research Resources, Grant UL1RR024134, and is now at the National Center for Advancing Translational Sciences, Grant UL1TR000003. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. The Quality of Life study described in this paper was carried out using the PedsQLTM, developed by Dr. James W. Varni. Fresenius Medical Care North America provided funds to help cover research costs for the patients treated at CCHMC. None of these funders had any role in study design, collection, analysis, or interpretation of data, writing the report, or the decision to submit the report for publication. We thank Victoria Moore for her assistance with the echocardiogram data and the dialysis nurses, study coordinators, and patients/families at the participating centers.

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Correspondence to Benjamin L. Laskin.

Ethics declarations

Written consent was obtained from all participants or their parents/guardians and all participants also provided assent. The study was approved by the separate Institutional Review Boards at the three centers and was registered on ClinicalTrials.gov (NCT01352455).

Financial Disclosure

Dr. Laskin has served as a site principal investigator for industry-sponsored studies by Amgen, Genzyme, and Vifor Pharma.

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Laskin, B.L., Huang, G., King, E. et al. Short, frequent, 5-days-per-week, in-center hemodialysis versus 3-days-per week treatment: a randomized crossover pilot trial through the Midwest Pediatric Nephrology Consortium. Pediatr Nephrol 32, 1423–1432 (2017). https://doi.org/10.1007/s00467-017-3656-x

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