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Technical requirements and devices available for long-term hemodialysis in children—mind the gap!

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Abstract

Children requiring long-term kidney replacement therapy are a “rare disease” cohort. While the basic technical requirements for hemodialysis (HD) are similar in children and adults, key aspects of the child’s cardiovascular anatomy and hemodynamic specifications must be considered. In this article, we describe the technical requirements for long-term HD therapy for children and the devices that are currently available around the world. We highlight the characteristics and major technical shortcomings of permanent central venous catheters, dialyzers, dialysis machines, and software available to clinicians who care for children. We show that currently available HD machines are not equipped with appropriately small circuits and sensitive control mechanisms to perform safe and effective HD in the youngest patients. Manufacturers limit their liability, and health regulatory agencies permit the use of devices, only in children according to the manufacturers’ pre-specified weight limitations. Although registries show that 6–23% of children starting long-term HD weigh less than 15 kg, currently, there is only one long-term HD device that is cleared for use in children weighing 10 to 15 kg and none is available and labelled for use in children weighing less than 10 kg anywhere in the world. Thus, many children are being treated “off-label” and are subject to interventions delivered by medical devices that lack pediatric safety and efficacy data. Moreover, recent improvements in dialysis technology offered to adult patients are denied to most children. We, in turn, advocate for concerted action by pediatric nephrologists, industry, and health regulatory agencies to increase the development of dedicated HD machines and equipment for children.

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Acknowledgements

We would like to thank the nurses on our teams for their knowledge of dialysis machines and their commitment to children’s care, the patients and their families for their trust, and the manufacturers’ representatives for their support in gathering information about the devices. We also gratefully acknowledge the following colleagues for help with data extraction: Marjolein Bonthuis for the ESPN/ERA registry, Kimberly Nieman for the USRDS registry, and Dagmara Borzych-Duzalka for the IPHN registry.

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Authors and Affiliations

  1. Pediatric Nephrology Unit, Hôpital Femme Mère Enfant, Hospices Civils de Lyon, Université de Lyon, Lyon, France

    Bruno Ranchin & Melodie Mosca

  2. Centre de référence des maladies rénales rares, Hôpital Femme Mère Enfant, Hospices Civils de Lyon, 59 boulevard Pinel, 69677, Bron Cedex, France

    Bruno Ranchin

  3. Pediatric Nephrology, Center for Pediatrics and Adolescent Medicine, University of Heidelberg, Heidelberg, Germany

    Claus Peter Schmitt

  4. Division of Nephrology, Department of Pediatrics, Children’s Mercy Kansas City, Kansas City, MO, USA

    Bradley A. Warady

  5. Department of Nephrology, Tokyo Metropolitan Children’s Medical Center, Fuchu, Japan

    Hiroshi Hataya

  6. Department of Pediatrics, School of Medicine, Keio University, Shinjuku-ku, Tokyo, Japan

    Hiroshi Hataya

  7. Queensland Children’s Hospital, University of Queensland, Brisbane, Australia

    Joanne Jones

  8. Centre for Kidney Disease Research, University of Queensland, Brisbane, Australia

    Rowena Lalji

  9. Department of Nephrology, Queensland Children’s Hospital, Brisbane, Australia

    Rowena Lalji

  10. Metro South and Integrated Nephrology and Transplant Services, Princess Alexandra Hospital, Brisbane, Australia

    Rowena Lalji

  11. Department of Pediatrics, University of Toronto, Toronto, ON, Canada

    Christoph Licht

  12. Division of Nephrology and Research Institute, Cell Biology Program, The Hospital for Sick Children, Toronto, ON, Canada

    Christoph Licht

  13. University College London Great Ormond Street Hospital and Institute of Child Health, London, UK

    Lynsey Stronach & Rukshana Shroff

  14. Pediatric Nephrology Unit, Department for Woman and Child’s Health, University-Hospital of Padua, Padua, Italy

    Enrico Vidal

  15. Department of Pediatric Nephrology, Ghent University Hospital, Ghent, Belgium

    Johan Vande Walle

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  1. Bruno Ranchin
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Correspondence to Bruno Ranchin.

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Conflict of interest

RS has received research grants from Fresenius Medical Care, speaker honoraria from Fresenius Medical Care and Amgen, and consulting fees from AstraZeneca and Humacyte. CPS has received consulting fees from Baxter, Iperboreal, and Stadapharma; speaker honoraria from Fresenius Medical Care; and research grants from Baxter and Invizius. The other authors do not declare any conflict of interest.

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Ranchin, B., Schmitt, C.P., Warady, B.A. et al. Technical requirements and devices available for long-term hemodialysis in children—mind the gap!. Pediatr Nephrol (2023). https://doi.org/10.1007/s00467-023-06233-0

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