A prospective randomised controlled trial of incremental haemodialysis – INCH-HD. Trial protocol

Dr Martin Wolley1, Dr  Andrea Viecelli2,4, Donna Reidlinger4, Professor David Johnson2,4, Nicole Scholes-Robertson5, Professor Matthew Roberts3, Professor Carmel Hawley2,4

1Department of Renal Medicine, Royal Brisbane And Women’s Hospital, Brisbane, Australia, 2Department of Nephrology, Princess Alexandra Hospital, Brisbane, Australia, 3Eastern Health Clinical School, Monash University, Melbourne, Australia, 4Australasian Kidney Trials Network, Brisbane, Australia, 5Centre for Kidney Research, Children’s Hospital at Westmead, Westmead, Australia

Introduction:

Incident haemodialysis patients typically commence dialysis thrice weekly. Observational evidence suggests however that incremental haemodialysis (starting at <3/week and increasing as needed) is associated with at least equivalent mortality outcomes and may be associated with preservation of residual kidney function (RKF). Incremental HD has never been subject to a prospective randomised controlled trial (RCT) and robust safety data are needed before it can be advocated.

Methods:

The INCH-HD will be a multi-centre RCT randomising suitable patients to start conventional (3/week) or incremental (2/week) haemodialysis. Focus groups will decide on the primary outcome, with options including loss of RKF, health related quality of life and symptom scores. Secondary outcomes include safety and cost analysis. RKF and triggers to increase dialysis frequency are assessed monthly and other outcomes 3 monthly for a planned 18 month follow up period. A feasibility survey assessing clinician attitudes was performed in 2019.

Results:

If powered for loss of RKF 150 participants are needed (predicted HR 0.6 for incremental vs conventional). The ANZSN survey had 22 respondents of whom 57% already start patients on incremental HD and most expect patients to be on 2/week HD for 3-6 months prior to increasing. Most respondents (60%) were willing to randomise suitable patients to INCH-HD, suggesting feasibility to achieve enrolment targets.

Conclusion:

Incremental HD is an attractive concept which may offer benefits to RKF and quality of life outcomes as well as cost savings with acceptable safety. A prospective trial assuring safety is urgently needed and will be addressed with INCH-HD.


Biography:

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