Abstract
Introduction
The optimal haemodialysis (HD) prescription—frequency and dose—for
patients with incident dialysis-dependent kidney disease (DDKD) and
substantial residual kidney function (RKF)—that is, renal urea clearance
≥2 mL/min/1.73 m2 and urine volume ≥500 mL/day—is
not known. The aim of the present study is to test the feasibility and
safety of a simple, reliable prescription of incremental HD in patients
with incident DDKD and RKF.
Methods and analysis
This parallel-group, open-label randomised pilot trial will enrol 50
patients from 14 outpatient dialysis units. Participants will be
randomised (1:1) to receive twice-weekly HD with adjuvant
pharmacological therapy for 6 weeks followed by thrice-weekly HD
(incremental HD group) or outright thrice-weekly HD (standard HD group).
Age ≥18 years, chronic kidney disease progressing to DDKD and urine
output ≥500 mL/day are key inclusion criteria; patients with left
ventricular ejection fraction <30% and acute kidney injury requiring
dialysis will be excluded. Adjuvant pharmacological therapy (ie,
effective diuretic regimen, patiromer and sodium bicarbonate) will
complement twice-weekly HD. The primary feasibility end points are
recruitment rate, adherence to the assigned HD regimen, adherence to
serial timed urine collections and treatment contamination. Incidence
rate of clinically significant volume overload and metabolic imbalances
in the first 3 months after randomisation will be used to assess
intervention safety.
Ethics and dissemination
The study has been reviewed and approved by the Institutional Review
Board of Wake Forest School of Medicine in North Carolina, USA. Patient
recruitment began on 14 June 2019, was paused between 13 March 2020 and
31 May 2020 due to COVID-19 pandemic, resumed on 01 June 2020 and will
last until the required sample size has been attained. Participants will
be followed in usual care fashion for a minimum of 6 months from last
individual enrolled. All regulations and measures of ethics and
confidentiality are handled in accordance with the Declaration of
Helsinki.
Trial registration number
NCT03740048; Pre-results.
Cited by
11 articles.
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