Abstract
BackgroundThrice-weekly haemodialysis is the usual dose when starting renal replacement therapy; however, this schedule is no longer appropriate since it does not consider residual renal function. Several reports have suggested the potential benefit of beginning haemodialysis less frequently and incrementally increasing the dose as the residual renal function decreases. However, all the data published so far are from observational studies. Thus, this clinical trial avoids any potential selection bias and will assess the possible benefits that have been observed in observational studies.Methods/designThis report describes the study protocol of a randomized prospective multi-centre open-label clinical trial to evaluate whether starting renal replacement therapy with twice-weekly haemodialysis sessions preserves residual renal function better than the standard thrice-weekly regimen. We also explore other clinical parameters, such as concentrations of uremic toxins, dialysis doses, control of anaemia, removal of medium-weight uremic toxins, nutritional status, quality of life, hospital admissions and mortality. Only incident haemodialysis patients who can maintain a urea clearance rate KrU ≥ 2.5 mL/min/1.73 m2 are eligible. Patient recruitment began on 1 January 2017 and will last for 2 years or until the required sample size has been recruited to ensure the established statistical power has been reached. The minimum follow-up period will be 1 year. Anuric patients with acute renal failure and patients who return to haemodialysis after a kidney transplant failure are excluded. It has been calculated that 44 patients should be recruited into each group to achieve a power of 80% in a two-sided comparison of means with a usual significance level of 0.05. A time-to-event analysis will estimate the probability of kidney function survival in both groups using the Kaplan–Meier method. Survival curves will be compared with log-rank tests. This survival analysis will be complemented with a proportional hazard model to estimate the hazard ratio of kidney function survival adjusted for any confounding factors. Analyses will be carried out in accordance with the intention-to-treat principle.DiscussionThe incremental initiation of dialysis may preserve residual renal function better than the conventional treatment, with similar or higher survival rates, as reported by observational studies. To our knowledge, this is the first clinical trial to evaluate whether initiating renal replacement therapy with twice-weekly haemodialysis sessions preserves residual renal function better than beginning with the standard thrice-weekly regimen.Trial registrationClinicalTrials.gov, NCT03302546. Registered on 5 October 2017.
Highlights
Thrice-weekly haemodialysis is the usual dose when starting renal replacement therapy; this schedule is no longer appropriate since it does not consider residual renal function
The incremental initiation of dialysis may preserve residual renal function better than the conventional treatment, with similar or higher survival rates, as reported by observational studies. This is the first clinical trial to evaluate whether initiating renal replacement therapy with twice-weekly haemodialysis sessions preserves residual renal function better than beginning with the standard thrice-weekly regimen
In addition to differences in renal function at the start of haemodialysis, some centres exclude patients with certain comorbidities [11]. This clinical trial avoids selection bias and will assess the possible benefits that have been observed in observational studies
Summary
The transition from pre-dialysis to renal replacement therapy is a crucial moment for patients with chronic renal failure and has significant clinical, social and occupational impacts [27]. All previous studies have been observational, and prospective trials, such as this one, are required to determine, without selection bias, the potential benefits and safety of the incremental schedule [9,10,11, 28], and to establish the optimal group of patients who would benefit from this therapy. This randomized clinical trial compares twice- versus thrice-weekly haemodialysis sessions for patients who can maintain a residual urea clearance rate KrU ≥ 2.5 mL/min/1.73 m2, without excluding a priori patients with severe comorbidities. Abbreviations 2HD: Two haemodialysis sessions per week; 3HD: Three haemodialysis sessions per week; BNP: Brain-derived natriuretic peptide; CRP: C-reactive protein; KDOQI: Kidney Disease Outcomes Quality Initiative; KDQOLSF: Kidney Disease Quality of Life Short Form; KrCr: Creatinine clearance rate; KrU: Urea clearance rate; PTH: Parathyroid hormone
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