Initiating renal replacement therapy through incremental haemodialysis: Protocol for a randomized multicentre...

Area of Science:

• Nephrology
• Clinical Trials
• Renal Replacement Therapy

Background:

• Standard renal replacement therapy initiation involves thrice-weekly haemodialysis, which may not account for residual renal function.
• Observational studies suggest that initiating haemodialysis less frequently could benefit residual renal function.
• This trial addresses the need for robust evidence by avoiding selection bias inherent in observational studies.

Purpose of the Study:

• To evaluate if initiating renal replacement therapy with twice-weekly haemodialysis preserves residual renal function more effectively than a thrice-weekly schedule.
• To explore the impact of different haemodialysis initiation frequencies on uremic toxin levels, dialysis dose, anemia control, and quality of life.

Main Methods:

• A prospective, multi-centre, open-label, randomized clinical trial.
• Inclusion criteria: incident haemodialysis patients with urea clearance rate KrU ≥ 2.5 mL/min/1.73 m².
• Exclusion criteria: anuric patients, acute renal failure, or return to haemodialysis after transplant failure.
• Sample size: 44 patients per group, with a minimum follow-up of 1 year.
• Statistical analysis: intention-to-treat principle, Kaplan-Meier method, log-rank tests, and proportional hazard models.

Main Results:

• The study protocol is described, detailing the methodology for comparing twice-weekly versus thrice-weekly haemodialysis initiation.
• The primary outcome is the preservation of residual renal function.
• Secondary outcomes include uremic toxin levels, dialysis adequacy, nutritional status, quality of life, hospital admissions, and mortality.

Conclusions:

• Observational data suggest incremental dialysis initiation may preserve residual renal function and offer similar or better survival rates.
• This is the first randomized clinical trial designed to rigorously assess the benefits of initiating haemodialysis twice weekly versus thrice weekly.