RandomizEd ClinicAL triaL on the Efficacy and saFety of Incremental Hemodialysis (REAL-LIFE)

Launched by AZIENDA OSPEDALIERO-UNIVERSITARIA CONSORZIALE POLICLINICO DI BARI · Apr 21, 2020

Keywords

ClinConnect Summary

The REAL LIFE trial is studying a new approach to hemodialysis (HD) for patients with end-stage renal disease, which is when the kidneys no longer work well enough to keep you healthy. This trial compares the traditional method of receiving dialysis three times a week to a new method called incremental dialysis, which may allow for fewer treatments based on how well the kidneys are still functioning. The goal is to see if this new approach is just as safe and effective, particularly in preserving kidney function for longer.

To be eligible to participate, you must be an adult over 18 years old who has just started or is about to start maintenance hemodialysis because of advanced kidney disease. You should have very low kidney function, specifically a measure called glomerular filtration rate (GFR) of 10 or less. Participants can expect to be randomly assigned to either the traditional or the incremental treatment group and will help researchers understand the best way to manage dialysis for people in similar situations. This trial is important because it aims to provide clear answers about the safety and effectiveness of using this new incremental method.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adults aged \> 18 years
• • Start of maintenance hemodialysis treatment due to advanced CKD stage 5D
• • Patients who are about to start HD or have already started HD within a period of ≤ 2 weeks
• • Glomerular filtration rate \<= 10 mL/min/1.73 m2, as estimated by means of CKD-EPI formula.
• Exclusion Criteria:
• • Age \< 18 years
• • Acute kidney injury or acute on chronic kidney injury
• • eGFR higher than 10 mL/min/1.73 m2
• • UO \< 600 mL/day
• • Already treated with other replacement therapies (peritoneal dialysis or kidney transplant)
• • Unable or unwilling to give informed consent.
• • Unable to comply with trial procedures, e.g., collection of UO.
• • Likely survival prognosis or planned modality or centre transfer \< 6 months.
• • Patients who are in the waiting list for a living kidney transplant
• • Associated diseases: active neoplastic disease; refractory congestive heart failure (type IV NYHA, ejection fraction ≤ 30%) requiring high ultrafiltration volumes per session.