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

RecruitingNAAges 18 Years - anyAllAzienda Ospedaliero-Universitaria Consorziale Pol…
NCT04360694 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Background: The thrice-weekly hemodialysis (HD) regimen is widely accepted as a standard prescription. The concept of incremental dialysis has been established as a possible alternative for patients with preserved diuresis and end-stage renal failure in need of HD. The main problems related to prescription of incremental HD are an arbitrary use of infrequent regimens and the lack of clear standards for incorporating residual kidney function (RKF) in the assessment of HD dose. Several models have been proposed for prescription of incremental dialysis. The latest, the variable target model (VTM), gives more clinical weight to the RKF and allows less frequent HD treatments at lower RKF. Despite increasing evidence derived from observational studies to support the use of incremental HD, RCTs are lacking and, therefore, urgently needed. Methods/Design: The Department of Nephrology, Dialysis

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📋 Eligibility rules (as published)
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.
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What it tests

  • Incremental hemodialysis
  • Conventional hemodialysis
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Where

1 site
Azienda Ospedaliero Universitaria Consorziale Policlinico
Bari, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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