Efficacy and Safety of Incremental Hemodialysis
Słowa kluczowe
Abstrakcyjny
Opis
The majority of dialysis patients are currently treated with a fixed dose thrice-weekly haemodialysis (HD) (3HD/wk). The 3HD/wk regimen has been assumed, until recently, almost as a dogma in the dialysis community. Incremental HD is based on the simple idea of adjusting its dose according to the metrics of RKF. REAL LIFE is a pragmatic, prospective, multicentre, open label RCT, investigator-initiated, comparing the intervention arm (incremental HD) with the control arm (standard 3HD/wk). A Variable Target Model (VTM) has been suggested, which gives more clinical weight to the RKF and allows less frequent HD treatments in patients with lower RKF. The investigators recommend to start and keep on with once-weekly HD, which should be possible until residual renal urea clearance (KRU) falls below 2.5 - 3.0 mL/min/35 L, i.e., glomerular filtration rate (GFR) ≈ 4 mL/min/1.73 m2. The primary outcome is the survival of kidney function, with the event defined as urinary output (UO) ≤ 100 mL/day, confirmed by a further collection after 2 weeks to exclude temporary illness. Secondary outcomes are: composite primary cardiovascular endpoint (cardiovascular death, non fatal myocardial infarction and/or or non fatal stroke); intima-media thickness of the carotid arteries; specific cardiomyopathy control; RKF preservation; survival of the patients; hospital admissions; anemia control; mineral and bone disorder control; middle molecules and RKF. Considering a type I error of 0.05 and type II error of 0.20, the study must enroll 49 patients in the conventional HD arm and 49 patients in the incremental HD arm, totaling 98 patients enrolled into the trial. Finally, under the assumption of an expected drop-out rate of 15%, 58 patients per group should be enrolled for a total of 116. The assessment of the key kinetic parameters as well as the guide to the selection of operative parameters, as required to get the required equilibrated Kt/V (eKt/V = 1.2), will be done by using SPEEDY, a spreadsheet prescription tool that uses essentially the same equations used by Solute Solver, the software based on the double pool UKM recommended by the 2015 KDOQI guidelines. SPEEDY is freely available at the European Nephrology Portal (ENP). The link is https://enp-era-edta.org/174/page/home. The control arm includes patients put on a thrice-weekly HD schedule, as detailed above. The dialysis dose (eKt/V) should be about 1.2.
Daktyle
Ostatnia weryfikacja: | 03/31/2020 |
Pierwsze przesłane: | 04/16/2020 |
Szacowana liczba przesłanych rejestracji: | 04/20/2020 |
Wysłany pierwszy: | 04/23/2020 |
Ostatnia aktualizacja przesłana: | 04/20/2020 |
Ostatnia opublikowana aktualizacja: | 04/23/2020 |
Rzeczywista data rozpoczęcia badania: | 08/31/2020 |
Szacowana data zakończenia podstawowej działalności: | 11/30/2023 |
Szacowana data zakończenia badania: | 11/30/2024 |
Stan lub choroba
Interwencja / leczenie
Procedure: Incremental hemodialysis
Procedure: Conventional hemodialysis
Faza
Grupy ramion
Ramię | Interwencja / leczenie |
---|---|
Experimental: Incremental hemodialysis Procedure: Incremental hemodialysis. It consists in reducing the frequency or number of sessions per week with which patients start the HD treatment. The experimental group will start with one session/week, then the number of weekly sessions will be increased to two and later to three as per criteria for progression | Procedure: Incremental hemodialysis 58 patients will start renal replacement therapy (RRT) with an incremental hemodialysis (once-weekly or twice-weekly) regimen. |
Active Comparator: Conventional hemodialysis Procedure: Conventional hemodialysis. It is controlled through usual clinical practice, based on starting the HD treatment with three sessions per week (control group). | Procedure: Conventional hemodialysis 58 patients will start renal replacement therapy (RRT) with the standard (thrice-weekly) hemodialysis regimen. |
Kryteria kwalifikacji
Wiek kwalifikujący się do nauki | 18 Years Do 18 Years |
Płeć kwalifikująca się do nauki | All |
Przyjmuje zdrowych wolontariuszy | tak |
Kryteria | Inclusion Criteria: - Adults aged > 18 years - Start of maintenance hemodialysis treatment due to advanced CKD stage 5D - Glomerular filtration rate (GFR) ranging from 4 to 10 mL/min/1.73 m2, as estimated by means of CKD-EPI formula or as a mean of the measured urea and creatinine clearances. Exclusion Criteria: - Age < 18 years - Acute kidney injury or acute on chronic kidney injury - Tranferred from other dialysis modalities (peritoneal dialysis) or restarting HD after kidney transplant rejection - eGFR lesser than 4 mL/min/1.73 m2 or greater than 10 mL/min/1.73 m2 - UO < 500 mL/day - 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. - Associated diseases: active neoplastic disease; refractory congestive heart failure (type IV NYHA) requiring high ultrafiltration volumes per session. |
Wynik
Podstawowe miary wyników
1. Survival of kidney function [24 months]
Miary wyników wtórnych
1. Composite primary cardiovascular endpoint [24 months]
2. Intima-media thickness of the carotid arteries [24 months]
3. Specific cardiomyopathy control [24 months]
4. Residual kidney function (RKF) preservation [24 months]
5. Survival of the patients [24 months]
6. Hospital admissions [24 months]
7. Anemia control [24 months]
8. Mineral and bone disorder control [24 months]
9. Middle molecules and RKF [24 months]