End Stage Renal Disease on Dialysis Clinical Trial
Official title:
RandomizEd ClinicAL triaL on the Efficacy and saFety of Incremental Hemodialysis
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 and Transplantation of the Azienda Ospedaliero Universitaria Consorziale Policlinico, Bari, Italy and the EUDIAL Working Group of the European Renal Association - European Dialysis Transplant Association (ERA-EDTA) are starting a randomized clinical trial (RCT) in incident HD patients, whose name is "REAL LIFE", by using the acronym of its whole definition: RandomizEd clinicAL triaL on the effIcacy and saFety of incremental haEmodialysis. 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). The trial, originally conceived by experts at the Division of Nephrology of the Miulli General Hospital, Acquaviva delle Fonti, Italy, consists in starting the HD treatment adopting the new incremental approach guided by the VTM. The primary outcome is the survival of kidney function, with the event defined as urinary output (UO) ≤ 200 mL/day, confirmed by a further collection after 2 weeks to exclude temporary illness. Discussion: REAL LIFE will enable the investigators to know with the highest level of scientific evidence the safety and efficacy of an incremental approach to the start of HD treatment.
The majority of dialysis patients starting hemodialysis (HD) are currently treated with a fixed dose thrice-weekly 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) ≤ 200 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; patients survival; hospital admissions; anemia control; mineral and bone disorder control, and middle molecules removal. The sample size calculation is based on the primary outcome "presence of anuria". The assumptions for calculating the sample size, derived from data of Teruel Briones et al., are the following: - Percentage of subjects who developed anuria in the experimental group (incremental HD): 25% - Percentage of subjects who developed anuria in the control group (standard 3HD/wk): 51% - Power: 0.8 - Ratio: 1:1 - Non-compliance: 20% - Total expected sample size: 190 (95 participants in each group) 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 = 1.05), 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 1.05. PICO question: Participants with CKD-EPI GFR ≤ 10 ml/min and daily urine output > 600 ml Intervention: one or two weekly hemodialysis (as detailed above) Comparator: three weekly hemodialysis (as per standard practice and as detailed above) Outcome: Residual renal function ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05978479 -
The Effect of Individualized Education Using the Teach-Back Method Treatment on Treatment Adherence and the Coping Skills
|
N/A | |
Completed |
NCT06022835 -
Chlorhexidine Gluconate-gel Dressing for Exit Site Infection in Peritoneal Dialysis
|
N/A | |
Completed |
NCT05540457 -
Evaluation of Non-Invasive Continuous vs Intermittent BloodPressure Monitors in Maintenance Dialysis (BP Dialysis)
|
N/A | |
Recruiting |
NCT04046042 -
Virtual Reality Intradialysis: Last vs. First Part of the Session
|
N/A | |
Not yet recruiting |
NCT04527640 -
Effects of Synbiotics Supplementation on the Uremic Toxin Indoxyl Sulfate Level and Constipation in End-stage Renal Disease Patients Undergoing Hemodialysis
|
N/A | |
Completed |
NCT05947708 -
The Study of Intradialytic Symptoms in Subjects Treated With Qd 500vs Qd 300
|
N/A | |
Recruiting |
NCT05735743 -
MoVE Trial: Motivational Strategies to Empower African Americans to Improve Dialysis Adherence
|
N/A | |
Completed |
NCT04505462 -
Dietary Therapy in Dialysis Patients
|
N/A | |
Active, not recruiting |
NCT04546958 -
Nutritional Interventions in Peritoneal Dialysis Patients With Hypoalbuminemia
|
N/A | |
Recruiting |
NCT04286477 -
The Immune System in End Stage CKD Patients - Comparison Among Different Modalities of RRT
|
||
Completed |
NCT04487301 -
A Cross-Sectional Study to Assess Walking Performance in Subjects With Peripheral Artery and End Stage Kidney Disease
|
||
Recruiting |
NCT05677555 -
Colchicine and Inflammation in Hemodialysis Patients
|
Phase 2 | |
Completed |
NCT04789876 -
Effectiveness of The Phosphate Mobile App on Serum Phosphorus in Adult Hemodialysis Patients With Hyperphosphatemia
|
N/A | |
Completed |
NCT04125537 -
Pathways Project: Kidney Supportive Care
|
||
Suspended |
NCT05915286 -
Diuretic Use in Hemodialysis Patients With Residual Renal Function
|
Phase 4 | |
Completed |
NCT04912050 -
EXtension of Tablo TrEatmeNt Duration Registry
|
||
Recruiting |
NCT04501159 -
pH, Hypoxia and Haemodialysis
|
||
Recruiting |
NCT05032651 -
Use of a Novel Artificial Intelligence Assisted Platform to Assess Optimal Dosing and Treatment Strategy of Erythropoiesis-stimulating Agents (ESA) in Hemodialysis Patients
|
N/A | |
Completed |
NCT04806126 -
Evaluation of a Virtual Home Dialysis Mentoring Program (Home)
|
||
Recruiting |
NCT05671991 -
Effect of Empagliflozin on Peritoneal and Kidney Function in End Stage Renal Disease
|
Phase 4 |