Individualized Incremental Hemodialysis Study

Study Overview
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Brief Summary
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Thrice weekly hemodialysis has been the standard of care all-over the world for end-stage renal disease (ESRD) requiring renal replacement therapy (RRT). Despite being in the era of precision medicine and individualized healthcare, this program doesn't take into account patients with residual kidney function (RKF) who don't require a thrice weekly hemodialysis frequency. Incremental hemodialysis (defined as twice weekly hemodialysis initiation in incident hemodialysis patients with residual kidney function) has been raised as an alternative to the conventional thrice weekly dialysis. Retrospective trials has proved safety of a twice weekly initiation with comparative efficacy to the thrice weekly program. Despite that, there is paucity of prospective observational and rarity of randomized controlled trials comparing both regimens. In this study, the investigators tend to provide a more individualized incremental hemodialysis approach to incident hemodialysis patients with residual urine volume and RKF. The investigators will compare the results to ESRD patients initiating a thrice weekly hemodialysis program.

Detailed Description
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This project aims to study the feasibility, safety and efficacy of individualized incremental (twice weekly, once weekly, once/10days or less frequent) hemodialysis (IIHD) initiation versus conventional thrice weekly HD for incident end stage renal disease (ESRD) patients with residual urine volume (RUV > 0.5 L/day, as a reference to residual kidney functions) who chose hemodialysis as their method of renal replacement therapy (RRT). Incremental HD has been an area of research interest in the past few years with many publications discussing its feasibility and safety for incident HD patients. Smooth transition to dialysis in incident ESRD patients through incremental twice (or even once) weekly dialysis initiation has shown benefits in preservation of residual kidney functions (RKF) in comparison to thrice weekly HD. It has also been proposed as a method of reducing healthcare cost while providing quality healthcare to the patients(1). However, most available data are retrospective analysis, few data are present to compare the results to thrice weekly HD in a randomized controlled or even in a prospective manner. Incremental HD has been also practiced in some parts of Egypt in the last 2-3 years. The investigators will compare outcomes of participants starting a less frequent dialysis program to conventional thrice weekly HD in a multi-center study.

Official Title
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Comparison of Clinical Outcomes Between Thrice-weekly and Individualized Incremental Hemodialysis in Incident Hemodialysis Patients

Conditions
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Hemodialysis Complication, ESRD, Renal Failure

Intervention / Treatment
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* Procedure: Individualized Incremental hemodialysis
* Procedure: Conventional thrice weekly hemodialysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with stage 5 chronic kidney disease (CKD) with estimated glomerular filtration rate of less than 10 ml/min/1.73m2 (using CKD-EPI equation for eGFR). Residual urine volume at least 0.5 L/day or more. Exclusion Criteria: Children < 18 years of age. Patients who were previously on other types of RRT, either on peritoneal dialysis, or on kidney transplant. Recent (within 3 months) acute kidney injury (AKI). Urine output less than 0.5 L/day. Active malignancy at time of inclusion. Active inflammatory disease with immunosuppressive treatment. Decompensated Liver disease, Hepatorenal syndrome. Cardiovascular disease defined as: heart failure type IV of the New York Heart Association (NYHA) or Cardiorenal syndrome.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individualized Incremental hemodialysis<br>ESRD patients starting an individualized (twice/week, once/week, once/10 days or less frequent) incremental hemodialysis program. | Procedure: Individualized Incremental hemodialysis<br>* Individualized Incremental hemodialysis program (twice/week, once/week, once/10days or less frequent) will be provided to incident ESRD patients according to their symptom presentation, clinical examination, investigations and daily urine volume measurement.<br>|
| Active Comparator: Thrice weekly dialysis<br>ESRD patients initiating a conventional thrice weekly hemodialysis program | Procedure: Conventional thrice weekly hemodialysis<br>* Thrice weekly hemodialysis program, the current standard of care for all patients, as a control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate after 24 months | To assess and compare Survival rate after 24 months in incident HD patients with individualized incremental HD (IIHD) as an RRT starting regimen, compared to those patients who start RRT with the conventional thrice weekly method. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause hospitalization rate | Rate of hospital admissions and number of days hospitalized for any cause (including cardiovascular events, CVE) during the 24 months. | 24 months | 
| Preservation of residual kidney function | Preservation of Residual kidney function (time to anuria defined as urine output UOP < 100 ml/day, rate of decline of RKF defined as the slope in decline of daily UOP measured monthly) during the 24 months of follow up. | 24 months | 
| Development of hypertrophic cardiomyopathy | Using Echocardiography to detect the development of hypertrophic cardiomyopathy | 24 months | 
| Cost of care | comparing number of hemodialysis sessions in both groups multiplied by the cost of each session. | 24 months | 
| Estimation of quality of life (QOL) | Comparing Quality of life survey values from Kidney Disease Quality of Life short form, KDQOL-SF v1.3, Arabic version between each group members | 24 months | 
| Anemia Profile | Mean hemoglobin levels. | 24 months | 
| Bone-mineral metabolism profile | Mean levels of calcium, phosphorus, parathyroid hormone PTH | 24 months | 
| Vascular access complications | rate of infection, thrombosis and hematoma formation | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Incremental hemodialysis, Precision medicine, Individualized care