Individualized Incremental Hemodialysis Study
NCT03352271 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 122
Last updated 2021-01-13
Summary
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.
Conditions
- Hemodialysis Complication
- ESRD
- Renal Failure
Interventions
- PROCEDURE
-
Individualized Incremental hemodialysis
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.
- PROCEDURE
-
Conventional thrice weekly hemodialysis
Thrice weekly hemodialysis program, the current standard of care for all patients, as a control
Sponsors & Collaborators
-
Kidney and urology Center
collaborator UNKNOWN -
Mansoura University
collaborator OTHER -
Fasila Hemodialysis Center
collaborator UNKNOWN -
Alexandria University
lead OTHER
Principal Investigators
-
Mohamed E Elrggal, MD · Alexandria University
-
Mohamed A Sobh, MD · Mansoura University
-
Hussein A Sheashaa, MD · Mansoura University
-
Ahmed F Elkeraie, MD · Alexandria University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-06-01
- Primary Completion
- 2020-09-01
- Completion
- 2020-12-01
Countries
- Egypt
Study Locations
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