Clinical trial NCT03352271: Individualized Incremental Hemodialysis Study
Official title: Comparison of Clinical Outcomes Between Thrice-weekly and Individualized Incremental Hemodialysis in Incident Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis Complication
ESRD
Renal Failure
Keywords: Incremental hemodialysis
Precision medicine
Individualized care
Lead sponsor: Alexandria University
Sponsor class: OTHER
Collaborators: name: Kidney and urology Center
name: Mansoura University
name: Fasila Hemodialysis Center
First posted: 2017-11-24
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. 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).
2. Residual urine volume at least 0.5 L/day or more.

Exclusion Criteria:

1. Children \< 18 years of age.
2. Patients who were previously on other types of RRT, either on peritoneal dialysis, or on kidney transplant.
3. Recent (within 3 months) acute kidney injury (AKI).
4. Urine output less than 0.5 L/day.
5. Active malignancy at time of inclusion.
6. Active inflammatory disease with immunosuppressive treatment.
7. Decompensated Liver disease, Hepatorenal syndrome.
8. Cardiovascular disease defined as: heart failure type IV of the New York Heart Association (NYHA) or Cardiorenal syndrome.

Primary outcomes:
measure: Survival rate after 24 months
timeFrame: 24 months
Secondary outcomes:
measure: All-cause hospitalization rate
timeFrame: 24 months
measure: Preservation of residual kidney function
timeFrame: 24 months
measure: Development of hypertrophic cardiomyopathy
timeFrame: 24 months
measure: Cost of care
timeFrame: 24 months
measure: Estimation of quality of life (QOL)
timeFrame: 24 months
measure: Anemia Profile
timeFrame: 24 months
measure: Bone-mineral metabolism profile
timeFrame: 24 months
measure: Vascular access complications
timeFrame: 24 months
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura University
state: Alexandria
city: Alexandria
country: Egypt
facility: kidney and Urology Center
Study officials:
affiliation: Alexandria University
name: Mohamed E Elrggal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mansoura University
name: Mohamed A Sobh, MD
role: STUDY_CHAIR
affiliation: Mansoura University
name: Hussein A Sheashaa, MD
role: STUDY_CHAIR
affiliation: Alexandria University
name: Ahmed F Elkeraie, MD
role: STUDY_CHAIR
References:
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