Individualized Incremental Hemodialysis Study

Not Applicable

Completed

• Conditions: Hemodialysis Complication; ESRD; Renal Failure
• Interventions: Procedure: Individualized Incremental hemodialysis; Procedure: Conventional thrice weekly hemodialysis

• Registration Number: NCT03352271
• Lead Sponsor: Alexandria University

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.

Study Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2017-11-16
• Study First Submitted QC: 2017-11-21
• Study First Posted: 2017-11-24
• Primary Completion: 2020-09-01
• Study Completion: 2020-12-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-12
• Last Update Posted: 2021-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individualized Incremental hemodialysis	Individualized Incremental hemodialysis	ESRD patients starting an individualized (twice/week, once/week, once/10 days or less frequent) incremental hemodialysis program.
Thrice weekly dialysis	Conventional thrice weekly hemodialysis	ESRD patients initiating a conventional thrice weekly hemodialysis program

Primary Outcome Measures

Name	Time	Method
Survival rate after 24 months	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.

Secondary Outcome Measures

Name	Time	Method
All-cause hospitalization rate	24 months	Rate of hospital admissions and number of days hospitalized for any cause (including cardiovascular events, CVE) during the 24 months.
Estimation of quality of life (QOL)	24 months	Comparing Quality of life survey values from Kidney Disease Quality of Life short form, KDQOL-SF v1.3, Arabic version between each group members
Vascular access complications	24 months	rate of infection, thrombosis and hematoma formation
Cost of care	24 months	comparing number of hemodialysis sessions in both groups multiplied by the cost of each session.
Anemia Profile	24 months	Mean hemoglobin levels.
Bone-mineral metabolism profile	24 months	Mean levels of calcium, phosphorus, parathyroid hormone PTH
Preservation of residual kidney function	24 months	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.
Development of hypertrophic cardiomyopathy	24 months	Using Echocardiography to detect the development of hypertrophic cardiomyopathy

Trial Locations

Locations (2)

kidney and Urology Center; 🇪🇬 Alexandria, Egypt

Mansoura University; 🇪🇬 Mansourah, Alexandria, Egypt