Individualized Incremental Hemodialysis Study (IIHD)

January 12, 2021 updated by: Mohamed Elrggal, Alexandria University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Kidney and Urology Center
    • Alexandria
      • Mansourah, Alexandria, Egypt, 21529
        • Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Individualized Incremental hemodialysis
ESRD patients starting an individualized (twice/week, once/week, once/10 days or less frequent) incremental hemodialysis program.
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.
Active Comparator: Thrice weekly dialysis
ESRD patients initiating a conventional thrice weekly hemodialysis program
Procedure: Conventional thrice weekly hemodialysis
Thrice weekly hemodialysis program, the current standard of care for all patients, as a control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival rate after 24 months
Time Frame: 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
Time Frame: 24 months
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
Time Frame: 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.
24 months
Development of hypertrophic cardiomyopathy
Time Frame: 24 months
Using Echocardiography to detect the development of hypertrophic cardiomyopathy
24 months
Cost of care
Time Frame: 24 months
comparing number of hemodialysis sessions in both groups multiplied by the cost of each session.
24 months
Estimation of quality of life (QOL)
Time Frame: 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
24 months
Anemia Profile
Time Frame: 24 months
Mean hemoglobin levels.
24 months
Bone-mineral metabolism profile
Time Frame: 24 months
Mean levels of calcium, phosphorus, parathyroid hormone PTH
24 months
Vascular access complications
Time Frame: 24 months
rate of infection, thrombosis and hematoma formation
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Collaborators

Mansoura University
Kidney and urology Center
Fasila Hemodialysis Center

Investigators

  • Principal Investigator: Mohamed E Elrggal, MD, Alexandria University
  • Study Chair: Mohamed A Sobh, MD, Mansoura University
  • Study Chair: Hussein A Sheashaa, MD, Mansoura University
  • Study Chair: Ahmed F Elkeraie, MD, Alexandria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

September 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

November 16, 2017

First Submitted That Met QC Criteria

November 21, 2017

First Posted (Actual)

November 24, 2017

Study Record Updates

Last Update Posted (Actual)

January 13, 2021

Last Update Submitted That Met QC Criteria

January 12, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MER17MD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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