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NCT Number: NCT03352271

Individualized Incremental Hemodialysis Study

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.

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Key information

Conditions

Hemodialysis Complication Chronic Disease Disease Attributes ESRD Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Failure Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University, Mansourah, Alexandria Governorate, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Individualized Incremental hemodialysis

Procedure

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.

Conventional thrice weekly hemodialysis

Procedure

Thrice weekly hemodialysis program, the current standard of care for all patients, as a control

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Development of hypertrophic cardiomyopathy

    Time frame: 24 months

    Using Echocardiography to detect the development of hypertrophic cardiomyopathy

  4. Cost of care

    Time frame: 24 months

    comparing number of hemodialysis sessions in both groups multiplied by the cost of each session.

  5. 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

  6. Anemia Profile

    Time frame: 24 months

    Mean hemoglobin levels.

  7. Bone-mineral metabolism profile

    Time frame: 24 months

    Mean levels of calcium, phosphorus, parathyroid hormone PTH

  8. Vascular access complications

    Time frame: 24 months

    rate of infection, thrombosis and hematoma formation

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Collaborators

  • Fasila Hemodialysis Center
  • Kidney and urology Center
  • Mansoura University

Registry information

Official study title

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

Acronym: IIHD

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Nov 24, 2017
Registry last updated
Jan 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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