Individualized Incremental Hemodialysis Study

NCT03352271 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2021-01-13

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03352271 on ClinicalTrials.gov