Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05418647

Effect of Low Versus High Dialysate Sodium Concentration During Hemodialysis on Dialysis Recovery Time: A Prospective Randomized Clinical Trial

Led by Alexandria University · Updated on 2025-02-11

40

Participants Needed

2

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research evaluates the impact of different sodium levels in dialysate on the time it takes patients to recover after hemodialysis. It focuses on patients with chronic kidney disease undergoing long-term hemodialysis, a group known to suffer frequent fatigue that affects their quality of life. The study addresses the common issue of post-hemodialysis fatigue, which is often underestimated by healthcare providers, aiming to better understand factors influencing recovery time. Participants will receive either high sodium dialysate (141 mmol/L) or low sodium dialysate (136 mmol/L) during their hemodialysis treatments. Each treatment period lasts 8 weeks. The study is designed as a randomized trial comparing these two sodium concentration settings to observe their effects on recovery time and other health measures. During the study, participants will be assessed at baseline, week 4, and week 8 for changes in dialysis recovery time, plasma sodium levels, weight gain between dialysis sessions, blood pressure, and the occurrence of symptoms such as low blood pressure during dialysis, muscle cramps, and headaches. These evaluations help researchers monitor patient responses and safety over the 8-week treatment periods.

CONDITIONS

Brief Title

Effect of Low Versus High Dialysate Sodium Concentration During Hemodialysis on Dialysis Recovery Time

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with end-stage renal disease prescribed long-term hemodialysis undergoing four-hour sessions three times a week for more than 90 days
  • Patients at least 18 years old
  • Able to read and write
  • In complete mental health
Not Eligible

You will not qualify if you...

  • Inability to complete surveys due to reading or hearing difficulties
  • Clinical instability requiring hospitalization
  • Dementia
  • Active malignancy
  • Liver failure

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 8 weeks

Participants receive either high or low dialysate sodium concentration during hemodialysis sessions.

Three hemodialysis sessions per week for 8 weeks

Trial Site Locations

Total: 2 locations

1

Faculty of Medicine, Aexandria University

Alexandria, Egypt, 21526

Not Yet Recruiting

2

Faculty of Medicine, Alexandria University

Alexandria, Egypt

Actively Recruiting

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Research Team

M

Mohamed Mamdouh Elsayed, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Minutes to recovery after a hemodialysis session: a simple health-related quality of life question that is reliable, valid, and sensitive to change.

Robert M Lindsay, Paul A Heidenheim, Gihad Nesrallah...

https://pubmed.ncbi.nlm.nih.gov/17699312

Recovery time, quality of life, and mortality in hemodialysis patients: the Dialysis Outcomes and Practice Patterns Study (DOPPS).

Hugh C Rayner, Lindsay Zepel, Douglas S Fuller...

https://pubmed.ncbi.nlm.nih.gov/24529994