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

A

Alexandria University

Status

Enrolling

Conditions

Dialysis; Complications

Treatments

Other: high dialysate Na
Other: low dialysate Na

Study type

Interventional

Funder types

Other

Identifiers

NCT05418647
dialysate Na and DRT

Details and patient eligibility

About

This research aims to assess the effect of low versus high dialysate sodium concentration during hemodialysis on dialysis recovery time

Full description

Chronic kidney disease (CKD) is a general term for heterogeneous disorders affecting the structure and function of the kidney. The variation in disease expression is partly related to the cause, pathology, severity and the rate of progression. Fatigue is a well-known and frequent symptom in HD patients with a reported association with the decrease in health-related quality of life commonly found in this population. The prevalence of fatigue ranges from 60% to as high as 97% in patients on long-term renal replacement therapy. Despite this fact, health care providers are still unaware of both its presence and severity. Several methods have been proposed as a way to assess post-HD fatigue with the "time to recover (minutes) from HD" being one of them. Lindsay et al.assisted patients' responses to the single open-ended question, "How long does it take you to recover from a dialysis session?". Although post-HD fatigue commonly exists in dialysis patients, it is usually underestimated by physicians. For this reason, appropriate and early identification of symptoms and associated factors might improve the patient's quality of life. Rayner et al. found that dialysate Na was inversely associated with DRT where lowering the Na concentration in the dialysate (to 140 mEq/L) was linked to a longer DRT.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with end-stage renal disease who have been prescribed long term hemodialysis and undergo four-hour HD treatments three times a week for more than 90 days.
  • Patient must be at least 18 years old. They must be able to read and write, as well as be in complete mental health.

Exclusion criteria

  • Inability to complete the surveys due to reading or hearing difficulties, actual instability of clinical condition that necessitate hospitalization, dementia, active malignancy or liver failure.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

high dialysate Na
Experimental group
Description:
They will receive high dialysate sodium (Na = 141 mmol/L) for 8 weeks.
Treatment:
Other: high dialysate Na
low dialysate Na
Experimental group
Description:
They will receive low dialysate sodium (Na = 136 mmol/L) for 8 weeks.
Treatment:
Other: low dialysate Na

Trial contacts and locations

2

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Central trial contact

Mohamed Mamdouh Elsayed, MD

Data sourced from clinicaltrials.gov

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