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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05418647
Enrollment
40
Registered
2022-06-14
Start date
2025-04-15
Completion date
2025-08-15
Last updated
2025-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dialysis; Complications

Keywords

hemodialysis, recovery time, dialysate Na

Brief summary

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

Detailed 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.

Interventions

OTHERlow dialysate Na

low dialysate sodium (Na = 136 mmol/L) for 8 weeks

OTHERhigh dialysate Na

high dialysate sodium (Na = 141 mmol/L) for 8 weeks

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

a single blinded study as participants will be unaware about the dialysate Na each patient receives

Intervention model description

This research is a single-blinded randomized clinical trial in which 40 haemodialysis patients will be randomly assigned to one of the study groups using block randomization with a ratio of 1:1.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in dialysis recovery timebaseline, weeks 4 and 8By assessing the patients' responses to the single open-ended question, How long does it take you to recover from a dialysis session?

Secondary

MeasureTime frameDescription
Change in the inter-dialytic weight gain8 weeksmeasuring the inter-dialytic weight gain
Change in blood pressure (systolic, diastolic, mean)8 weeksmeasuring in blood pressure (systolic, diastolic, mean)
Change in plasma sodium concentrationbaseline, weeks 4 and 8measuring plasma sodium concentration
Occurrence of muscle cramps8 weeksincidence of muscle cramps
Occurrence of headache8 weeksincidence of headache
Occurrence of intradialytic hypotension8 weeksincidence of intradialytic hypotension

Countries

Egypt

Contacts

Primary ContactMohamed Mamdouh Elsayed, MD
dr_mohamedmamdouh87@yahoo.com00201068055103

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026