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Clinical Trials/NCT05418647
NCT05418647
Recruiting
Not Applicable

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

Alexandria University2 sites in 1 country40 target enrollmentApril 15, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dialysis; Complications
Sponsor
Alexandria University
Enrollment
40
Locations
2
Primary Endpoint
Change in dialysis recovery time
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 15, 2025
End Date
August 15, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD

Assistant professor & lecturer

Alexandria University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Change in dialysis recovery time

Time Frame: baseline, weeks 4 and 8

By assessing the patients' responses to the single open-ended question, "How long does it take you to recover from a dialysis session?"

Secondary Outcomes

  • Change in plasma sodium concentration(baseline, weeks 4 and 8)
  • Change in the inter-dialytic weight gain(8 weeks)
  • Change in blood pressure (systolic, diastolic, mean)(8 weeks)
  • Occurrence of muscle cramps(8 weeks)
  • Occurrence of headache(8 weeks)
  • Occurrence of intradialytic hypotension(8 weeks)

Study Sites (2)

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