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

Not Applicable

Recruiting

• Conditions: Dialysis; Complications
• Interventions: Other: high dialysate Na; Other: low dialysate Na

• Registration Number: NCT05418647
• Lead Sponsor: Alexandria University

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.

Study Timeline

• Study First Submitted: 2022-06-10
• Study First Submitted QC: 2022-06-10
• Study First Posted: 2022-06-14
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-11
• Study Start: 2025-04-15
• Primary Completion: 2025-07-15
• Study Completion: 2025-08-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high dialysate Na	high dialysate Na	They will receive high dialysate sodium (Na = 141 mmol/L) for 8 weeks.
low dialysate Na	low dialysate Na	They will receive low dialysate sodium (Na = 136 mmol/L) for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Change in dialysis recovery time	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 Outcome Measures

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

Trial Locations

Locations (2)

Faculty of Medicine, Aexandria University; 🇪🇬 Alexandria, Egypt

Faculty of Medicine, Alexandria University; 🇪🇬 Alexandria, Egypt