Effect of Low Versus High Dialysate Sodium Concentration During Hemodialysis on Dialysis Recovery Time: A Prospective Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Alexandria University
- Enrollment
- 40
- Locations
- 3
- Primary Endpoint
- Change in dialysis recovery time
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
a single blinded study as participants will be unaware about the dialysate Na each patient receives
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
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)
Investigators
Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD
Assistant professor & lecturer
Alexandria University