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

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

Detailed Description
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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.

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

Conditions
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Dialysis; Complications

Intervention / Treatment
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* Other: high dialysate Na
* Other: low dialysate Na


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high dialysate Na<br>They will receive high dialysate sodium (Na = 141 mmol/L) for 8 weeks. | Other: high dialysate Na<br>* high dialysate sodium (Na = 141 mmol/L) for 8 weeks<br>|
| Experimental: low dialysate Na<br>They will receive low dialysate sodium (Na = 136 mmol/L) for 8 weeks. | Other: low dialysate Na<br>* low dialysate sodium (Na = 136 mmol/L) for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in dialysis recovery time | By assessing the patients' responses to the single open-ended question, How long does it take you to recover from a dialysis session? | baseline, weeks 4 and 8 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemodialysis, recovery time, dialysate Na