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In this study the investigators aim to test the effect of lowering dialysate sodium concentration on visit-to-visit blood pressure variability in hemodialysis patients who have achieved their dry weight.
Cardiovascular diseases are considered the major cause of mortality in maintenance hemodialysis patients. Nevertheless, hypertension is recognized as an important modifiable risk factor for cardiovascular disease among hemodialysis (HD) patients.
Apart from blood pressure levels, BP variability, which reflects the fluctuation in BP, has been described as an independent risk factor that linearly associated with all-cause and cardiovascular mortality in HD patients.
BPV is categorized as either long or short term, based on the time interval over which it is considered. In the dialysis population, long-term BPV is typically defined on the basis of BP measurements taken at the start of each thrice-weekly hemodialysis treatment (interdialytic BPV). On the other hand, short-term BPV among dialysis patients can be considered in terms of variability that occurs during hemodialysis treatments (intradialytic BPV). Researchers believed that the mitigation strategies of BPV must be paid attention to.
Sodium load is associated with thirst, fluid retention, interdialysis weight gain and hypertension for hemodialysis patients, therefore the Kidney Disease Outcomes Quality Initiative (KDOQI) Clinical Practice Guideline highlighted the importance of limiting sodium intake and adequate sodium removal which is considered one of the most important goals of the dialysis therapy.
Interestingly, a recent study showed that mild decrease in dialysate sodium concentration could improve systolic blood pressure variability in HD patients at their dry weight, thus improving blood pressure complications and subsequent complications. However, whether improving sodium balance could potentially contribute to better BPV management in HD patients has not been assessed in a randomized manner. Therefore, this study aims to investigate whether lowering dialysate sodium concentration could help mitigate long term (interdialytic) BPV in hemodialysis patients in a randomized controlled manner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: standard hemodialysis. | Active Comparator | patients who will undergo standard hemodialysis (dialysate sodium concentration 143 mmoL/L) |
|
| Group B: lower dialysate sodium hemodialysis. | Active Comparator | patients who will undergo hemodialysis with lower dialysate sodium concentration (140 mmoL/L). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard hemodialysis | Procedure | patients who will undergo standard hemodialysis (dialysate sodium concentration 143 mmoL/L) |
|
| Measure | Description | Time Frame |
|---|---|---|
| blood pressure variability. | visit to visit blood pressure variability in both groups. | 2 weeks after the study duration (3 months). |
| Measure | Description | Time Frame |
|---|---|---|
| interdialytic weight gain | interdialytic weight gain | 2 weeks after the study duration (3 months). |
| antihypertensive medication regimen | antihypertensive medication regimen |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ghada El-said, Ass. Prof. | Contact | 01019080448 | ghadaalsaid222@gmail.com | |
| Hoda Abdulaziz, Lecturer | Contact | 01002878480 |
| Name | Affiliation | Role |
|---|---|---|
| Ghada El-said, Ass. Prof. | Mansoura University | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41649081 | Derived | Abdulaziz HMM, Gomaa H, El-Said G. Improvement of visit-to-visit SBP variability with lowering dialysate sodium concentration in patients undergoing hemodialysis: a randomized controlled trial. J Hypertens. 2026 Apr 1;44(4):629-635. doi: 10.1097/HJH.0000000000004243. Epub 2026 Jan 22. | |
| 39498822 | Derived | Marshall MR, Wang MY, Vandal AC, Dunlop JL. Low dialysate sodium levels for chronic haemodialysis. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD011204. doi: 10.1002/14651858.CD011204.pub3. |
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| lower dialysate sodium dialysis | Procedure | patients who will undergo hemodialysis with lower dialysate sodium concentration (140 mmoL/L) |
|
| 2 weeks after the study duration (3 months). |
| the frequency of intradialytic adverse events | the frequency of intradialytic adverse events as hypotensive crises and cramps. | 2 weeks after the study duration (3 months). |