Effect of Low Versus Standard Dialysate Sodium on 48h Ambulatory BP in Patients With Intradialyti… (NCT05430438) | Clinical Trial Compass
CompletedNot Applicable
Effect of Low Versus Standard Dialysate Sodium on 48h Ambulatory BP in Patients With Intradialytic Hypertension
Greece, Slovenia30 participantsStarted 2022-06-01
Plain-language summary
Intradialytic hypertension (IDH) is a well-recognized and established complication of hemodialysis that affects an estimated 10-15% of the dialysis population and is associated with an increased risk for cardiovascular adverse events and mortality. The major pathogenic mechanisms include volume and sodium overload, endothelial dysfunction and enhanced vasoconstriction potentially through the renin-angiotensin-aldosterone system (RAAS) and sympathetic nervous system (SNS) activation. Preliminary uncontrolled studies have demonstrated that in order to achieve proper control of blood pressure (BP) in patients with IDH, volume control with achievement of dry weight, as well as the minimization of sodium load through alteration of dialysate sodium may improve BP. To this day, 3 studies have attempted to evaluate the effect of low dialysate sodium on BP levels in patients with IDH; one study that included 16 patients, compared the effect of low (5 milliequivalent/litre (mEq/L) lower than serum sodium) versus high (5 mEq/L higher than serum sodium) dialysate sodium concentration on BP levels only during the dialysis session; another study examined the effect of low (136 mEq/L) compared to standard (140 mEq/L) sodium dialysate, again, only on peridialytic and intradialytic BP; and only one randomized cross-over study used 24h ABPM to assess the effect of individualized isonatremic vs hyponatremic vs standard dialysate sodium. Hence, the aim of this study is to examine the effect of low (137mEq/L) vs standard (140mEq/L) dialysate sodium on 48h ambulatory blood pressure monitoring (ABPM) in patients with IDH, using appropriate design of randomized crossover study. In addition this is the first study examining the effect of low dialysate sodium on ambulatory central BP, arterial stiffness indices and BP variability in patients with IDH.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult ESKD individuals treated with a standard thrice weekly hemodialysis schedule for at least 3 months
* Patients with intradialytic hypertension, defined as SBP rise ≥10 mmHg from pre- to post-dialysis in at least 4 out of 6 consecutive sessions
* Patients that are considered clinically euvolemic
* Ability to provide informed written consent
Exclusion Criteria:
* Post-dialysis SBP \<130 mmHg in at least 4 out of 6 consecutive sessions during the 2-week selection period, prior to study entry
* Previous non-functional arteriovenous fistula in the contralateral brachial arm area of the one used for vascular access that could interfere with proper ambulatory BP recording
* Patients with contraindications to receive the intervention (low dialysate sodium), i.e patients with frequent intradialytic hypotension episodes requiring intervention with fluid administration
* Pre-dialysis serum sodium \<130 or \>142 mEq/L at recruitment
* Modification of dry weight or antihypertensive treatment during one month before study initiation
* History of seizures or disequilibrium syndrome
* Hospitalization for any cause during one month before study initiation
* History of malignancy or any other condition with poor prognosis
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested low versus standard sodium in the dialysis fluid specifically for patients with intradialytic hypertension — which is blood pressure that rises during dialysis — does my blood pressure pattern during sessions fit that profile, and is that something worth discussing as a strategy for me?
2Since this trial is completed, has the data been published yet, and if so, did using lower dialysate sodium actually show a meaningful difference in 48-hour blood pressure readings outside of the dialysis center?
3If low dialysate sodium does reduce blood pressure between sessions, are there any risks I should know about — like muscle cramps, low blood pressure during dialysis, or changes in how well fluid is removed — that came up in this kind of study?
4Would trying a lower dialysate sodium approach change anything about my current dialysis prescription, and how would my care team monitor whether it's working or causing problems for me specifically?
5Are there other approaches — like adjusting my fluid intake, changing dialysis duration, or adding or changing blood pressure medications — that my doctor would recommend considering alongside or instead of a dialysate sodium adjustment?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The difference in 48h ambulatory systolic blood pressure (SBP) between low and standard dialysate sodium in patients with intradialytic hypertension
Timeframe: At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)