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 range18 Years

SexALL

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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

What they're measuring

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)

Trial details

NCT IDNCT05430438

SponsorAristotle University Of Thessaloniki

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-24