Effect of Low Versus Standard Dialysate Sodium on 48h Ambulatory BP in Patients With Intradialytic Hypertension

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.

Conditions

• Intradialytic Hypertension
• End Stage Kidney Disease

Interventions

OTHER

dialysis with low dialysate sodium concentration

Patients will undergo 4 dialysis sessions with a dialysate sodium concentration of 137 mEq/L. The modification of dialysate sodium concentration will be monitored through alteration of sodium conductivity

OTHER

dialysis with standard dialysate sodium concentration

Patients will undergo 4 dialysis sessions with a dialysate sodium concentration of 140 mEq/L. The modification of dialysate sodium concentration will be monitored through alteration of sodium conductivity

Sponsors & Collaborators

• Aristotle University Of Thessaloniki

  lead OTHER

Principal Investigators

• Pantelis Sarafidis, Prof · Aristotle University Of Thessaloniki

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-01

Primary Completion

2023-07-24

Completion

2023-07-24

Countries

• Greece
• Slovenia

Study Locations