DIALYSATE SODIUM CONCENTRATION AND BLOOD PRESSURE IN CHRONIC HEMODIALYSIS PATIENTS

University Medical Centre Maribor

Status: Completed

Conditions: Hypertension

Treatments: Other: Dialysate sodium concentration

Study type: Interventional

Funder types: Other

Identifiers

NCT06547697

UMCMaribor

Details and patient eligibility

About

While hypertension is one of the most common causes of end-stage renal disease, it is also present in the vast majority of hemodialysis patients. It is associated with higher cardiovascular morbidity and mortality in this group of patients. Altering dialysate sodium concentration presents a possibility of sodium balance control and blood pressure management. However, the ideal dialysate sodium concentration remains a topic for discussion.

Randomised and prospective single dialysis centre study is presented. The participants are randomly divided into 3 groups and will go through 3 periods of 2 months. A "low-to-high" dialysate sodium concentration group will start the study with 138 mmol/L in the first period, continue with 140 mmol/L in the second period and finish with 142 mmol/L. In the "high-to-low" group, the participants will go through the opposite design (reduction from 142 mmol/L to 138 mmol/L over 3 periods). One group will continue with 140 mmol/L throughout the study. Systolic and diastolic BP values before and after dialysis sessions, interdialytic weight gain, ultrafiltration, serum sodium concentration and the presence of hypotension between the groups in each period and within each group over all three periods will be evaluated.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 18 years of age
• Patients with end-stage renal disease hemodialysis for at least 3 months

Exclusion criteria

• Non-cooperation
• Active cancer
• Hospitalization during the course of the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Low-to-High

Experimental group

Description:

In the first period, the participants will be receiving a dialysate sodium concentration of 138 mmol/L, in the second period 140 mmol/L and in the third period 142 mmol/L.

Treatment:

Other: Dialysate sodium concentration

High-toLow

Experimental group

Description:

In the first period, the participants will be receiving a dialysate sodium concentration of 142 mmol/L, in the second period 140 mmol/L and in the third period 138 mmol/L.

Treatment:

Other: Dialysate sodium concentration

No change

Experimental group

Description:

In all three periods the participants will be recieving the same dialysate sodium concentration of 140 mmol/L.

Treatment:

Other: Dialysate sodium concentration