DIALYSATE SODIUM CONCENTRATION AND BLOOD PRESSURE IN CHRONIC HEMODIALYSIS PATIENTS

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Other: Dialysate sodium concentration

• Registration Number: NCT06547697
• Lead Sponsor: University Medical Centre Maribor

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-01
• Primary Completion: 2015-03-01
• Study Completion: 2015-03-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-07
• Study First Submitted QC: 2024-08-07
• Study First Posted: 2024-08-09
• Last Update Submitted: 2024-08-11
• Last Update Posted: 2024-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-to-High	Dialysate sodium concentration	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.
High-toLow	Dialysate sodium concentration	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.
No change	Dialysate sodium concentration	In all three periods the participants will be recieving the same dialysate sodium concentration of 140 mmol/L.

Primary Outcome Measures

Name	Time	Method
Peridialytic blood pressure	6 months (3 periods of 2 months)	Pre- and post dialysis blood pressure values

Secondary Outcome Measures

Name	Time	Method
Interdialytic weight gain	6 months (3 periods of 2 months)	Weight gain between dialysis sessions
Ultrafiltration	6 months (3 periods of 2 months)	Change of needed ultrafiltration
Serum sodium concentration	6 months (3 periods of 2 months)	Change of serum sodium due to the change of dialysate sodium