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DIALYSATE SODIUM CONCENTRATION AND BLOOD PRESSURE IN CHRONIC HEMODIALYSIS PATIENTS

EFFECT OF DIFFERENT DIALYSATE SODIUM CONCENTRATIONS ON BLOOD PRESSURE IN CHRONIC HEMODIALYSIS PATIENTS

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06547697
Enrollment
45
Registered
2024-08-09
Start date
2014-09-01
Completion date
2015-03-01
Last updated
2024-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

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.

Interventions

OTHERDialysate sodium concentration

Sponsors

University Medical Centre Maribor
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Peridialytic blood pressure6 months (3 periods of 2 months)Pre- and post dialysis blood pressure values

Secondary

MeasureTime frameDescription
Interdialytic weight gain6 months (3 periods of 2 months)Weight gain between dialysis sessions
Ultrafiltration6 months (3 periods of 2 months)Change of needed ultrafiltration
Serum sodium concentration6 months (3 periods of 2 months)Change of serum sodium due to the change of dialysate sodium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026