EFFECT OF DIFFERENT DIALYSATE SODIUM CONCENTRATIONS ON BLOOD PRESSURE IN CHRONIC HEMODIALYSIS PATIENTS
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 45
- Primary Endpoint
- Peridialytic blood pressure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Peridialytic blood pressure
Time Frame: 6 months (3 periods of 2 months)
Pre- and post dialysis blood pressure values
Secondary Outcomes
- Interdialytic weight gain(6 months (3 periods of 2 months))
- Ultrafiltration(6 months (3 periods of 2 months))
- Serum sodium concentration(6 months (3 periods of 2 months))
Investigators
Luka Varda
Assistant
University Medical Centre Maribor
