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Clinical Trials/NCT06547697
NCT06547697CompletedNot Applicable

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

University Medical Centre Maribor0 sites45 target enrollmentStarted: September 1, 2014Last updated:
Conditions

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

Sponsor
University Medical Centre Maribor
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Luka Varda

Assistant

University Medical Centre Maribor

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