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Completed

NCT Number: NCT06547697

DIALYSATE SODIUM CONCENTRATION AND BLOOD PRESSURE IN CHRONIC HEMODIALYSIS PATIENTS

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dialysate sodium concentration

Other

Primary outcomes

  1. Peridialytic blood pressure

    Time frame: 6 months (3 periods of 2 months)

    Pre- and post dialysis blood pressure values

Secondary outcomes

  1. Interdialytic weight gain

    Time frame: 6 months (3 periods of 2 months)

    Weight gain between dialysis sessions

  2. Ultrafiltration

    Time frame: 6 months (3 periods of 2 months)

    Change of needed ultrafiltration

  3. Serum sodium concentration

    Time frame: 6 months (3 periods of 2 months)

    Change of serum sodium due to the change of dialysate sodium

Sponsors and collaborators

Lead sponsor

University Medical Centre Maribor

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 9, 2024
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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