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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Notify MeKey information
Conditions
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
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
Time frame: 6 months (3 periods of 2 months)
Weight gain between dialysis sessions
-
Ultrafiltration
Time frame: 6 months (3 periods of 2 months)
Change of needed ultrafiltration
-
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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