DIALYSATE SODIUM CONCENTRATION AND BLOOD PRESSURE IN CHRONIC HEMODIALYSIS PATIENTS

NCT06547697 | Completed

• 1 other identifier: UMCMaribor
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Peridialytic blood pressure

  Pre- and post dialysis blood pressure values

  6 months (3 periods of 2 months)

Secondary Outcomes (3)

• 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)

Study Arms (3)

Low-to-High

EXPERIMENTAL

In the first period, the participants will be receiving a dialysate sodium concentration of 138 mmol/L, in the second period 140 mmol/L and in the third period 142 mmol/L.

Other: Dialysate sodium concentration

High-toLow

EXPERIMENTAL

In the first period, the participants will be receiving a dialysate sodium concentration of 142 mmol/L, in the second period 140 mmol/L and in the third period 138 mmol/L.

Other: Dialysate sodium concentration

No change

EXPERIMENTAL

In all three periods the participants will be recieving the same dialysate sodium concentration of 140 mmol/L.

Other: Dialysate sodium concentration

Interventions

Dialysate sodium concentration OTHER

High-toLow; Low-to-High; No change

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Patients with end-stage renal disease hemodialysis for at least 3 months

You may not qualify if:

• Non-cooperation
• Active cancer
• Hospitalization during the course of the study

Sponsors & Collaborators

• University Medical Centre Maribor: lead

Related Publications (1)

• Marshall MR, Wang MY, Vandal AC, Dunlop JL. Low dialysate sodium levels for chronic haemodialysis. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD011204. doi: 10.1002/14651858.CD011204.pub3.

  PMID: 39498822 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 9, 2024
• Study Start: September 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: August 14, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share