Reducing Dialysate Sodium Effect on Blood Pressure Variability in Hemodialysis Patients

Effect of Reducing Dialysate Sodium Concentration on Blood Pressure Variability in Hemodialysis Patients: A Randomized Controlled Trial

In this study the investigators aim to test the effect of lowering dialysate sodium concentration on visit-to-visit blood pressure variability in hemodialysis patients who have achieved their dry weight.

Study Overview

• Status: Not yet recruiting
• Conditions: Hemodialysis Patients
• Intervention / Treatment: Procedure: standard hemodialysis; Procedure: lower dialysate sodium dialysis

Detailed Description

Cardiovascular diseases are considered the major cause of mortality in maintenance hemodialysis patients. Nevertheless, hypertension is recognized as an important modifiable risk factor for cardiovascular disease among hemodialysis (HD) patients.

Apart from blood pressure levels, BP variability, which reflects the fluctuation in BP, has been described as an independent risk factor that linearly associated with all-cause and cardiovascular mortality in HD patients.

BPV is categorized as either long or short term, based on the time interval over which it is considered. In the dialysis population, long-term BPV is typically defined on the basis of BP measurements taken at the start of each thrice-weekly hemodialysis treatment (interdialytic BPV). On the other hand, short-term BPV among dialysis patients can be considered in terms of variability that occurs during hemodialysis treatments (intradialytic BPV). Researchers believed that the mitigation strategies of BPV must be paid attention to.

Sodium load is associated with thirst, fluid retention, interdialysis weight gain and hypertension for hemodialysis patients, therefore the Kidney Disease Outcomes Quality Initiative (KDOQI) Clinical Practice Guideline highlighted the importance of limiting sodium intake and adequate sodium removal which is considered one of the most important goals of the dialysis therapy.

Interestingly, a recent study showed that mild decrease in dialysate sodium concentration could improve systolic blood pressure variability in HD patients at their dry weight, thus improving blood pressure complications and subsequent complications. However, whether improving sodium balance could potentially contribute to better BPV management in HD patients has not been assessed in a randomized manner. Therefore, this study aims to investigate whether lowering dialysate sodium concentration could help mitigate long term (interdialytic) BPV in hemodialysis patients in a randomized controlled manner.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ghada El-said, Ass. Prof.; Phone Number: 01019080448; Email: ghadaalsaid222@gmail.com
• Study Contact Backup: Name: Hoda Abdulaziz, Lecturer; Phone Number: 01002878480

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients' age ≥18 years
• Patients who had been on regular hemodialysis for at least 3 months.
• Patients' residual daily urine output is less than 100 mL/day.
• Pre study one week average systolic BP ≥120 mmHg but ≤ 180 mmHg.
• Patients who have achieved their dry weight as assessed by clinical examination.
• Predialytic serum sodium level ≥ 140mmol/l.
• Kt/V ≥ 1.2

Exclusion Criteria:

• Patients who have advanced heart failure or permanent atrial fibrillation decompensated liver disease, neoplastic illness, overt edema.
• History of acute cardiovascular accidents or infections during 3 months preceding entry into the study.
• Patients prone to hypotension or other intradialytic adverse events.
• Patients participating in another interventional study that may affect blood pressure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A: standard hemodialysis.; patients who will undergo standard hemodialysis (dialysate sodium concentration 143 mmoL/L)	Procedure: standard hemodialysis; patients who will undergo standard hemodialysis (dialysate sodium concentration 143 mmoL/L)
Active Comparator: Group B: lower dialysate sodium hemodialysis.; patients who will undergo hemodialysis with lower dialysate sodium concentration (140 mmoL/L).	Procedure: lower dialysate sodium dialysis; patients who will undergo hemodialysis with lower dialysate sodium concentration (140 mmoL/L)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood pressure variability.	visit to visit blood pressure variability in both groups.	2 weeks after the study duration (3 months).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
interdialytic weight gain	interdialytic weight gain	2 weeks after the study duration (3 months).
antihypertensive medication regimen	antihypertensive medication regimen	2 weeks after the study duration (3 months).
the frequency of intradialytic adverse events	the frequency of intradialytic adverse events as hypotensive crises and cramps.	2 weeks after the study duration (3 months).

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Ghada El-said, Ass. Prof., Mansoura University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: November 10, 2021
• First Submitted That Met QC Criteria: December 22, 2021
• First Posted (Actual): December 23, 2021

Study Record Updates

• Last Update Posted (Actual): December 23, 2021
• Last Update Submitted That Met QC Criteria: December 22, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: hemodialysis; variability; sodium
• Additional Relevant MeSH Terms: Pharmaceutical Solutions; Dialysis Solutions
• Other Study ID Numbers: MS.21.06.1547

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No