Reducing Dialysate Sodium Effect on Blood Pressure Variability in Hemodialysis Patients

NCT05169125 | Unknown DMC

• 1 other identifier: MS.21.06.1547
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hemodialysis Patients

Keywords

sodium; variability; hemodialysis

Outcome Measures

Primary Outcomes (1)

• blood pressure variability.

  visit to visit blood pressure variability in both groups.

  2 weeks after the study duration (3 months).

Secondary Outcomes (3)

• interdialytic weight gain

  2 weeks after the study duration (3 months).

• antihypertensive medication regimen

  2 weeks after the study duration (3 months).

• the frequency of intradialytic adverse events

  2 weeks after the study duration (3 months).

Study Arms (2)

Group A: standard hemodialysis.

ACTIVE COMPARATOR

patients who will undergo standard hemodialysis (dialysate sodium concentration 143 mmoL/L)

Procedure: standard hemodialysis

Group B: lower dialysate sodium hemodialysis.

ACTIVE COMPARATOR

patients who will undergo hemodialysis with lower dialysate sodium concentration (140 mmoL/L).

Procedure: lower dialysate sodium dialysis

Interventions

standard hemodialysis PROCEDURE

patients who will undergo standard hemodialysis (dialysate sodium concentration 143 mmoL/L)

Group A: standard hemodialysis.

lower dialysate sodium dialysis PROCEDURE

patients who will undergo hemodialysis with lower dialysate sodium concentration (140 mmoL/L)

Group B: lower dialysate sodium hemodialysis.

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: 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

Study Officials

• Ghada El-said, Ass. Prof.

  Mansoura University

  STUDY CHAIR

Central Study Contacts

Ghada El-said, Ass. Prof.

CONTACT

01019080448; ghadaalsaid222@gmail.com

Hoda Abdulaziz, Lecturer

CONTACT

01002878480

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: December 23, 2021
• Study Start: January 1, 2022
• Primary Completion: May 1, 2022
• Study Completion: July 1, 2022
• Last Updated: December 23, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share