Reducing Dialysate Sodium Effect on Blood Pressure Variability in Hemodialysis Patients

NCT ID: NCT05169125

Last Updated: 2021-12-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2022-07-31

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.

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.

Conditions

Hemodialysis Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A: standard hemodialysis.

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

Group Type: ACTIVE_COMPARATOR

standard hemodialysis

Intervention Type: PROCEDURE

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

Group B: lower dialysate sodium hemodialysis.

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

Group Type: ACTIVE_COMPARATOR

lower dialysate sodium dialysis

Intervention Type: PROCEDURE

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

Interventions

standard hemodialysis

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

Intervention Type: PROCEDURE

lower dialysate sodium dialysis

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Hadeer Tarek Abdelaziz Gomaa

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ghada El-said, Ass. Prof.

Role: STUDY_CHAIR

Mansoura University

Central Contacts

Ghada El-said, Ass. Prof.

Role: CONTACT

ghadaalsaid222@gmail.com

01019080448

Hoda Abdulaziz, Lecturer

Role: CONTACT

01002878480

References

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.

Reference Type: DERIVED

PMID: 39498822 (View on PubMed)

Other Identifiers

MS.21.06.1547

Identifier Type: -

Identifier Source: org_study_id