Effect of Lowering the Dialysate Sodium on Blood Pressure in Hemodialysis Patients

Lawson Health Research Institute

Status and phase: Completed; Phase 3

Conditions: Hemodialysis

Treatments: Other: Lowering the dialysate sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT00724633

15153

R-08-252

Details and patient eligibility

About

Patients currently receiving hemodialysis will be randomized to receive 1 of 3 dialysate sodium prescriptions. The effects on blood pressure, interdialytic weight gain, thirst, and intradialytic symptoms will be assessed.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients on 3 times weekly hemodialysis of at least 3 months
• elevated average ambulatory blood pressures
• current dialysate sodium prescription 140mEq/L
• average pre-dialysis serum sodium <140mEq/L

Exclusion criteria

• frequent intradialytic hypotension
• estimated life expectancy <1 year
• non-adherence to dialysis prescription
• pregnancy
• inability or unwillingness to complete study measures

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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35 participants in 3 patient groups

1

Other group

Description:

standard dialysate Na 140 mEq/L

Treatment:

Other: Lowering the dialysate sodium

2

Active Comparator group

Description:

dialysate sodium equal to patient's predialysis serum Na

Treatment:

Other: Lowering the dialysate sodium

3

Active Comparator group

Description:

dialysate sodium lower than patient's predialysis plasma sodium

Treatment:

Other: Lowering the dialysate sodium