Effect of Lowering the Dialysate Sodium on Blood Pressure in Hemodialysis Patients: a Randomized Controlled Trial.

Lawson Health Research Institute1 site in 1 country35 target enrollmentNovember 1, 2011

ConditionsHemodialysis

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Hemodialysis
Sponsor: Lawson Health Research Institute
Enrollment: 35
Locations: 1
Primary Endpoint: Ambulatory blood pressure
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

November 1, 2011

End Date

July 31, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Lawson Health Research Institute

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Ambulatory blood pressure

Time Frame: 3 months

Ambulatory blood pressure to be taken over 24 hours at 4 week intervals throughout the study

Secondary Outcomes

intradialytic hypotension rate, intradialytic symptoms(3 months)
QOL Scores (KDQOL, mins to recovery)(3 months)
thirst(3 months)
mechanistic outcomes: interdialytic weight gain, extracellular fluid water, sodium ionic mass balance(3 months)