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

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

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.

Study Overview

• Status: Completed
• Conditions: Hemodialysis
• Intervention / Treatment: Other: Lowering the dialysate sodium

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 4G5
      • London Health Sciences Center

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 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 1; standard dialysate Na 140 mEq/L	Other: Lowering the dialysate sodium; Please see above
Active Comparator: 2; dialysate sodium equal to patient's predialysis serum Na	Other: Lowering the dialysate sodium; Please see above
Active Comparator: 3; dialysate sodium lower than patient's predialysis plasma sodium	Other: Lowering the dialysate sodium; Please see above

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ambulatory blood pressure	Ambulatory blood pressure to be taken over 24 hours at 4 week intervals throughout the study	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Rita Suri, MD, MSc, Lawson Health Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2011
• Primary Completion (Actual): June 6, 2017
• Study Completion (Actual): July 31, 2017

Study Registration Dates

• First Submitted: July 25, 2008
• First Submitted That Met QC Criteria: July 28, 2008
• First Posted (Estimate): July 29, 2008

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: November 2, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: blood pressure; hemodialysis; sodium; mechanisms; dialysate; thirst; interdialytic weight gain; intradialytic symptoms; extracellular fluid balance
• Additional Relevant MeSH Terms: Pharmaceutical Solutions; Dialysis Solutions
• Other Study ID Numbers: R-08-252; 15153