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

Hemodialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00724633
• Other study ID #: R-08-252
• Secondary ID: 15153
• Status: Completed
• Phase: Phase 3
• First received: July 25, 2008
• Last updated: November 2, 2017
• Start date: November 1, 2011
• Est. completion date: July 31, 2017

Study information

• Verified date: November 2017
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: July 31, 2017
• Est. primary completion date: June 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemodialysis

Intervention

Other:
• Lowering the dialysate sodium
Please see above

Locations

Country	Name	City	State
Canada	London Health Sciences Center	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ambulatory blood pressure	Ambulatory blood pressure to be taken over 24 hours at 4 week intervals throughout the study	3 months
Secondary	thirst		3 months
Secondary	QOL Scores (KDQOL, mins to recovery)		3 months
Secondary	intradialytic hypotension rate, intradialytic symptoms		3 months
Secondary	mechanistic outcomes: interdialytic weight gain, extracellular fluid water, sodium ionic mass balance		3 months