We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00724633
First Posted: July 29, 2008
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lawson Health Research Institute
  Purpose
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.

Condition Intervention Phase
Hemodialysis Other: Lowering the dialysate sodium Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Lowering the Dialysate Sodium on Blood Pressure in Hemodialysis Patients: a Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Ambulatory blood pressure [ Time Frame: 3 months ]
    Ambulatory blood pressure to be taken over 24 hours at 4 week intervals throughout the study


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

Enrollment: 35
Actual Study Start Date: November 1, 2011
Study Completion Date: July 31, 2017
Primary Completion Date: June 6, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00724633


Locations
Canada, Ontario
London Health Sciences Center
London, Ontario, Canada, N6A 4G5
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Rita Suri, MD, MSc Lawson Health Research Institute
  More Information

Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00724633     History of Changes
Other Study ID Numbers: R-08-252
15153
First Submitted: July 25, 2008
First Posted: July 29, 2008
Last Update Posted: November 6, 2017
Last Verified: November 2017

Keywords provided by Lawson Health Research Institute:
dialysate
sodium
hemodialysis
blood pressure
thirst
intradialytic symptoms
interdialytic weight gain
extracellular fluid balance
mechanisms

Additional relevant MeSH terms:
Dialysis Solutions
Pharmaceutical Solutions