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

This study is currently recruiting participants.
Verified January 2012 by Lawson Health Research Institute
Sponsor:
Information provided by (Responsible Party):
Rita Suri, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00724633
First received: July 25, 2008
Last updated: January 19, 2012
Last verified: January 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Ambulatory blood pressure [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Ambulatory blood pressure to be taken over 24 hours at 4 week intervals throughout the study


Secondary Outcome Measures:
  • thirst [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • QOL Scores (KDQOL, mins to recovery) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • intradialytic hypotension rate, intradialytic symptoms [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • mechanistic outcomes: interdialytic weight gain, extracellular fluid water, sodium ionic mass balance [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: November 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2013 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00724633

Contacts
Contact: Rita Suri, MD, MSc 519-685-8066 rita.suri@lhsc.on.ca

Locations
Canada, Ontario
London Health Sciences Center Recruiting
London, Ontario, Canada, N6A 4G5
Contact: Rita Suri, MD, MSc     519-685-8066     rita.suri@lhsc.on.ca    
Sub-Investigator: Robert Lindsay, MD            
Sub-Investigator: Faisal Rehman, MD            
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Rita Suri, MD, MSc Lawson Health Research Institute
  More Information

No publications provided

Responsible Party: Rita Suri, MD, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00724633     History of Changes
Other Study ID Numbers: R-08-252, 15153
Study First Received: July 25, 2008
Last Updated: January 19, 2012
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on May 23, 2013