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

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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
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, see Learn About Clinical Studies.

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

Additional relevant MeSH terms:
Dialysis Solutions
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014