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

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ClinicalTrials.gov Identifier: NCT00724633
Recruitment Status : Completed
First Posted : July 29, 2008
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Lawson Health Research Institute

Tracking Information
First Submitted Date  ICMJE July 25, 2008
First Posted Date  ICMJE July 29, 2008
Last Update Posted Date November 6, 2017
Actual Study Start Date  ICMJE November 1, 2011
Actual Primary Completion Date June 6, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2012)
Ambulatory blood pressure [ Time Frame: 3 months ]
Ambulatory blood pressure to be taken over 24 hours at 4 week intervals throughout the study
Original Primary Outcome Measures  ICMJE
 (submitted: July 28, 2008)
home blood pressure [ Time Frame: 3 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Lowering the Dialysate Sodium on Blood Pressure in Hemodialysis Patients
Official Title  ICMJE Effect of Lowering the Dialysate Sodium on Blood Pressure in Hemodialysis Patients: a Randomized Controlled Trial.
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hemodialysis
Intervention  ICMJE Other: Lowering the dialysate sodium
Please see above
Study Arms  ICMJE
  • 1
    standard dialysate Na 140 mEq/L
    Intervention: Other: Lowering the dialysate sodium
  • Active Comparator: 2
    dialysate sodium equal to patient's predialysis serum Na
    Intervention: Other: Lowering the dialysate sodium
  • Active Comparator: 3
    dialysate sodium lower than patient's predialysis plasma sodium
    Intervention: Other: Lowering the dialysate sodium
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 2, 2017)
35
Original Estimated Enrollment  ICMJE
 (submitted: July 28, 2008)
75
Actual Study Completion Date  ICMJE July 31, 2017
Actual Primary Completion Date June 6, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00724633
Other Study ID Numbers  ICMJE R-08-252
15153
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lawson Health Research Institute
Study Sponsor  ICMJE Lawson Health Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rita Suri, MD, MSc Lawson Health Research Institute
PRS Account Lawson Health Research Institute
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP