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OpenTrials
Completed

NCT Number: NCT00724633

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

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.

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Key information

Conditions

Hemodialysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

London Health Sciences Center

London, Ontario, N6A 4G5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lowering the dialysate sodium

Other

Please see above

Primary outcomes

  1. Ambulatory blood pressure

    Time frame: 3 months

    Ambulatory blood pressure to be taken over 24 hours at 4 week intervals throughout the study

Secondary outcomes

  1. thirst

    Time frame: 3 months

  2. QOL Scores (KDQOL, mins to recovery)

    Time frame: 3 months

  3. intradialytic hypotension rate, intradialytic symptoms

    Time frame: 3 months

  4. mechanistic outcomes: interdialytic weight gain, extracellular fluid water, sodium ionic mass balance

    Time frame: 3 months

Interested in participating?

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Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Jul 29, 2008
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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