NCT00724633.
Trial name or title | Effect of lowering the dialysate sodium on blood pressure in haemodialysis patients: a randomized controlled trial |
Methods | Randomised, parallel‐assignment, double‐blind clinical trial |
Participants | Canada Sample size 150 patients Eligibility criteria: aged 18 years and older; on 3 times weekly HD of at least 3 months; elevated average ambulatory BP; current dialysate [Na+] prescription 140 mEq/L; average predialysis serum [Na+] < 140 mEq/L Exclusion criteria: frequent intradialytic hypotension; estimated life expectancy < 1 year; non‐adherence to dialysis prescription pregnancy; inability or unwillingness to complete study measures |
Interventions | HD regimen: not reported Control: dialysate [Na+] 140 mM Intervention 1: dialysate [Na+] = patient predialysis serum [Na+] Intervention 2: dialysate [Na+] < patient predialysis serum [Na+] Duration: 3 months |
Outcomes | Primary outcome is ambulatory BP Secondary outcomes Thirst HRQoL scores by KDQoL IDWG Intradialytic hypotension EFV Sodium ionic mass |
Starting date | November 2011 |
Contact information | rita.suri@lhsc.on.ca |
Notes | The recruitment status of this study is unknown because the information has not been verified recently. Was due for completion November 2014. |