This is a pilot randomized clinical trial in which patients treated with 3X per weekly conventional hemodialysis will be treated to a dialysate sodium 135 mEq/L vs. 138 mEq/L and followed for safety and tolerability, effects on BP and volume.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \>18 years
* Patients undergoing thrice weekly in-center conventional HD
* At least 90 days since start of hemodialysis
* Absence of pulmonary edema / signs of fluid overload on physical exam
* Currently dialyzing at a DNa \>=137 mEq/L
* Single session Kt/V \>=1.3 each month for the past 2 months
* Hypertensive, defined by a pre-dialysis BP of \>140/90 or treatment with 1 or more antihypertensive agents
* No more than 1 skipped treatment and no more than 1 session per month shortened by \>10 min
* Life expectancy \>12 months
* Able to provide Informed Consent
* Speaks and understands English
Exclusion Criteria:
* Prone to IDH, defined as IDH occurring in \>10% of treatments in the past 3 months. IDH will be defined as symptoms (e.g. cramps, dizziness, loss of consciousness) and/or intra- or post-dialytic systolic BP \<90 mm Hg and/or use of intervention(s) (UF goal lowered, treatment stopped early, or saline given) because of IDH
* Pregnancy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency of Intradialytic Hypotension
Timeframe: Baseline period through study completion, an average of 6 months
2
Dialysis Dysequilibrium (Safety)
Timeframe: Baseline period through study completion, an average of 6 months
3
Frequency of ER visits and hospitalizations (safety)
Timeframe: Baseline through study completion
4
Frequency of patients treated to a dialysate Na 135 mEq/L at end of study (feasibility)