Dialysate Sodium Lowering Trial
Dialysate Sodium Lowering Trial
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.
This is a pilot randomized clinical trial in which hypertensive hemodialysis patients will be
 randomized to a low dialysate sodium (Na) of 135 mEq/L or a standard dialysate Na of 138
 mEq/L. Patients will be randomized 2:1 to the low arm. Dialysate Na will be lowered 1 mEq/L
 every 2 weeks, as tolerated. Tolerance will be assessed by symptoms, intradialytic
 hypotension (IDH) episodes (systolic BP <90 or intervention for symptoms or BP drop during
 dialysis), achievement of dry weight. The trial will last for 6 to 12 months, for an
 individual, depending on when they entered the trial. The primary outcome is feasibility and
 safety of using the lower dialysate sodium which is assessed by symptoms during or
 immediately after dialysis, intradialytic hypotension episodes and the frequency of emergency
 room visits and hospitalizations. Several secondary outcomes will be measured including blood
 pressure prior to dialysis and at home, change in plasma Na over time, dry weight,
 post-dialysis weight, interdialytic weight change, symptoms of thirst and dry mouth,
 self-reported dialysis recovery time, relative blood volume change during a single treatment
 (via 'Critline') and, in patients without an implanted electronic device, extraceullular
 fluid volume (via bioimpedance).
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