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Dialysate Sodium Lowering Trial (DeSaLT)
||The Dialysate Sodium Lowering Trial (DeSaLT)
Kidney Failure, Hypertension
||Dana Miskulin, MD
This is a pilot randomized clinical triaql in which hypertensive hemodialysis patients will be randomized to a low dialysate sodium (na) of 135 mEq/L or a standard dialysate Na or 138 mEq/L.Patients will be randomized 2:! to the low arm. Dialysate Na will be lowered 1 meE1/L every 2 weeks, as tolerated. Tolerance will be assessed by symptoms, intradialytic hyotension (IDH) episodes (systolic BP <90 or intervention for symptoms of BP drop during dialysis), achievemenbt of dry weight. The trial will last for 6 to 12 monthws, for an individual, depending on when the 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 hypotention 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, interdialystic 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, extracellular fluid volume (via bioimpedance).
- Patients undergoing thrice weekly in-center conventional HD and at least 90 days since start of hemodialysis.
- Current dialyzing at a DNa ≥ 137 mEq/L
- Hypertensive, defined by a pre-dialysis BP of > 140/90 or treatment with 1 or more antihypertensive agents.
- 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 interventions(s) (UF goal lowered, treatment stopped early, or saline given) because of IDH
Participants are enrolled from 6-12 months follow-up period. Study visits occur at baseline, end of the 6 week down-titration, 3 months, and 6 months. The following measurements will be obtained during each study visit: 1)Pre- and Post-dialysis PNa, 2) Pre- and Post-dialysis BP, IDWG and post weight values, 3) Home BP Monitoring (HBPM), 4) Thirst, dialysis disequilibrium and recovery time questionnaire, 5) The frequency of IDH and of symptoms potentially due to dialysis disequilibrium, 6) Crit line monitoring, and 7) body composition monitoring.