Dialysate Sodium Lowering Trial (DeSaLT)

Tufts University

Status and phase

Completed

Phase 2

Conditions

Hypertension

Hemodialysis Complication

Intra-dialytic Hypotension

Dialysis Disequilibrium

Fluid Overload

Treatments

Other: Dialysate Sodium Lowering

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03144817

12393

Details and patient eligibility

About

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.

Full description

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).

Enrollment

44 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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