Clinical trial NCT03144817: Dialysate Sodium Lowering Trial
Official title: Dialysate Sodium Lowering Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hemodialysis Complication
Fluid Overload
Dialysis Disequilibrium
Intra-dialytic Hypotension
Hypertension
Keywords: hemodialysis
fluid overload
dialysis disequilibrium
intra-dialytic hypotension
dialysate sodium lowering
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
Collaborators: name: Dialysis Clinic, Inc.
name: InBody
First posted: 2017-05-09
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of Intradialytic Hypotension
timeFrame: Baseline period through study completion, an average of 6 months
measure: Dialysis Dysequilibrium (Safety)
timeFrame: Baseline period through study completion, an average of 6 months
measure: Frequency of ER visits and hospitalizations (safety)
timeFrame: Baseline through study completion
measure: Frequency of patients treated to a dialysate Na 135 mEq/L at end of study (feasibility)
timeFrame: Last 2 weeks of Follow-up
Secondary outcomes:
measure: Pre- and post-dialysis Plasma Sodium
timeFrame: Baseline period through study completion, an average of 6 months
measure: Dialysate Sodium
timeFrame: Baseline period through study completion, an average of 6 months
measure: Relative Blood Volume
timeFrame: Baseline period through study completion, an average of 6 months
measure: Bioimpedance Analysis
timeFrame: Baseline period through study completion, an average of 6 months
measure: Interdialytic Weight Gain
timeFrame: Baseline period through study completion, an average of 6 months
measure: Post Dialysis Weight
timeFrame: Baseline period through study completion, an average of 6 months
measure: Estimated Dry Weight
timeFrame: Baseline period through study completion, an average of 6 months
measure: Pre- and Post-dialysis Sitting Blood Pressure
timeFrame: Baseline period through study completion, an average of 6 months
measure: Home Blood Pressure Monitoring
timeFrame: Baseline period through study completion, an average of 6 months
measure: Sodium Loss during Dialysis
timeFrame: Baseline period through study completion, an average of 6 months
measure: Thirst and Xerostomia
timeFrame: Baseline through study completion, an average of 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: DCI Boston
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Dana Miskulin, MD
role: PRINCIPAL_INVESTIGATOR
References: