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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
44
Dialysate sodium is lowered until nadir sodium level is reached. Participant dialyzes at this sodium level until end of follow-up.
DCI Boston
Boston, Massachusetts, United States
Frequency of Intradialytic Hypotension
IDH is determined by review of blood pressures (measured every 30 minutes during dialysis), symptoms (recorded by the nurse during the dialysis treatment and reviewed at Q2 weekly face to face visits by the study team) and the need for intervention (targeted ultrafiltration goal was reduced; treatment was terminated early or saline given for intradialytic hypotension. IDH is defined by any 1 (or more of the following) 1) lowest intradialytic Systolic BP \<90 mm Hg or 2) intradialytic symptoms (cramps, lightheadedness, nausea +/-vomiting, diaphoresis, loss of consciousness or seizure) OR 3) intervention performed for symptoms of IDH or lowest intradialytic BP \<90 mm Hg. The # IDH events (meeting 1 or more of the 3 criteria above) per 100 treatments will be compared across treatment arms.
Time frame: Baseline period through study completion, an average of 6 months
Dialysis Dysequilibrium (Safety)
Ascertained via self-report on a questionnaire that asks about the frequency of symptoms suggestive of DD occurring during or immediately after dialysis. The symptoms are: headache, nausea +/- vomiting, confusion, drowsiness, muscle twitching, blurred vision. There are 5 response options ranging from never through to very often for each question. The questionnaire is administered at baseline, at 6 weeks, and Q3 months thereafter. The change in frequency of each symptom will be compared across arms.
Time frame: Baseline period through study completion, an average of 6 months
Frequency of ER visits and hospitalizations (safety)
The frequency of ER visits and hospitalizations will be ascertained at Q2 weekly study visits. The # of events per time at risk will be compared across treatment arms.
Time frame: Baseline through study completion
Frequency of patients treated to a dialysate Na 135 mEq/L at end of study (feasibility)
Among those assigned to Dialysate Na 135 mEq/l as the denominator, the # actually continuing to dialyze at this level during the last two weeks of study follow-up.
Time frame: Last 2 weeks of Follow-up
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Pre- and post-dialysis Plasma Sodium
Taken from lab draws immediately before and after start of dialysis treatment.
Time frame: Baseline period through study completion, an average of 6 months
Dialysate Sodium
Sample of dialysate sodium taken 30 minutes after start of dialysis treatment.
Time frame: Baseline period through study completion, an average of 6 months
Relative Blood Volume
Determined using CRIT LINE III monitors.
Time frame: Baseline period through study completion, an average of 6 months
Bioimpedance Analysis
Water volume and bioimpedance results will be determined using InBodyS10 device.
Time frame: Baseline period through study completion, an average of 6 months
Interdialytic Weight Gain
Determined by analysis of treatment sheets.
Time frame: Baseline period through study completion, an average of 6 months
Post Dialysis Weight
Determined by analysis of treatment sheets.
Time frame: Baseline period through study completion, an average of 6 months
Estimated Dry Weight
Determined by analysis of treatment sheets.
Time frame: Baseline period through study completion, an average of 6 months
Pre- and Post-dialysis Sitting Blood Pressure
Determined by analysis of treatment sheets.
Time frame: Baseline period through study completion, an average of 6 months
Home Blood Pressure Monitoring
Participants will use a LifeSource blood pressure monitor to measure their blood pressure weekly at home.
Time frame: Baseline period through study completion, an average of 6 months
Sodium Loss during Dialysis
Calculated according to the formula: pre-dialysis total body Na - post-dialysis total body Na, where the volume of distribution in the extracellular space is estimated as 0.58\*target weight.
Time frame: Baseline period through study completion, an average of 6 months
Thirst and Xerostomia
Thirst and Xerostomia will be measured via validated, self-administered questionnaires, the 'Dialysis Thirst Inventory' and the 'Xerostomia Inventory' , respectively (BotsCP et al, Kidney International:66; 2004). Change in each inventory score from baseline to the end of the study will be compared by treatment arm.
Time frame: Baseline through study completion, an average of 6 months