Dialysis Disequilibrium, Fluid Overload, Hemodialysis Complication, Hypertension, Intra-dialytic Hypotension
Conditions
Keywords
hemodialysis, fluid overload, dialysis disequilibrium, intra-dialytic hypotension, dialysate sodium lowering
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).
Interventions
OTHERDialysate Sodium Lowering
Dialysate sodium is lowered until nadir sodium level is reached. Participant dialyzes at this sodium level until end of follow-up.
Sponsors
Dialysis Clinic, Inc.
InBody
Tufts Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Intradialytic Hypotension | Baseline period through study completion, an average of 6 months | 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. |
| Dialysis Dysequilibrium (Safety) | Baseline period through study completion, an average of 6 months | 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. |
| Frequency of ER visits and hospitalizations (safety) | Baseline through study completion | 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. |
| Frequency of patients treated to a dialysate Na 135 mEq/L at end of study (feasibility) | Last 2 weeks of Follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interdialytic Weight Gain | Baseline period through study completion, an average of 6 months | Determined by analysis of treatment sheets. |
| Post Dialysis Weight | Baseline period through study completion, an average of 6 months | Determined by analysis of treatment sheets. |
| Estimated Dry Weight | Baseline period through study completion, an average of 6 months | Determined by analysis of treatment sheets. |
| Pre- and post-dialysis Plasma Sodium | Baseline period through study completion, an average of 6 months | Taken from lab draws immediately before and after start of dialysis treatment. |
| Home Blood Pressure Monitoring | Baseline period through study completion, an average of 6 months | Participants will use a LifeSource blood pressure monitor to measure their blood pressure weekly at home. |
| Sodium Loss during Dialysis | Baseline period through study completion, an average of 6 months | 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. |
| Thirst and Xerostomia | Baseline through study completion, an average of 6 months | 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. |
| Pre- and Post-dialysis Sitting Blood Pressure | Baseline period through study completion, an average of 6 months | Determined by analysis of treatment sheets. |
| Dialysate Sodium | Baseline period through study completion, an average of 6 months | Sample of dialysate sodium taken 30 minutes after start of dialysis treatment. |
| Relative Blood Volume | Baseline period through study completion, an average of 6 months | Determined using CRIT LINE III monitors. |
| Bioimpedance Analysis | Baseline period through study completion, an average of 6 months | Water volume and bioimpedance results will be determined using InBodyS10 device. |
Countries
United States
Outcome results
None listed