Fluid Overload in Dialysis Patients, Hypertension in Dialysis Patients
Conditions
Brief summary
This is a randomized clinical trial in which maintenance hemodialysis patients will be provided with salt restricted 'dialysis friendly' meals and compared to a control arm receiving usual care.
Detailed description
Patients randomized to the intervention arm will receive 2 months of meals plus dietary counseling. Counseling will continue for an additional 3 months while the control arm will have 5 months of usual care followed by 2 months of meal provision. Effects on interdialytic weight gain, achievement of target dry weight, intradialytic hypotension episodes, blood pressure, and a volume assessment using lung U/S to assess lung water will be measured. Salt sensitivity will be tested throughout the study. Self reported questionnaires about the burden of adhering to the low salt diet and the level of adherence with it will be completed at baseline and throughout the study. The investigator hypothesizes that the prepared meals with prime patients behavior and may alter salt taste perception and that these effects will be sustained after the prepared meals have stopped.
Interventions
OTHERSodium Restricted Meals
2 meals prepared with 2 g /day sodium restriction and adhering to dietary recommendations for a hemodialysis patients (phosphate and potassium restricted/ high protein content) 2 meals per day for first month of meal provision period followed by 1 meal per month in the second meal of meal provision period
OTHERControl
Usual Care
Sponsors
Tufts Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
BP, weight, IDH (as defined by an intra-or post dialysis BP \<90 mmHg) will be recorded per usual clinical care by the dialysis unit staff. Patients will be blinded to the salinity of the salt solutions used to test taste perception and preference.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \>18 2. Treated with outpatient hemodialysis for \>60 days 3. Mean IDWG over the past 30 days \>2 kg 4. Speaks and understands English or Chinese 5. Patient has a freezer at home with space to store at least 7 prepared meals 6. Cognitively intact (able to provide informed consent and answer questionnaires)
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Interdialytic Weight Gain throughout Length of Study | Every two weeks starting through 5months (intervention arm)/ 7 months (control arm) | A standard measurement taken for HD patients at each dialysis session to see weight gained between sessions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Intradialytic Hypotension Episodes throughout Length of Study | Every two weeks starting at baseline and through 5months (Control Arm)/ 7 months (intervention arm) | Intradialytic Systolic BP \<90 mm Hg |
Other
| Measure | Time frame | Description |
|---|---|---|
| Salt Taste Preference | through 5months (intervention arm)/ 7 months (control arm) | Testing salty solution taste preference via sip, swish, and spit and, in the opinion of the participant, selecting which solution tasted better. |
| Pre-dialysis Blood Pressure | through 5months (intervention arm)/ 7 months (control arm) | BP measurement prior to dialysis, taken for HD patients at each session |
| Rate of Achievement of Estimated Dry Weight | through 5months (intervention arm)/ 7 months (control arm) | Post-weight not greater than EDW by 0.5 kg |
| Fluid Overload | through 5months (intervention arm)/ 7 months (control arm) | As defined by lung U/S at the end of the dialysis treatment |
| Salt Taste Perception | through 5months (intervention arm)/ 7 months (control arm) | Testing salty solution taste perception via sip, swish, and spit and rating saltiness on a general Labeled Magnitude Scale ranging from Barely Detectable to Strongest Imaginable. |
Countries
United States
Outcome results
None listed