This pilot study aims to produce preliminary data on the safety of providing high-protein meals to patients during dialysis, and effects of this intervention on nutritional status and quality of life outcomes. This is a non-randomized, parallel arm study. Meals provided will follow recommended dietary guidelines for HD patients and will provide approximately 1/3 of daily recommended protein intake. Patients will be allocated to either the treatment or control group by HD shift schedule. 2 months of baseline data will be collected, followed by 9 weeks of meal intervention/control and data collection. The primary outcome will be frequency of hypotensive events during dialysis requiring intervention. Secondary outcomes will include highest and lowest systolic blood pressure during dialysis, blood biochemistries including measures of renal function, nutritional status, and electrolyte balance; dialysis compliance; fluid retention; sleep and other quality of life measures; and dietary intake data.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
19
High Protein renal-specific meals
Purdue University
West Lafayette, Indiana, United States
Hypotensive Event Frequency
frequency of hypotensive events that require intervention during dialysis
Time frame: 9 weeks
Mean Arterial Pressure (mm Hg)
Average Lowest Mean Arterial Pressure (mm Hg) over 25 dialysis sessions during the study.
Time frame: 9 weeks
Serum Albumin
Time frame: 9 weeks
Blood Urea Nitrogen
Time frame: 9 weeks
Serum Creatinine
Time frame: 9 weeks
Blood Glucose
Time frame: 9 weeks
Serum Adjusted Calcium
Time frame: 9 weeks
Serum Sodium
Time frame: 9 weeks
Serum Phosphate
Time frame: 9 weeks
Serum Chloride
Time frame: 9 weeks
Serum CO2
Time frame: 9 weeks
Serum Pre-albumin
Time frame: 9 weeks
Dialysis Absences
Absences out of 25 sessions
Time frame: 9 weeks
Interdialytic Weight Gain
Time frame: 9 weeks
Vitality Score
Vitality measured by SF-36 (Short Form 36 Health Survey) Questionnaire. Minimum-Maximum values 0-100, with higher scores meaning better outcomes.
Time frame: 9 weeks
Sleep Problems Index
Sleep Problems Index-II from the Medical Outcomes Study (MOS) Sleep Scale. Minimum-Maximum values 0-100, with higher scores meaning better outcomes.
Time frame: 9 weeks
Hunger Rating
Hunger rating on a visual analog scale of 0-10 cm. Higher values mean a better outcome.
Time frame: 9 weeks
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