Pilot Study of Nutrition in Maintenance Hemodialysis Patients

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study of Nutrition in Maintenance Hemodialysis Patients

Conditions
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End-Stage Renal Disease, Meals, Hemodialysis

Intervention / Treatment
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* Dietary Supplement: Meals


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women Any race Age 18 years or older Maintenance hemodialysis patients Exclusion Criteria: • Patients with dysphagia that cannot be accommodated by texture modifications, or those exclusively NPO/requiring tube feeding or parenteral feeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meals<br>High-protein renal-specific meals | Dietary Supplement: Meals<br>* High Protein renal-specific meals<br>|
| No Intervention: Control<br>No Meals | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypotensive Event Frequency | frequency of hypotensive events that require intervention during dialysis | 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Arterial Pressure (mm Hg) | Average Lowest Mean Arterial Pressure (mm Hg) over 25 dialysis sessions during the study. | 9 weeks | 
| Serum Albumin |  | 9 weeks | 
| Blood Urea Nitrogen |  | 9 weeks | 
| Serum Creatinine |  | 9 weeks | 
| Blood Glucose |  | 9 weeks | 
| Serum Adjusted Calcium |  | 9 weeks | 
| Serum Sodium |  | 9 weeks | 
| Serum Phosphate |  | 9 weeks | 
| Serum Chloride |  | 9 weeks | 
| Serum CO2 |  | 9 weeks | 
| Serum Pre-albumin |  | 9 weeks | 
| Dialysis Absences | Absences out of 25 sessions | 9 weeks | 
| Interdialytic Weight Gain |  | 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. | 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. | 9 weeks | 
| Hunger Rating | Hunger rating on a visual analog scale of 0-10 cm. Higher values mean a better outcome. | 9 weeks |