Acute Effects of Nutrition Supplementation on Treatment Efficiency and Hemodynamics During Dialysis

Study Overview
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Brief Summary
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The purpose of this study is to examine the effect of nutritional supplementation during hemodialysis treatment on beat-to-beat hemodynamics and treatment efficiency in a crossover design.

Detailed Description
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The consumption of food or nutritional supplements during hemodialysis treatment has been shown to improve nutritional status, improve quality of life, and reduce mortality. Despite these observations, allowing patients to eat food during hemodialysis treatment is sometimes restricted in the United States. The reasons for this restrictive policy are multi-factorial, but include concerns related to drops in blood pressure BP or a reduced efficiency of solute removal following eating during HD treatment. An alternative to eating solid food is to provide patients with liquid nutritional supplements. Clinics in the US are more likely to allow the consumption of liquid nutritional supplements, however, little is known about the effect that liquid supplements have on blood pressure or treatment efficiency. Therefore, the investigators plan to examine the effect of nutritional supplementation during hemodialysis treatment on hemodynamics and treatment efficiency in a crossover design.

Official Title
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Acute Effects of Nutrition Supplementation on Treatment Efficiency and Hemodynamics During Dialysis

Conditions
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Blood Pressure, Kidney Failure, Chronic, Dietary Modification

Intervention / Treatment
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* Dietary Supplement: Nepro


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Receiving hemodialysis treatment three times per week, on hemodialysis for greater than three months, receive medical clearance from a Nephrologists Exclusion Criteria: Milk or soy allergy, more than 4 hypotensive events requiring intervention in the last two weeks, hospitalized due to hypotension in the previous week

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Hemodialysis<br>Participants will be monitored during their normal hemodialysis treatment with no intervention administered | |
| Experimental: Hemodialysis with Nutrition Supplement<br>Participants will be monitored during a normal hemodialysis treatment in which they consume 1-8oz can of Nepro. | Dietary Supplement: Nepro<br>* Patients will be asked to consume a single 8 oz can of Nepro<br>|
| Experimental: Nutrition Supplement<br>Participants will be monitored while drinking 1-8oz can of Nepro with no hemodialysis treatment. | Dietary Supplement: Nepro<br>* Patients will be asked to consume a single 8 oz can of Nepro<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in beat-to-beat systolic blood pressure | Beat-to-beat blood pressure will be monitored throughout the treatment by finger plethysmography | Duration of each treatment (approximately four hours), treatments will be one week apart for a total of three weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal symptoms during treatment by a rating scale | A validated version of the Gastrointestinal Symptom Rating Scale will be administered | Duration of each treatment (approximately four hours), treatments will be one week apart for a total of three weeks | 
| Treatment efficiency measured by urea removal | Kt/V as determined from blood urea pre- and post-hemodialysis | Duration of each treatment (approximately four hours), treatments will be one week apart for a total of three weeks |