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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Hemodialysis | No Intervention | Participants will be monitored during their normal hemodialysis treatment with no intervention administered | |
| Hemodialysis with Nutrition Supplement | Experimental | Participants will be monitored during a normal hemodialysis treatment in which they consume 1-8oz can of Nepro. |
|
| Nutrition Supplement | Experimental | Participants will be monitored while drinking 1-8oz can of Nepro with no hemodialysis treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nepro | Dietary Supplement | Patients will be asked to consume a single 8 oz can of Nepro |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth R Wilund, PhD | University of Illinois at Urbana-Champaign | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois | Urbana | Illinois | 61801 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32390133 | Derived | Mah JY, Choy SW, Roberts MA, Desai AM, Corken M, Gwini SM, McMahon LP. Oral protein-based supplements versus placebo or no treatment for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020 May 11;5(5):CD012616. doi: 10.1002/14651858.CD012616.pub2. |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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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 |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |