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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02371018
Other study ID # 14385
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2015
Est. completion date July 2018

Study information

Verified date September 2017
Source University of Illinois at Urbana-Champaign
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date July 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Study Design


Intervention

Dietary Supplement:
Nepro
Patients will be asked to consume a single 8 oz can of Nepro

Locations

Country Name City State
United States University of Illinois Urbana Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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