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Completed

NCT Number: NCT02371018

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nepro

Dietary Supplement

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

Primary outcomes

  1. Changes in beat-to-beat systolic blood pressure

    Time frame: Duration of each treatment (approximately four hours), treatments will be one week apart for a total of three weeks

    Beat-to-beat blood pressure will be monitored throughout the treatment by finger plethysmography

Secondary outcomes

  1. Gastrointestinal symptoms during treatment by a rating scale

    Time frame: Duration of each treatment (approximately four hours), treatments will be one week apart for a total of three weeks

    A validated version of the Gastrointestinal Symptom Rating Scale will be administered

  2. Treatment efficiency measured by urea removal

    Time frame: Duration of each treatment (approximately four hours), treatments will be one week apart for a total of three weeks

    Kt/V as determined from blood urea pre- and post-hemodialysis

Sponsors and collaborators

Lead sponsor

University of Illinois at Urbana-Champaign

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Feb 25, 2015
Registry last updated
Aug 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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