Acute Effects of Nutrition Supplementation on Treatment Efficiency and Hemodynamics During Dialysis
1 other identifier
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 5, 2015
CompletedFirst Posted
Study publicly available on registry
February 25, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedAugust 2, 2018
September 1, 2017
2.8 years
February 5, 2015
August 1, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Gastrointestinal symptoms during treatment by a rating scale
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
Duration of each treatment (approximately four hours), treatments will be one week apart for a total of three weeks
Study Arms (3)
Standard Hemodialysis
NO INTERVENTIONParticipants will be monitored during their normal hemodialysis treatment with no intervention administered
Hemodialysis with Nutrition Supplement
EXPERIMENTALParticipants will be monitored during a normal hemodialysis treatment in which they consume 1-8oz can of Nepro.
Nutrition Supplement
EXPERIMENTALParticipants will be monitored while drinking 1-8oz can of Nepro with no hemodialysis treatment.
Interventions
Patients will be asked to consume a single 8 oz can of Nepro
Eligibility Criteria
You may qualify if:
- Receiving hemodialysis treatment three times per week, on hemodialysis for greater than three months, receive medical clearance from a Nephrologists
You may not qualify if:
- Milk or soy allergy, more than 4 hypotensive events requiring intervention in the last two weeks, hospitalized due to hypotension in the previous week
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Illinois
Urbana, Illinois, 61801, United States
Related Publications (1)
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.
PMID: 32390133DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth R Wilund, PhD
University of Illinois at Urbana-Champaign
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2015
First Posted
February 25, 2015
Study Start
February 1, 2015
Primary Completion
December 1, 2017
Study Completion
July 1, 2018
Last Updated
August 2, 2018
Record last verified: 2017-09