Clinical trial NCT02371018: Acute Effects of Nutrition Supplementation on Treatment Efficiency and Hemodynamics During Dialysis
Official title: Acute Effects of Nutrition Supplementation on Treatment Efficiency and Hemodynamics During Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Kidney Failure, Chronic
Dietary Modification
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2015-02-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in beat-to-beat systolic blood pressure
timeFrame: Duration of each treatment (approximately four hours), treatments will be one week apart for a total of three weeks
Secondary outcomes:
measure: Gastrointestinal symptoms during treatment by a rating scale
timeFrame: Duration of each treatment (approximately four hours), treatments will be one week apart for a total of three weeks
measure: Treatment efficiency measured by urea removal
timeFrame: Duration of each treatment (approximately four hours), treatments will be one week apart for a total of three weeks
Other outcomes:
Locations:
city: Urbana
country: United States
facility: University of Illinois
state: Illinois
Study officials:
affiliation: University of Illinois at Urbana-Champaign
name: Kenneth R Wilund, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.