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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02371018
Enrollment
20
Registered
2015-02-25
Start date
2015-02-28
Completion date
2018-07-31
Last updated
2018-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure, Dietary Modification, Kidney Failure, Chronic

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.

Interventions

DIETARY_SUPPLEMENTNepro

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

Sponsors

University of Illinois at Urbana-Champaign
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in beat-to-beat systolic blood pressureDuration of each treatment (approximately four hours), treatments will be one week apart for a total of three weeksBeat-to-beat blood pressure will be monitored throughout the treatment by finger plethysmography

Secondary

MeasureTime frameDescription
Gastrointestinal symptoms during treatment by a rating scaleDuration of each treatment (approximately four hours), treatments will be one week apart for a total of three weeksA validated version of the Gastrointestinal Symptom Rating Scale will be administered
Treatment efficiency measured by urea removalDuration of each treatment (approximately four hours), treatments will be one week apart for a total of three weeksKt/V as determined from blood urea pre- and post-hemodialysis

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026