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

Not Applicable

Completed

• Conditions: Kidney Failure, Chronic; Blood Pressure; Dietary Modification
• Interventions: Dietary Supplement: Nepro

• Registration Number: NCT02371018
• Lead Sponsor: University of Illinois at Urbana-Champaign

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.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-05
• Study First Submitted QC: 2015-02-18
• Study First Posted: 2015-02-25
• Status Verified: 2017-09
• Primary Completion: 2017-12
• Study Completion: 2018-07
• Last Update Submitted: 2018-08-01
• Last Update Posted: 2018-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hemodialysis with Nutrition Supplement	Nepro	Participants will be monitored during a normal hemodialysis treatment in which they consume 1-8oz can of Nepro.
Nutrition Supplement	Nepro	Participants will be monitored while drinking 1-8oz can of Nepro with no hemodialysis treatment.

Primary Outcome Measures

Name	Time	Method
Changes in beat-to-beat systolic blood pressure	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 Outcome Measures

Name	Time	Method
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	A validated version of the Gastrointestinal Symptom Rating Scale will be administered
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	Kt/V as determined from blood urea pre- and post-hemodialysis

Trial Locations

Locations (1)

University of Illinois; 🇺🇸 Urbana, Illinois, United States