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.

Study Overview

• Status: Completed
• Conditions: Kidney Failure, Chronic; Blood Pressure; Dietary Modification
• Intervention / Treatment: Dietary supplement: Nepro

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Urbana, Illinois, United States, 61801
      • University of Illinois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Hemodialysis; Participants will be monitored during their normal hemodialysis treatment with no intervention administered
Experimental: Hemodialysis with Nutrition Supplement; Participants will be monitored during a normal hemodialysis treatment in which they consume 1-8oz can of Nepro.	Dietary supplement: Nepro; Patients will be asked to consume a single 8 oz can of Nepro
Experimental: Nutrition Supplement; Participants will be monitored while drinking 1-8oz can of Nepro with no hemodialysis treatment.	Dietary supplement: Nepro; Patients will be asked to consume a single 8 oz can of Nepro

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal symptoms during treatment by a rating scale	A validated version of the Gastrointestinal Symptom Rating Scale will be administered	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	Kt/V as determined from blood urea pre- and post-hemodialysis	Duration of each treatment (approximately four hours), treatments will be one week apart for a total of three weeks

Collaborators and Investigators

• Sponsor: University of Illinois at Urbana-Champaign

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: February 5, 2015
• First Submitted That Met QC Criteria: February 18, 2015
• First Posted (Estimate): February 25, 2015

Study Record Updates

• Last Update Posted (Actual): August 2, 2018
• Last Update Submitted That Met QC Criteria: August 1, 2018
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: 14385