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Clinical Trials/NCT02371018
NCT02371018
Completed
Not Applicable

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

University of Illinois at Urbana-Champaign1 site in 1 country20 target enrollmentFebruary 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Blood Pressure
Sponsor
University of Illinois at Urbana-Champaign
Enrollment
20
Locations
1
Primary Endpoint
Changes in beat-to-beat systolic blood pressure
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2015
End Date
July 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Changes in beat-to-beat systolic blood pressure

Time Frame: 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 Outcomes

  • 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 Sites (1)

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