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

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02371018
• Other study ID #: 14385
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: July 2018

Study information

• Verified date: September 2017
• Source: University of Illinois at Urbana-Champaign
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Dietary Modification
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Dietary Supplement:
• Nepro
Patients will be asked to consume a single 8 oz can of Nepro

Locations

Country	Name	City	State
United States	University of Illinois	Urbana	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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