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

Primary Purpose

Blood Pressure, Kidney Failure, Chronic, Dietary Modification

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Nepro

About this trial

This is an interventional supportive care trial for Blood Pressure

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Illinois

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Arm Label

Standard Hemodialysis

Hemodialysis with Nutrition Supplement

Nutrition Supplement

Arm Description

Participants will be monitored during their normal hemodialysis treatment with no intervention administered

Participants will be monitored during a normal hemodialysis treatment in which they consume 1-8oz can of Nepro.

Participants will be monitored while drinking 1-8oz can of Nepro with no hemodialysis treatment.

Outcomes

Primary Outcome Measures

Changes in beat-to-beat systolic blood pressure

Beat-to-beat blood pressure will be monitored throughout the treatment by finger plethysmography

Secondary Outcome Measures

Gastrointestinal symptoms during treatment by a rating scale

A validated version of the Gastrointestinal Symptom Rating Scale will be administered

Treatment efficiency measured by urea removal

Kt/V as determined from blood urea pre- and post-hemodialysis

Full Information

NCT ID

NCT02371018

First Posted

February 5, 2015

Last Updated

August 1, 2018

Sponsor

University of Illinois at Urbana-Champaign

1. Study Identification

Unique Protocol Identification Number

NCT02371018

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

February 2015 (Actual)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Illinois at Urbana-Champaign

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Blood Pressure, Kidney Failure, Chronic, Dietary Modification

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard Hemodialysis

Arm Type

No Intervention

Arm Description

Participants will be monitored during their normal hemodialysis treatment with no intervention administered

Arm Title

Hemodialysis with Nutrition Supplement

Arm Type

Experimental

Arm Description

Participants will be monitored during a normal hemodialysis treatment in which they consume 1-8oz can of Nepro.

Arm Title

Nutrition Supplement

Arm Type

Experimental

Arm Description

Participants will be monitored while drinking 1-8oz can of Nepro with no hemodialysis treatment.

Intervention Type

Dietary Supplement

Intervention Name(s)

Nepro

Intervention Description

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

Primary Outcome Measure Information:

Title

Changes in beat-to-beat systolic blood pressure

Description

Beat-to-beat blood pressure will be monitored throughout the treatment by finger plethysmography

Time Frame

Duration of each treatment (approximately four hours), treatments will be one week apart for a total of three weeks

Secondary Outcome Measure Information:

Title

Gastrointestinal symptoms during treatment by a rating scale

Description

A validated version of the Gastrointestinal Symptom Rating Scale will be administered

Time Frame

Duration of each treatment (approximately four hours), treatments will be one week apart for a total of three weeks

Title

Treatment efficiency measured by urea removal

Description

Kt/V as determined from blood urea pre- and post-hemodialysis

Time Frame

Duration of each treatment (approximately four hours), treatments will be one week apart for a total of three weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kenneth R Wilund, PhD

Organizational Affiliation

University of Illinois at Urbana-Champaign

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Illinois

City

Urbana

State/Province

Illinois

ZIP/Postal Code

61801

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

32390133

Citation

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.

Results Reference

derived

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

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