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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2018-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Health Effects of oraL Protein Supplements in HD (The HELPS-HD Trial)

NCT02933151

End Stage Renal Disease

COMPLETED NA

Efficacy of Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation in Hemodialysis Patients

NCT01837238

Complication of Dialysis Chronic Kidney Disease Muscle Loss +1 more

COMPLETED NA

Acute Effects of Intradialytic Exercise on Cardiovascular Function in Hemodialysis Patients

NCT02753868

Kidney Failure

COMPLETED NA

Muscle Protein Synthesis in Dialysis Patients

NCT03478722

Muscle Loss

COMPLETED

Muscle Status to Oral Nutritional Supplementation in Hemodialysis Patients With Protein Energy Wasting

NCT04789031

Muscle Wasting End Stage Renal Disease on Dialysis

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Blood Pressure Kidney Failure, Chronic Dietary Modification

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard Hemodialysis

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Hemodialysis with Nutrition Supplement

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

Group Type EXPERIMENTAL

Nepro

Intervention Type DIETARY_SUPPLEMENT

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

Nutrition Supplement

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

Group Type EXPERIMENTAL

Nepro

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nepro

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No