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Pilot Study of Nutrition in Maintenance Hemodialysis Patients

NCT ID: NCT02917278

Last Updated: 2021-10-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-05-31

Brief Summary

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This pilot study aims to produce preliminary data on the safety of providing high-protein meals to patients during dialysis, and effects of this intervention on nutritional status and quality of life outcomes. This is a non-randomized, parallel arm study. Meals provided will follow recommended dietary guidelines for HD patients and will provide approximately 1/3 of daily recommended protein intake. Patients will be allocated to either the treatment or control group by HD shift schedule. 2 months of baseline data will be collected, followed by 9 weeks of meal intervention/control and data collection. The primary outcome will be frequency of hypotensive events during dialysis requiring intervention. Secondary outcomes will include highest and lowest systolic blood pressure during dialysis, blood biochemistries including measures of renal function, nutritional status, and electrolyte balance; dialysis compliance; fluid retention; sleep and other quality of life measures; and dietary intake data.

Detailed Description

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Conditions

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End-Stage Renal Disease Meals Hemodialysis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Meals

High-protein renal-specific meals

Group Type EXPERIMENTAL

Meals

Intervention Type DIETARY_SUPPLEMENT

High Protein renal-specific meals

Control

No Meals

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Meals

High Protein renal-specific meals

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Men and women
* Any race
* Age 18 years or older
* Maintenance hemodialysis patients

Exclusion Criteria

• Patients with dysphagia that cannot be accommodated by texture modifications, or those exclusively NPO/requiring tube feeding or parenteral feeding
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Purdue University

OTHER

Sponsor Role lead

Responsible Party

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Kathleen Hill Gallant

Assistant professor nutrition science

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kathleen M Hill Gallant, PhD

Role: PRINCIPAL_INVESTIGATOR

Purdue University

Locations

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Purdue University

West Lafayette, Indiana, United States

Site Status

Countries

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United States

References

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Choi MS, Kistler B, Wiese GN, Stremke ER, Wright AJ, Moorthi RN, Moe SM, Hill Gallant KM. Pilot Study of the Effects of High-Protein Meals During Hemodialysis on Intradialytic Hypotension in Patients Undergoing Maintenance Hemodialysis. J Ren Nutr. 2019 Mar;29(2):102-111. doi: 10.1053/j.jrn.2018.06.002. Epub 2018 Aug 11.

Reference Type RESULT
PMID: 30107974 (View on PubMed)

Study Documents

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Document Type: Meeting abstract

Abstract presented as a poster at the ASN Kidney Week 2016 (TH-PO762)

View Document

Other Identifiers

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1510016673

Identifier Type: -

Identifier Source: org_study_id