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Pilot Study of Nutrition in Maintenance Hemodialysis Patients

Primary Purpose

End-Stage Renal Disease, Meals, Hemodialysis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Meals
Sponsored by
Purdue University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for End-Stage Renal Disease

Eligibility Criteria

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

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

Sites / Locations

  • Purdue University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Meals

Control

Arm Description

High-protein renal-specific meals

No Meals

Outcomes

Primary Outcome Measures

Hypotensive Event Frequency
frequency of hypotensive events that require intervention during dialysis

Secondary Outcome Measures

Mean Arterial Pressure (mm Hg)
Average Lowest Mean Arterial Pressure (mm Hg) over 25 dialysis sessions during the study.
Serum Albumin
Blood Urea Nitrogen
Serum Creatinine
Blood Glucose
Serum Adjusted Calcium
Serum Sodium
Serum Phosphate
Serum Chloride
Serum CO2
Serum Pre-albumin
Dialysis Absences
Absences out of 25 sessions
Interdialytic Weight Gain
Vitality Score
Vitality measured by SF-36 (Short Form 36 Health Survey) Questionnaire. Minimum-Maximum values 0-100, with higher scores meaning better outcomes.
Sleep Problems Index
Sleep Problems Index-II from the Medical Outcomes Study (MOS) Sleep Scale. Minimum-Maximum values 0-100, with higher scores meaning better outcomes.
Hunger Rating
Hunger rating on a visual analog scale of 0-10 cm. Higher values mean a better outcome.

Full Information

First Posted
September 26, 2016
Last Updated
September 23, 2021
Sponsor
Purdue University
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1. Study Identification

Unique Protocol Identification Number
NCT02917278
Brief Title
Pilot Study of Nutrition in Maintenance Hemodialysis Patients
Official Title
Pilot Study of Nutrition in Maintenance Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Purdue University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-Stage Renal Disease, Meals, Hemodialysis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Meals
Arm Type
Experimental
Arm Description
High-protein renal-specific meals
Arm Title
Control
Arm Type
No Intervention
Arm Description
No Meals
Intervention Type
Dietary Supplement
Intervention Name(s)
Meals
Intervention Description
High Protein renal-specific meals
Primary Outcome Measure Information:
Title
Hypotensive Event Frequency
Description
frequency of hypotensive events that require intervention during dialysis
Time Frame
9 weeks
Secondary Outcome Measure Information:
Title
Mean Arterial Pressure (mm Hg)
Description
Average Lowest Mean Arterial Pressure (mm Hg) over 25 dialysis sessions during the study.
Time Frame
9 weeks
Title
Serum Albumin
Time Frame
9 weeks
Title
Blood Urea Nitrogen
Time Frame
9 weeks
Title
Serum Creatinine
Time Frame
9 weeks
Title
Blood Glucose
Time Frame
9 weeks
Title
Serum Adjusted Calcium
Time Frame
9 weeks
Title
Serum Sodium
Time Frame
9 weeks
Title
Serum Phosphate
Time Frame
9 weeks
Title
Serum Chloride
Time Frame
9 weeks
Title
Serum CO2
Time Frame
9 weeks
Title
Serum Pre-albumin
Time Frame
9 weeks
Title
Dialysis Absences
Description
Absences out of 25 sessions
Time Frame
9 weeks
Title
Interdialytic Weight Gain
Time Frame
9 weeks
Title
Vitality Score
Description
Vitality measured by SF-36 (Short Form 36 Health Survey) Questionnaire. Minimum-Maximum values 0-100, with higher scores meaning better outcomes.
Time Frame
9 weeks
Title
Sleep Problems Index
Description
Sleep Problems Index-II from the Medical Outcomes Study (MOS) Sleep Scale. Minimum-Maximum values 0-100, with higher scores meaning better outcomes.
Time Frame
9 weeks
Title
Hunger Rating
Description
Hunger rating on a visual analog scale of 0-10 cm. Higher values mean a better outcome.
Time Frame
9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen M Hill Gallant, PhD
Organizational Affiliation
Purdue University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Purdue University
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47907
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
De-identified individual participate data is available to other researchers upon reasonable request.
Citations:
PubMed Identifier
30107974
Citation
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.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
Meeting abstract
Available IPD/Information URL
https://www.asn-online.org/api/download/?file=/education/kidneyweek/archives/KW16Abstracts.pdf
Available IPD/Information Comments
Abstract presented as a poster at the ASN Kidney Week 2016 (TH-PO762)

Learn more about this trial

Pilot Study of Nutrition in Maintenance Hemodialysis Patients

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