Pilot Study of Nutrition in Maintenance Hemodialysis Patients

Not Applicable

Completed

• Conditions: End-Stage Renal Disease; Meals; Hemodialysis
• Interventions: Dietary Supplement: Meals

• Registration Number: NCT02917278
• Lead Sponsor: Purdue University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Study First Submitted: 2016-09-26
• Study First Submitted QC: 2016-09-26
• Study First Posted: 2016-09-28
• Results First Submitted: 2020-08-31
• Results First Submitted QC: 2021-04-26
• Results First Posted: 2021-05-18
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-23
• Last Update Posted: 2021-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Meals	Meals	High-protein renal-specific meals

Primary Outcome Measures

Name	Time	Method
Hypotensive Event Frequency	9 weeks	frequency of hypotensive events that require intervention during dialysis

Secondary Outcome Measures

Name	Time	Method
Serum Sodium	9 weeks
Hunger Rating	9 weeks	Hunger rating on a visual analog scale of 0-10 cm. Higher values mean a better outcome.
Mean Arterial Pressure (mm Hg)	9 weeks	Average Lowest Mean Arterial Pressure (mm Hg) over 25 dialysis sessions during the study.
Serum Albumin	9 weeks
Blood Urea Nitrogen	9 weeks
Serum Pre-albumin	9 weeks
Dialysis Absences	9 weeks	Absences out of 25 sessions
Serum Phosphate	9 weeks
Vitality Score	9 weeks	Vitality measured by SF-36 (Short Form 36 Health Survey) Questionnaire. Minimum-Maximum values 0-100, with higher scores meaning better outcomes.
Serum Creatinine	9 weeks
Serum Chloride	9 weeks
Serum CO2	9 weeks
Sleep Problems Index	9 weeks	Sleep Problems Index-II from the Medical Outcomes Study (MOS) Sleep Scale. Minimum-Maximum values 0-100, with higher scores meaning better outcomes.
Blood Glucose	9 weeks
Serum Adjusted Calcium	9 weeks
Interdialytic Weight Gain	9 weeks

Trial Locations

Locations (1)

Purdue University; 🇺🇸 West Lafayette, Indiana, United States