NCT02917278

Pilot Study of Nutrition in Maintenance Hemodialysis Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Purdue University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• End-Stage Renal Disease
• Meals
• Hemodialysis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Meals	High Protein renal-specific meals

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2016-09-28
• Last updated: 2021-10-19
• Results posted: 2021-05-18

Locations

1 site across 1 country: United States