Pilot Study of Nutrition in Maintenance Hemodialysis Patients
Status
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Details and patient eligibility
About
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.
Enrollment
Sex
Ages
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
19 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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