Clinical trial NCT02917278: Pilot Study of Nutrition in Maintenance Hemodialysis Patients
Official title: Pilot Study of Nutrition in Maintenance Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End-Stage Renal Disease
Meals
Hemodialysis
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2016-09-28
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Hypotensive Event Frequency
timeFrame: 9 weeks
Secondary outcomes:
measure: Mean Arterial Pressure (mm Hg)
timeFrame: 9 weeks
measure: Serum Albumin
timeFrame: 9 weeks
measure: Blood Urea Nitrogen
timeFrame: 9 weeks
measure: Serum Creatinine
timeFrame: 9 weeks
measure: Blood Glucose
timeFrame: 9 weeks
measure: Serum Adjusted Calcium
timeFrame: 9 weeks
measure: Serum Sodium
timeFrame: 9 weeks
measure: Serum Phosphate
timeFrame: 9 weeks
measure: Serum Chloride
timeFrame: 9 weeks
measure: Serum CO2
timeFrame: 9 weeks
measure: Serum Pre-albumin
timeFrame: 9 weeks
measure: Dialysis Absences
timeFrame: 9 weeks
measure: Interdialytic Weight Gain
timeFrame: 9 weeks
measure: Vitality Score
timeFrame: 9 weeks
measure: Sleep Problems Index
timeFrame: 9 weeks
measure: Hunger Rating
timeFrame: 9 weeks
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: Purdue University
name: Kathleen M Hill Gallant, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.