Pilot Study of Nutrition in Maintenance Hemodialysis Patients

Hemodialysis Clinical Trial

Official title:

Pilot Study of Nutrition in Maintenance Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02917278
• Other study ID #: 1510016673
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: May 2016

Study information

• Verified date: September 2021
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End-Stage Renal Disease
• Hemodialysis
• Kidney Failure, Chronic
• Meals

Intervention

Dietary Supplement:
• Meals
High Protein renal-specific meals

Locations

Country	Name	City	State
United States	Purdue University	West Lafayette	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Purdue University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 M — View Citation

Choi MS, Wright AJ, Moorthi RN, Moe SM, Hill Gallant, KM. Effect of high protein meals during hemodialysis on intradialytic hypotension. American Society of Nephorlogy, Kidney Week, Chicago, IL. November 2016. TH-PO762.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypotensive Event Frequency	frequency of hypotensive events that require intervention during dialysis	9 weeks
Secondary	Mean Arterial Pressure (mm Hg)	Average Lowest Mean Arterial Pressure (mm Hg) over 25 dialysis sessions during the study.	9 weeks
Secondary	Serum Albumin		9 weeks
Secondary	Blood Urea Nitrogen		9 weeks
Secondary	Serum Creatinine		9 weeks
Secondary	Blood Glucose		9 weeks
Secondary	Serum Adjusted Calcium		9 weeks
Secondary	Serum Sodium		9 weeks
Secondary	Serum Phosphate		9 weeks
Secondary	Serum Chloride		9 weeks
Secondary	Serum CO2		9 weeks
Secondary	Serum Pre-albumin		9 weeks
Secondary	Dialysis Absences	Absences out of 25 sessions	9 weeks
Secondary	Interdialytic Weight Gain		9 weeks
Secondary	Vitality Score	Vitality measured by SF-36 (Short Form 36 Health Survey) Questionnaire. Minimum-Maximum values 0-100, with higher scores meaning better outcomes.	9 weeks
Secondary	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.	9 weeks
Secondary	Hunger Rating	Hunger rating on a visual analog scale of 0-10 cm. Higher values mean a better outcome.	9 weeks