Comparing Nutritional Status of In-centre Nocturnal Hemodialysis Patients to Conventional Hemodialysis Patients

• Conditions: End Stage Renal Failure on Dialysis
• Interventions: Other: No intervention - observational study

• Registration Number: NCT02887391
• Lead Sponsor: University of Calgary

Brief Summary

Although hemodialysis is life-saving, unfortunately, people on dialysis often have declining health, quality of life as well as poor nutritional status. Hemodialysis patients must follow a very restrictive diet, and many patients do not eat well and usually report poor appetites. A new approach to dialysis is being used in some hospitals in Alberta and elsewhere, called in-centre nocturnal hemodialysis. This in-centre nocturnal dialysis allows people to receive their dialysis at a hospital or clinic while they sleep. Since this in-centre nocturnal dialysis gives people 8-hour hemodialysis treatment 3 times per week (24 hours of dialysis per week) the patients have better removal of the waste products from their bodies than conventional hemodialysis (an average of 12 hours per week). Also of importance, when using in-centre nocturnal dialysis, people will have more time during the day to work, spend with family, as well as have time to shop for food, to cook and even to eat, which in turn will likely result in improvement in the quality of their lives. This study will follow 10 patients on conventional dialysis and 10 patients on in-centre nocturnal dialysis for 6 months and compare their food intake, muscle mass, weight, body mass index (BMI) and nutrition-related lab tests. The purpose of this study is to determine whether there is an improvement in the nutritional status of the in-centre nocturnal hemodialysis patients compared to the nutritional status of conventional hemodialysis patients.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-01
• Status Verified: 2016-08
• Study First Submitted: 2016-08-15
• Study First Submitted QC: 2016-08-29
• Last Update Submitted: 2016-08-29
• Study First Posted: 2016-09-02
• Last Update Posted: 2016-09-02
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• >18 years of age
• referred to the in-centre nocturnal hemodialysis program
• medically stable
• undergo hemodialysis three to four times per week for a minimum of three hours per week
• able to provide written, informed consent

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Exclusion Criteria

• younger than 18 years old
• have a current diagnosis with palliative status (e.g. cancer) or have active disease
• have had a prolonged hospitalization (>3 weeks) within the previous 3 months

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
In-Centre Nocturnal Hemodialysis	No intervention - observational study	8 hours of hemodialysis 3x per week (24 hours hemodialysis/week)
Conventional Hemodialysis	No intervention - observational study	Control group 4 hours of hemodialysis 3x per week (12 hours hemodialysis/week)

Primary Outcome Measures

Name	Time	Method
Malnutrition Inflammation Score (MIS)	Baseline & 6 months	A survey/tool that uses both subjective global assessment and objective laboratory measures to evaluate nutritional status. Change from baseline MIS at 6 months will be measured in both groups.

Secondary Outcome Measures

Name	Time	Method
Interdialytic Weight Gain	Baseline & 6 months	Measurement of fluid weight gain between dialysis sessions; Will be measured in both groups at baseline and after 6 months.
Triceps Skinfold Thickness	Baseline & 6 months	Triceps skinfold thickness will be used to assess changes in muscle and fat mass over time. Will be measured in both groups at baseline and after 6 months.
Dietary Intake	Baseline & 6 months	3 day food records will be administered to document changes in dietary intake. Will be measured at baseline and change after 6 months in both groups.
Appetite	Baseline & 6 months	Simplified Nutritional Appetite Questionnaire (SNAQ) will be administered to document changes in appetite. Will be measured at baseline and change after 6 months in both groups.
Handgrip Strength	Baseline & 6 months	Handgrip strength will be used to assess changes in muscle strength over time. Will be measured in both groups at baseline and after 6 months.
Bio-electrical Impedance	Baseline & 6 months	This is completed as one measurement to assess body composition (fat, fluid, muscle). Will be measured at baseline and after 6 months in both groups.
Mid Arm (Muscle) Circumference	Baseline & 6 months	Mid arm (muscle) circumference will be used to assess changes in muscle and fat mass over time. Will be measured in both groups at baseline and after 6 months.
Quality of Life	Baseline & 6 months	KDQOL (SF-36) will be used to measure the quality of life in both groups at baseline and change after 6 months.
C-reactive protein (CRP)	Baseline & 6 months	C-reactive protein will be measured as part of hemodialysis standard of care. Change in baseline CRP will be evaluated at 6 months.
Total iron binding capacity (TIBC)	Baseline & 6 months	Total iron binding capacity (TIBC) will be measured as part of hemodialysis standard of care. Change in baseline TIBC will be evaluated at 6 months.
Body Mass Index (BMI)	Baseline & 6 months	Body Mass Index (BMI) will be used to assess change in weight over time. Will be measured in both groups at baseline and after 6 months.
Phosphate Binders	Baseline & 6 months	Changes in use and number/dose of phosphate binders will be measured at baseline and after 6 months in both groups.
Serum Albumin	Baseline & 6 months	Serum albumin will be measured as part of hemodialysis standard of care. Change in baseline serum albumin will be evaluated at 6 months.

Trial Locations

Locations (1)

Alberta Health Services Southern Alberta Renal Program; 🇨🇦 Calgary, Alberta, Canada