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

Study Overview
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Brief Summary
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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.

Official Title
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Comparing Nutritional Status of In-centre Nocturnal Hemodialysis Patients to Conventional Hemodialysis Patients: A Prospective Cohort Study

Conditions
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End Stage Renal Failure on Dialysis

Intervention / Treatment
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* Other: No intervention - observational study


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Conventional Hemodialysis<br>Control group 4 hours of hemodialysis 3x per week (12 hours hemodialysis/week) | Other: No intervention - observational study<br>* No intervention - observational study<br>|
| In-Centre Nocturnal Hemodialysis<br>8 hours of hemodialysis 3x per week (24 hours hemodialysis/week) | Other: No intervention - observational study<br>* No intervention - observational study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Malnutrition Inflammation Score (MIS) | 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. | Baseline & 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | KDQOL (SF-36) will be used to measure the quality of life in both groups at baseline and change after 6 months. | Baseline & 6 months | 
| Dietary Intake | 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. | Baseline & 6 months | 
| Appetite | 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. | Baseline & 6 months | 
| Interdialytic Weight Gain | Measurement of fluid weight gain between dialysis sessions; Will be measured in both groups at baseline and after 6 months. | Baseline & 6 months | 
| Body Mass Index (BMI) | 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. | Baseline & 6 months | 
| Triceps Skinfold Thickness | 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. | Baseline & 6 months | 
| Mid Arm (Muscle) Circumference | 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. | Baseline & 6 months | 
| Handgrip Strength | 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. | Baseline & 6 months | 
| Bio-electrical Impedance | 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. | Baseline & 6 months | 
| Serum Albumin | Serum albumin will be measured as part of hemodialysis standard of care. Change in baseline serum albumin will be evaluated at 6 months. | Baseline & 6 months | 
| C-reactive protein (CRP) | C-reactive protein will be measured as part of hemodialysis standard of care. Change in baseline CRP will be evaluated at 6 months. | Baseline & 6 months | 
| Total iron binding capacity (TIBC) | 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. | Baseline & 6 months | 
| Phosphate Binders | Changes in use and number/dose of phosphate binders will be measured at baseline and after 6 months in both groups. | Baseline & 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemodialysis, nutritional status