An observational study in End Stage Renal Failure on Dialysis, sponsored by University of Calgary. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-02.
Sponsored by University of Calgary · Observational
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.
2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.
This study's planned enrollment of 20 is below the median of 120 across 431 observational studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →University of Calgary is the lead sponsor of 686 studies on the registry; 189 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult patients at all hemodialysis (HD) sites in the Southern Alberta Renal Program may be included. These sites include: Foothills Medical Center HD, Northland HD, Fanning HD, Sheldon Chumir HD, South Calgary HD, Peter Lougheed HD, and Sunridge HD in Calgary, AB.
Exclusion Criteria:
Control group 4 hours of hemodialysis 3x per week (12 hours hemodialysis/week)
Other: No intervention - observational study
8 hours of hemodialysis 3x per week (24 hours hemodialysis/week)
Other: No intervention - observational study
No intervention - observational study
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.
Time frame: Baseline & 6 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline & 6 months
Plan to share: Undecided — Individual participant data will not be shared
This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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University of Calgary