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

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ClinicalTrials.gov Identifier: NCT02887391
Recruitment Status : Unknown
Verified August 2016 by Dr Jennifer MacRae, University of Calgary.
Recruitment status was:  Enrolling by invitation
First Posted : September 2, 2016
Last Update Posted : September 2, 2016
Sponsor:
Information provided by (Responsible Party):
Dr Jennifer MacRae, University of Calgary

Study Description
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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.

Condition or disease Intervention/treatment
End Stage Renal Failure on Dialysis Other: No intervention - observational study

Study Design
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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparing Nutritional Status of In-centre Nocturnal Hemodialysis Patients to Conventional Hemodialysis Patients: A Prospective Cohort Study
Study Start Date : January 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Groups and Cohorts
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Group/Cohort Intervention/treatment
Conventional Hemodialysis
Control group 4 hours of hemodialysis 3x per week (12 hours hemodialysis/week)
 Other: No intervention - observational study
No intervention - observational study
In-Centre Nocturnal Hemodialysis
8 hours of hemodialysis 3x per week (24 hours hemodialysis/week)
 Other: No intervention - observational study
No intervention - observational study


Outcome Measures
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Primary Outcome Measures :
  1. Malnutrition Inflammation Score (MIS) [ Time Frame: 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 :
  1. Quality of Life [ Time Frame: 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.

  2. Dietary Intake [ Time Frame: 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.

  3. Appetite [ Time Frame: 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.

  4. Interdialytic Weight Gain [ Time Frame: Baseline & 6 months ]
    Measurement of fluid weight gain between dialysis sessions; Will be measured in both groups at baseline and after 6 months.

  5. Body Mass Index (BMI) [ Time Frame: 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.

  6. Triceps Skinfold Thickness [ Time Frame: 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.

  7. Mid Arm (Muscle) Circumference [ Time Frame: 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.

  8. Handgrip Strength [ Time Frame: 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.

  9. Bio-electrical Impedance [ Time Frame: 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.

  10. Serum Albumin [ Time Frame: 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.

  11. C-reactive protein (CRP) [ Time Frame: 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.

  12. Total iron binding capacity (TIBC) [ Time Frame: 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.

  13. Phosphate Binders [ Time Frame: Baseline & 6 months ]
    Changes in use and number/dose of phosphate binders will be measured at baseline and after 6 months in both groups.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02887391


Locations
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Canada, Alberta
Alberta Health Services Southern Alberta Renal Program
Calgary, Alberta, Canada, T2N 2T9
Sponsors and Collaborators
University of Calgary
Investigators
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Principal Investigator: Jennifer MacRae, MSc, MD University of Calgary
Principal Investigator: Tanis Fenton, PhD, RD University of Calgary
Study Director: Rebecca Holmes, BCom, BSc University of Calgary
More Information
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Publications:

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Responsible Party: Dr Jennifer MacRae, Associate Professor Medicine, University of Calgary
ClinicalTrials.gov Identifier: NCT02887391    
Other Study ID Numbers: E-2358
First Posted: September 2, 2016    Key Record Dates
Last Update Posted: September 2, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Individual participant data will not be shared
Keywords provided by Dr Jennifer MacRae, University of Calgary:
hemodialysis
nutritional status
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic