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

August 29, 2016 updated by: Dr Jennifer MacRae, University of Calgary

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Alberta Health Services Southern Alberta Renal Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline & 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline & 6 months
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.
Baseline & 6 months
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.
Baseline & 6 months
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.
Baseline & 6 months
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.
Baseline & 6 months
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.
Baseline & 6 months
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.
Baseline & 6 months
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.
Baseline & 6 months
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.
Baseline & 6 months
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.
Baseline & 6 months
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.
Baseline & 6 months
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.
Baseline & 6 months
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.
Baseline & 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

August 15, 2016

First Submitted That Met QC Criteria

August 29, 2016

First Posted (Estimate)

September 2, 2016

Study Record Updates

Last Update Posted (Estimate)

September 2, 2016

Last Update Submitted That Met QC Criteria

August 29, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-2358

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Individual participant data will not be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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