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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Calgary

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 2, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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