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End Stage Renal Failure on DialysisNCT02887391

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

An observational study of End Stage Renal Failure on Dialysis, run by University of Calgary at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
End Stage Renal Failure on Dialysis
How many people
20 participants
Where
1 siteCanada
Study dates
Jan 2016to Jun 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • >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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Alberta Health Services Southern Alberta Renal Program

    Calgary, Alberta, T2N 2T9

Other trials in Canada

About this study

Official title: 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.

Being tested
No intervention - observational study
Keywords
hemodialysis, nutritional status

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No intervention - observational studyOther

    No intervention - observational study

Study groups in NCT02887391
Study groupRoleWhat they receive
Conventional HemodialysisControl group 4 hours of hemodialysis 3x per week (12 hours hemodialysis/week)
Receives: Other: No intervention - observational study
In-Centre Nocturnal Hemodialysis8 hours of hemodialysis 3x per week (24 hours hemodialysis/week)
Receives: Other: No intervention - observational study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline & 6 months

Secondary outcomes (13)

  1. 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.

    Measured: Baseline & 6 months

  2. 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.

    Measured: Baseline & 6 months

  3. 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.

    Measured: Baseline & 6 months

  4. Interdialytic Weight Gain

    Measurement of fluid weight gain between dialysis sessions; Will be measured in both groups at baseline and after 6 months.

    Measured: Baseline & 6 months

  5. 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.

    Measured: Baseline & 6 months

  6. 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.

    Measured: Baseline & 6 months

  7. 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.

    Measured: Baseline & 6 months

  8. 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.

    Measured: Baseline & 6 months

  9. 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.

    Measured: Baseline & 6 months

  10. 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.

    Measured: Baseline & 6 months

  11. 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.

    Measured: Baseline & 6 months

  12. 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.

    Measured: Baseline & 6 months

  13. Phosphate Binders

    Changes in use and number/dose of phosphate binders will be measured at baseline and after 6 months in both groups.

    Measured: Baseline & 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionJun 2017 (estimated)
  4. Study completionJun 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02887391
Sponsor's protocol ID
E-2358
Status last verified
Aug 2016
First submitted
15 Aug 2016
Last updated
2 Sep 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided: Individual participant data will not be shared

Publications

  • Lacson E Jr, Xu J, Suri RS, Nesrallah G, Lindsay R, Garg AX, Lester K, Ofsthun N, Lazarus M, Hakim RM. Survival with three-times weekly in-center nocturnal versus conventional hemodialysis. J Am Soc Nephrol. 2012 Apr;23(4):687-95. doi: 10.1681/ASN.2011070674. Epub 2012 Feb 23.

    PubMed 22362905

  • Lacson E Jr, Wang W, Lester K, Ofsthun N, Lazarus JM, Hakim RM. Outcomes associated with in-center nocturnal hemodialysis from a large multicenter program. Clin J Am Soc Nephrol. 2010 Feb;5(2):220-6. doi: 10.2215/CJN.06070809. Epub 2009 Dec 3.

    PubMed 19965529

  • Demirci C, Ozkahya M, Demirci MS, Asci G, Kose T, Colak T, Duman S, Toz H, Ergin P, Adam SM, Ok E. Effects of three times weekly eight-hour nocturnal hemodialysis on volume and nutritional status. Am J Nephrol. 2013;37(6):559-67. doi: 10.1159/000351182. Epub 2013 May 30.

    PubMed 23735837

  • Ikizler TA, Cano NJ, Franch H, Fouque D, Himmelfarb J, Kalantar-Zadeh K, Kuhlmann MK, Stenvinkel P, TerWee P, Teta D, Wang AY, Wanner C; International Society of Renal Nutrition and Metabolism. Prevention and treatment of protein energy wasting in chronic kidney disease patients: a consensus statement by the International Society of Renal Nutrition and Metabolism. Kidney Int. 2013 Dec;84(6):1096-107. doi: 10.1038/ki.2013.147. Epub 2013 May 22.

    PubMed 23698226

  • Isoyama N, Qureshi AR, Avesani CM, Lindholm B, Barany P, Heimburger O, Cederholm T, Stenvinkel P, Carrero JJ. Comparative associations of muscle mass and muscle strength with mortality in dialysis patients. Clin J Am Soc Nephrol. 2014 Oct 7;9(10):1720-8. doi: 10.2215/CJN.10261013. Epub 2014 Jul 29.

    PubMed 25074839

  • Chertow GM, Lowrie EG, Wilmore DW, Gonzalez J, Lew NL, Ling J, Leboff MS, Gottlieb MN, Huang W, Zebrowski B, et al. Nutritional assessment with bioelectrical impedance analysis in maintenance hemodialysis patients. J Am Soc Nephrol. 1995 Jul;6(1):75-81. doi: 10.1681/ASN.V6175.

    PubMed 7579073

  • Kalantar-Zadeh K, Kopple JD, Block G, Humphreys MH. A malnutrition-inflammation score is correlated with morbidity and mortality in maintenance hemodialysis patients. Am J Kidney Dis. 2001 Dec;38(6):1251-63. doi: 10.1053/ajkd.2001.29222.

    PubMed 11728958

  • Kalantar-Zadeh K, Kopple JD, Humphreys MH, Block G. Comparing outcome predictability of markers of malnutrition-inflammation complex syndrome in haemodialysis patients. Nephrol Dial Transplant. 2004 Jun;19(6):1507-19. doi: 10.1093/ndt/gfh143. Epub 2004 Apr 6.

    PubMed 15069177

  • Sohrabi Z, Eftekhari MH, Eskandari MH, Rezaeianzadeh A, Sagheb MM. Malnutrition-inflammation score and quality of life in hemodialysis patients: is there any correlation? Nephrourol Mon. 2015 May 23;7(3):e27445. doi: 10.5812/numonthly.7(3)2015.27445. eCollection 2015 May.

    PubMed 26034747

Questions about this trial

What is this clinical trial studying?

An observational study of End Stage Renal Failure on Dialysis, run by University of Calgary at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Malnutrition Inflammation Score (MIS) (time frame: Baseline & 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02887391, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2016.

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