Clinical trial NCT02887391: Comparing Nutritional Status of In-centre Nocturnal Hemodialysis Patients to Conventional Hemodialysis Patients
Official title: Comparing Nutritional Status of In-centre Nocturnal Hemodialysis Patients to Conventional Hemodialysis Patients: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: End Stage Renal Failure on Dialysis
Keywords: hemodialysis
nutritional status
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2016-09-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Malnutrition Inflammation Score (MIS)
timeFrame: Baseline & 6 months
Secondary outcomes:
measure: Quality of Life
timeFrame: Baseline & 6 months
measure: Dietary Intake
timeFrame: Baseline & 6 months
measure: Appetite
timeFrame: Baseline & 6 months
measure: Interdialytic Weight Gain
timeFrame: Baseline & 6 months
measure: Body Mass Index (BMI)
timeFrame: Baseline & 6 months
measure: Triceps Skinfold Thickness
timeFrame: Baseline & 6 months
measure: Mid Arm (Muscle) Circumference
timeFrame: Baseline & 6 months
measure: Handgrip Strength
timeFrame: Baseline & 6 months
measure: Bio-electrical Impedance
timeFrame: Baseline & 6 months
measure: Serum Albumin
timeFrame: Baseline & 6 months
measure: C-reactive protein (CRP)
timeFrame: Baseline & 6 months
measure: Total iron binding capacity (TIBC)
timeFrame: Baseline & 6 months
measure: Phosphate Binders
timeFrame: Baseline & 6 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Health Services Southern Alberta Renal Program
state: Alberta
Study officials:
affiliation: University of Calgary
name: Jennifer MacRae, MSc, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: Tanis Fenton, PhD, RD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: Rebecca Holmes, BCom, BSc
role: STUDY_DIRECTOR
References:
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citation: 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.
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citation: 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.
citation: 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.
citation: 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.
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citation: 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.