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

NCT02887391 | Unknown

• 1 other identifier: E-2358
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Failure on Dialysis

Keywords

hemodialysis; nutritional status

Outcome Measures

Primary Outcomes (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.

  Baseline & 6 months

Secondary Outcomes (13)

• Quality of Life

  Baseline & 6 months

• Dietary Intake

  Baseline & 6 months

• Appetite

  Baseline & 6 months

• Interdialytic Weight Gain

  Baseline & 6 months

• Body Mass Index (BMI)

  Baseline & 6 months

Study Arms (2)

Conventional Hemodialysis

Control group 4 hours of hemodialysis 3x per week (12 hours hemodialysis/week)

Other: No intervention - observational study

In-Centre Nocturnal Hemodialysis

8 hours of hemodialysis 3x per week (24 hours hemodialysis/week)

Other: No intervention - observational study

Interventions

No intervention - observational study OTHER

No intervention - observational study

Conventional Hemodialysis; In-Centre Nocturnal Hemodialysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Alberta Health Services Southern Alberta Renal Program

Calgary, Alberta, T2N 2T9, Canada

Location

Related Publications (9)

• 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.

  PMID: 22362905 BACKGROUND

• 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.

  PMID: 19965529 BACKGROUND

• 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.

  PMID: 23735837 BACKGROUND

• 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.

  PMID: 23698226 BACKGROUND

• 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.

  PMID: 25074839 BACKGROUND

• 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.

  PMID: 7579073 BACKGROUND

• 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.

  PMID: 11728958 BACKGROUND

• 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.

  PMID: 15069177 BACKGROUND

• 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.

  PMID: 26034747 BACKGROUND

Study Officials

• Jennifer MacRae, MSc, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

• Tanis Fenton, PhD, RD

  University of Calgary

  PRINCIPAL INVESTIGATOR

• Rebecca Holmes, BCom, BSc

  University of Calgary

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Medicine

Study Record Dates

• First Submitted: August 15, 2016
• First Posted: September 2, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: September 2, 2016

Record last verified: 2016-08

Locations

CA (1)