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

End Stage Renal Failure on Dialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02887391
• Other study ID #: E-2358
• Status: Enrolling by invitation
• Phase: N/A
• First received: August 15, 2016
• Last updated: August 29, 2016
• Start date: January 2016
• Est. completion date: June 2017

Study information

• Verified date: August 2016
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• End Stage Renal Failure on Dialysis
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Other:
• No intervention - observational study
No intervention - observational study

Locations

Country	Name	City	State
Canada	Alberta Health Services Southern Alberta Renal Program	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. Review. — View Citation

Isoyama N, Qureshi AR, Avesani CM, Lindholm B, Bàràny P, Heimbürger 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. — View 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. — View Citation

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. Epub 2004 Apr 6. — View 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. — View Citation

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	Baseline & 6 months	No
Secondary	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.	Baseline & 6 months	No
Secondary	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.	Baseline & 6 months	No
Secondary	Interdialytic Weight Gain	Measurement of fluid weight gain between dialysis sessions; Will be measured in both groups at baseline and after 6 months.	Baseline & 6 months	No
Secondary	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.	Baseline & 6 months	No
Secondary	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.	Baseline & 6 months	No
Secondary	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.	Baseline & 6 months	No
Secondary	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.	Baseline & 6 months	No
Secondary	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.	Baseline & 6 months	No
Secondary	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.	Baseline & 6 months	No
Secondary	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.	Baseline & 6 months	No
Secondary	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.	Baseline & 6 months	No
Secondary	Phosphate Binders	Changes in use and number/dose of phosphate binders will be measured at baseline and after 6 months in both groups.	Baseline & 6 months	No