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

NCT ID: NCT02887391

Last Updated: 2016-09-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-06-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Conventional Hemodialysis

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

No intervention - observational study

Intervention Type: OTHER

No intervention - observational study

In-Centre Nocturnal Hemodialysis

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

No intervention - observational study

Intervention Type: OTHER

No intervention - observational study

Interventions

No intervention - observational study

No intervention - observational study

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Dr Jennifer MacRae

Associate Professor Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer MacRae, MSc, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Tanis Fenton, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Rebecca Holmes, BCom, BSc

Role: STUDY_DIRECTOR

University of Calgary

Locations

Alberta Health Services Southern Alberta Renal Program

Calgary, Alberta, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 22362905 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19965529 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23735837 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23698226 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25074839 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7579073 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11728958 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15069177 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26034747 (View on PubMed)

Other Identifiers

E-2358

Identifier Type: -

Identifier Source: org_study_id