Protein-Bound Uremic Retention Solutes in Long Nocturnal Hemodialysis

NCT ID: NCT00417105

Last Updated: 2009-03-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2008-12-31

Brief Summary

Although remarkable progress has been made, chronic kidney disease still poses a major burden on both individual patients, as well as on society as a whole. There is a strong inverse relationship between decreasing renal function, as estimated by glomerular filtration rate, and mortality rate, especially death due to cardiovascular disease. The exact cause(s) remain to be elucidated. Uremic toxins might play an important role.

In the course of decreasing renal function the concentration of numerous intracellular and extracellular compounds vary from the non-uremic state. But still increasing number of uremic retention solutes are being identified. Renal replacement strategies aim to remove potentially harmful substances from the body. Traditionally much attention has been paid to small water-soluble molecules such as urea nitrogen and creatinine. Based on the results of the recent HEMO and ADEMEX studies, increases of small water-soluble solute removal above the level reached with modern dialysis techniques - hemodialysis, peritoneal dialysis (HD, PD) - seem not to be advantageous with regard to patient outcome. These findings may point to the importance of other distinct groups of uremic retention solutes. In view of the data described above, protein-bound solutes might be good candidates.

Several advantages of long duration hemodialysis have been observed, including a better control of blood pressure by decreasing extracellular fluid volume, lowering peripheral vascular resistance and improving endothelium-dependent and -independent vasodilation. A normalization of heart rate variability and improvement of left-ventricular function was noted as well. Furthermore, anemia control has been shown to be easier and several nutritional parameters improved in patients treated with long duration HD. The therapy results in higher small water-soluble solute removal, phosphate removal and greater elimination of larger molecules (e.g. β2-microglobulin).

It seems an appealing question whether a better control of the serum levels of protein-bound solutes can be achieved by long duration (nocturnal) hemodialysis. This might be another advantage of this therapeutic modality, or may even in part explain the better outcome of patients treated this way.

The study compares intermittent hemodialysis with long nocturnal hemodialysis with respect to serum concentrations of several protein bound uremic toxins, as well as solute removal.

Conditions

End Stage Renal Disease

Study Design

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

Study Groups

1

hemodialysis twice weekly 4 hours

hemodialysis

Intervention Type: PROCEDURE

group 1: twice weekly, four hours

2

nocturnal dialysis twice weekly 8 hours

hemodialysis

Intervention Type: PROCEDURE

group 2: twice weekly, eight hours

3

nocturnal hemodialysis, 8 hours every other night

hemodialysis

Intervention Type: PROCEDURE

group 3: every other day, eight hours

4

nocturnal hemodialysis, 8 hours, six times per week

hemodialysis

Intervention Type: PROCEDURE

group 4: six days a week, eight hours

Interventions

hemodialysis

group 1: twice weekly, four hours

Intervention Type: PROCEDURE

hemodialysis

group 2: twice weekly, eight hours

Intervention Type: PROCEDURE

hemodialysis

group 3: every other day, eight hours

Intervention Type: PROCEDURE

hemodialysis

group 4: six days a week, eight hours

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age > 18 years
• Maintenance hemodialysis (> 3 months duration)
• Informed consent

Exclusion Criteria

• No consent

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

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

University Hospitals Leuven

Principal Investigators

Björn KI Meijers, MD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Pieter Evenepoel, MD, PhD

Role: STUDY_DIRECTOR

Universitaire Ziekenhuizen KU Leuven

Tom Dejagere, MD

Role: PRINCIPAL_INVESTIGATOR

Virga Jesse Ziekenhuis

Nigel Toussaint, MD

Role: PRINCIPAL_INVESTIGATOR

Geelong Hospital

Locations

Monash Medical Centre

Clayton, Victoria, Australia

Geelong Hospital

Geelong, Victoria, Australia

Virga Jesse Ziekenhuis

Hasselt, Limburg, Belgium

Universitaire Ziekenhuizen Leuven

Leuven, Vlaams-Brabant, Belgium

Countries

Australia; Belgium

References

Bammens B, Evenepoel P, Keuleers H, Verbeke K, Vanrenterghem Y. Free serum concentrations of the protein-bound retention solute p-cresol predict mortality in hemodialysis patients. Kidney Int. 2006 Mar;69(6):1081-7. doi: 10.1038/sj.ki.5000115.

Reference Type: BACKGROUND

PMID: 16421516 (View on PubMed)

Fagugli RM, De Smet R, Buoncristiani U, Lameire N, Vanholder R. Behavior of non-protein-bound and protein-bound uremic solutes during daily hemodialysis. Am J Kidney Dis. 2002 Aug;40(2):339-47. doi: 10.1053/ajkd.2002.34518.

Reference Type: BACKGROUND

PMID: 12148107 (View on PubMed)

Pierratos A. Daily nocturnal home hemodialysis. Kidney Int. 2004 May;65(5):1975-86. doi: 10.1111/j.1523-1755.2004.00603.x. No abstract available.

Reference Type: BACKGROUND

PMID: 15086951 (View on PubMed)

Other Identifiers

NHD001

Identifier Type: -

Identifier Source: org_study_id