Protein-Bound Uremic Retention Solutes in Long Nocturnal Hemodialysis

NCT00417105 | Completed DMC

• 1 other identifier: NHD001
• Study Type: observational
• Target: 120
• Locations: 2 countries
• Sites: 4

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

Keywords

hemodialysis; dialysis adequacy; chronic kidney disease

Outcome Measures

Primary Outcomes (1)

• removal of protein-bound retention solutes

  1 dialysis session

Study Arms (4)

1

hemodialysis twice weekly 4 hours

Procedure: hemodialysis

2

nocturnal dialysis twice weekly 8 hours

Procedure: hemodialysis

3

nocturnal hemodialysis, 8 hours every other night

Procedure: hemodialysis

4

nocturnal hemodialysis, 8 hours, six times per week

Procedure: hemodialysis

Interventions

hemodialysis PROCEDURE

group 1: twice weekly, four hours

1

Eligibility Criteria

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

Study Population

Maintenance hemodialysis patients

You may qualify if:

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

You may not qualify if:

• No consent

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (4)

Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

Geelong Hospital

Geelong, Victoria, 3220, Australia

Location

Virga Jesse Ziekenhuis

Hasselt, Limburg, 3500, Belgium

Location

Universitaire Ziekenhuizen Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Related Publications (3)

• 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.

  PMID: 16421516 BACKGROUND

• 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.

  PMID: 12148107 BACKGROUND

• 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.

  PMID: 15086951 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, urine, dialysate

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency, Chronic

Interventions

Renal Dialysis

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Sorption Detoxification

Study Officials

• Björn KI Meijers, MD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

• Pieter Evenepoel, MD, PhD

  Universitaire Ziekenhuizen KU Leuven

  STUDY DIRECTOR

• Tom Dejagere, MD

  Virga Jesse Ziekenhuis

  PRINCIPAL INVESTIGATOR

• Nigel Toussaint, MD

  Geelong Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 28, 2006
• First Posted: December 29, 2006
• Study Start: December 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 5, 2009

Record last verified: 2009-03

Locations

BE (2); AU (2)