Protein-bound Uremic Retention Solutes and Long Nocturnal Hemodialysis: a Longitudinal Analysis

Sponsor

Universitaire Ziekenhuizen Leuven (Other)

Overall Status

Completed

CT.gov ID

NCT00417339

Collaborator

(none)

Enrollment

Locations

Duration (Months)

9.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Study on intradialytic kinetics of protein-bound uremic retention solutes during long nocturnal hemodialysis

Condition or Disease	Intervention/Treatment	Phase
End Stage Kidney Disease	Procedure: hemodialysis

Detailed Description

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. A 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 (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.

Study Design

Study Type:

Observational

Actual Enrollment :

38 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Multicentric Observational Trial on Protein Bound Uremic Toxins in Nocturnal Hemodialysis

Study Start Date :

Dec 1, 2006

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
hemodialysis, 4h, twice weekly hemodialysis, four hours, twice weekly	Procedure: hemodialysis individualised
hemodialysis, 8h, twice weekly hemodialysis, eight hours, twice weekly	Procedure: hemodialysis individualised
hemodialysis, 8h, every other day hemodialysis, eight hours, every other day	Procedure: hemodialysis individualised
hemodialysis, 8h, six days per week hemodialysis, eight hours, six days per week	Procedure: hemodialysis individualised

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Start hemodialysis during 2007
Age over 18 years
Informed consent

Exclusion Criteria:

Non consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Monash Medical Centre	Clayton	Victoria	Australia	3168
2	Geelong Hospital	Geelong	Victoria	Australia	3220
3	Universitaire Ziekenhuizen Leuven	Leuven	Brabant	Belgium	3000
4	Virga Jesseziekenhuis	Hasselt	Limburg	Belgium	3500