CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 120 enrolled
Drug / intervention
hemodialysis +3 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00417105
NCT00417105N/ACompleted

A Multicentric Observational Study on the Removal of Protein-Bound Uremic Retention Solutes in Nocturnal Hemodialysis: A Cross-Sectional Analysis

Universitaire Ziekenhuizen KU Leuven·observational·Posted Dec 29, 2006·Updated Mar 5, 2009

In Brief

An observational study evaluating hemodialysis for End Stage Renal Disease. Completed, enrolled 120 participants across 4 sites in 2 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Belgium
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 29, 2006
Enrollment StartDec 1, 2006
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 19.5 years ago

Interventions

hemodialysisprocedure

group 1: twice weekly, four hours

hemodialysisprocedure

group 2: twice weekly, eight hours

hemodialysisprocedure

group 3: every other day, eight hours

hemodialysisprocedure

group 4: six days a week, eight hours