Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00417105
Registration number
NCT00417105
Ethics application status
Date submitted
28/12/2006
Date registered
29/12/2006
Date last updated
5/03/2009
Titles & IDs
Public title
Protein-Bound Uremic Retention Solutes in Long Nocturnal Hemodialysis
Query!
Scientific title
A Multicentric Observational Study on the Removal of Protein-Bound Uremic Retention Solutes in Nocturnal Hemodialysis: A Cross-Sectional Analysis
Query!
Secondary ID [1]
0
0
NHD001
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
End Stage Renal Disease
0
0
Query!
Condition category
Condition code
Renal and Urogenital
0
0
0
0
Query!
Kidney disease
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
Description of intervention(s) / exposure
Treatment: Surgery - hemodialysis
Treatment: Surgery - hemodialysis
Treatment: Surgery - hemodialysis
Treatment: Surgery - hemodialysis
1 - hemodialysis twice weekly 4 hours
2 - nocturnal dialysis twice weekly 8 hours
3 - nocturnal hemodialysis, 8 hours every other night
4 - nocturnal hemodialysis, 8 hours, six times per week
Treatment: Surgery: hemodialysis
group 1: twice weekly, four hours
Treatment: Surgery: hemodialysis
group 2: twice weekly, eight hours
Treatment: Surgery: hemodialysis
group 3: every other day, eight hours
Treatment: Surgery: hemodialysis
group 4: six days a week, eight hours
Query!
Intervention code [1]
0
0
Treatment: Surgery
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
removal of protein-bound retention solutes
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
1 dialysis session
Query!
Eligibility
Key inclusion criteria
- Age > 18 years
- Maintenance hemodialysis (> 3 months duration)
- Informed consent
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- No consent
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/12/2006
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/12/2008
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
120
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
0
0
Monash Medical Centre - Clayton
Query!
Recruitment hospital [2]
0
0
Geelong Hospital - Geelong
Query!
Recruitment postcode(s) [1]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [2]
0
0
3220 - Geelong
Query!
Recruitment outside Australia
Country [1]
0
0
Belgium
Query!
State/province [1]
0
0
Limburg
Query!
Country [2]
0
0
Belgium
Query!
State/province [2]
0
0
Vlaams-Brabant
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Universitaire Ziekenhuizen KU Leuven
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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. ß2-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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00417105
Query!
Trial related presentations / publications
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.
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.
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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Björn KI Meijers, MD
Query!
Address
0
0
Universitaire Ziekenhuizen KU Leuven
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00417105
Download to PDF