Removal of Uremic Toxins With Nocturnal Dialysis Versus Standard Dialysis
Primary Purpose
Chronic Renal Failure
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Nocturnal dialysis
Standard dialysis
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Renal Failure
Eligibility Criteria
Inclusion Criteria:
- age > 18 years
Exclusion Criteria:
- pregnancy
Sites / Locations
- University Hospital Ghent
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Nocturnal dialysis
Standard dialysis
Outcomes
Primary Outcome Measures
To evaluate what is more effective for removal of uremic toxins - nocturnal versus standard dialysis?
Secondary Outcome Measures
Full Information
NCT ID
NCT00766792
First Posted
October 3, 2008
Last Updated
October 30, 2008
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT00766792
Brief Title
Removal of Uremic Toxins With Nocturnal Dialysis Versus Standard Dialysis
Official Title
Removal of Uremic Toxins With Nocturnal Dialysis Versus Standard Dialysis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Dialysis patients, who decide to switch from standard dialysis (3 times 240-270 min/week) to nocturnal dialysis (3 times 480 min/week), will be followed. In parallel a control group with patients staying on standard dialysis will be followed. The study will last 30 weeks. During this period blood samples (pre- and post-dialysis: 10 times; inlet and outlet of dialyzer: 3 times) will be collected on predetermined time points. Concentration of several uremic retention solutes will be determined.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Nocturnal dialysis
Arm Title
2
Arm Type
Active Comparator
Arm Description
Standard dialysis
Intervention Type
Procedure
Intervention Name(s)
Nocturnal dialysis
Intervention Description
Switch to nocturnal dialysis (3 times 480 min/week)
Intervention Type
Procedure
Intervention Name(s)
Standard dialysis
Intervention Description
Standard dialysis (3 times 240-270 min/week)
Primary Outcome Measure Information:
Title
To evaluate what is more effective for removal of uremic toxins - nocturnal versus standard dialysis?
Time Frame
30 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age > 18 years
Exclusion Criteria:
pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Vanholder, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
Website of the University Hospital Ghent
Learn more about this trial
Removal of Uremic Toxins With Nocturnal Dialysis Versus Standard Dialysis
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