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Removal of Uremic Toxins With Nocturnal Dialysis Versus Standard Dialysis

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00766792
Recruitment Status : Completed
First Posted : October 6, 2008
Last Update Posted : October 31, 2008
Sponsor:
Information provided by:
University Hospital, Ghent

Tracking Information
First Submitted Date  ICMJE October 3, 2008
First Posted Date  ICMJE October 6, 2008
Last Update Posted Date October 31, 2008
Study Start Date  ICMJE December 2005
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2008)
To evaluate what is more effective for removal of uremic toxins - nocturnal versus standard dialysis? [ Time Frame: 30 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 3, 2008)
To evaluate what is more effective for removal of uremic toxins - nocturnal versus standard dialysis? [ Time Frame: 3 months ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Removal of Uremic Toxins With Nocturnal Dialysis Versus Standard Dialysis
Official Title  ICMJE Removal of Uremic Toxins With Nocturnal Dialysis Versus Standard Dialysis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Renal Failure
Intervention  ICMJE
  • Procedure: Nocturnal dialysis
    Switch to nocturnal dialysis (3 times 480 min/week)
  • Procedure: Standard dialysis
    Standard dialysis (3 times 240-270 min/week)
Study Arms  ICMJE
  • Experimental: 1
    Nocturnal dialysis
    Intervention: Procedure: Nocturnal dialysis
  • Active Comparator: 2
    Standard dialysis
    Intervention: Procedure: Standard dialysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 3, 2008)
15
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • age > 18 years

Exclusion Criteria:

  • pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00766792
Other Study ID Numbers  ICMJE 2005/288
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Raymond Vanholder, University Hospital Ghent
Study Sponsor  ICMJE University Hospital, Ghent
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Raymond Vanholder, MD, PhD University Hospital, Ghent
PRS Account University Hospital, Ghent
Verification Date October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP