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More Frequent Dialysis (>3 Treatments Per Week) (MFD)

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ClinicalTrials.gov Identifier: NCT00575497
Recruitment Status : Unknown
Verified December 2007 by Satellite Healthcare.
Recruitment status was:  Recruiting
First Posted : December 18, 2007
Last Update Posted : December 18, 2007
Sponsor:
Information provided by:

December 14, 2007
December 18, 2007
December 18, 2007
January 2005
Not Provided
Hospitalization days per year [ Time Frame: Ongoing ]
Same as current
No Changes Posted
  • Nutritional Status measured by Subjective Global Assessment [ Time Frame: Ongoing ]
  • Anemia, measured by erythropoetin dose [ Time Frame: Ongoing ]
  • Control of hypertension, as measured by number of antihypertensive tablets taken per day [ Time Frame: Ongoing ]
  • Control of hyperphosphatemia, as measured by number of phosphate binder tablets taken per day [ Time Frame: Ongoing ]
Same as current
Not Provided
Not Provided
 
More Frequent Dialysis (>3 Treatments Per Week)
Study of Clinical Outcomes of More Frequent Hemodialysis
The study compares the benefits of short daily hemodialysis six days a week, nocturnal (night time) hemodialysis six days a week, every other day and every other night hemodialysis to traditional three days a week hemodialysis.The hypothesis is that increasing hemodialysis treatment time and/or frequency will improve outcomes.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • End Stage Renal Disease
  • Chronic Kidney Disease
  • Procedure: More frequent hemodialysis
    Six Day per week short daily hemodialysis
  • Procedure: More frequent hemodialysis
    Six nights per week nocturnal hemodialysis
  • Procedure: More frequent hemodialysis
    Every other day short daily hemodialysis
  • Procedure: More frequent hemodialysis
    Every other night hemodialysis
  • Procedure: More frequent hemodialysis
    5 days per week short daily hemodialysis
  • Procedure: More frequent hemodialysis
    5 nights per week hemodialysis
  • Procedure: Conventional Hemodialysis
    3 days per week short daily hemodialysis
  • Experimental: A
    Six Day per week short daily hemodialysis
    Intervention: Procedure: More frequent hemodialysis
  • Experimental: B
    Six nights per week nocturnal hemodialysis
    Intervention: Procedure: More frequent hemodialysis
  • Experimental: C
    Every other day short daily hemodialysis
    Intervention: Procedure: More frequent hemodialysis
  • Experimental: D
    Every other night hemodialysis
    Intervention: Procedure: More frequent hemodialysis
  • Experimental: E
    5 days per week short daily hemodialysis
    Intervention: Procedure: More frequent hemodialysis
  • Experimental: F
    5 nights per week hemodialysis
    Intervention: Procedure: More frequent hemodialysis
  • Active Comparator: G
    Conventional three time per week short daily hemodialysis
    Intervention: Procedure: Conventional Hemodialysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
300
January 2010
Not Provided

Inclusion Criteria:

  • Stable vascular access, i.e., lack of needling difficulties and stable flow rates. Accesses will include fistulae, grafts, catheters and ports.
  • 18 years of age.
  • History of compliance with a dialysis treatment schedule, or if a new patient, express a willingness to be compliant with a treatment schedule.
  • Plan to continue care and follow-up at the investigational site.
  • Able to sign the informed consent and other relevant documents.

Exclusion Criteria:

  • History of poor compliance with thrice (or twice) weekly dialysis schedules as manifested by more than three unexplained missed treatments in the past six (6) months.
  • Pregnancy.
  • Intravenous drug abuser.
  • Expects to receive a transplant or transfer to another facility within six months of entering the study.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00575497
SR002MFD
No
Not Provided
Not Provided
Brigitte Schiller-Moran MD, Satellite Healthcare, Inc.
Satellite Healthcare
Not Provided
Study Director: John Moran, MD Satellite Healthcare, Inc.
Principal Investigator: Brigittte Schiller-Moran, MD Satellite Healthcare, Inc.
Satellite Healthcare
December 2007

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