Short Daily Hemodialysis and Online HDF: Which One is Better? (SHD)
Primary Purpose
End Stage Renal Disease
Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Online HDF
Short Daily Hemodialysis
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease
Eligibility Criteria
Inclusion Criteria:
- stable ESRD
- KT/V > 1.2 for thrice weekly or > 1.8 for twice weekly
Exclusion Criteria:
- Inadequate vascular access flow rate
- Concurrent medical illnesses
- History of non-compliance
Sites / Locations
- Renal Unit, BMA Medical College and Vajira Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Online HDF
Short Daily Hemodialysis
Arm Description
Online HDF
Short Daily Hemodialysis
Outcomes
Primary Outcome Measures
Adequacy
Secondary Outcome Measures
Hematocrit, calcium, phosphorus
Full Information
NCT ID
NCT00939445
First Posted
July 14, 2009
Last Updated
December 13, 2015
Sponsor
Bangkok Metropolitan Administration Medical College and Vajira Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00939445
Brief Title
Short Daily Hemodialysis and Online HDF: Which One is Better?
Acronym
SHD
Official Title
Short Daily Hemodialysis and Online HDF: Which One is Better?
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bangkok Metropolitan Administration Medical College and Vajira Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
1. To compare the efficacy of
Short Daily Hemodialysis
Online HDF in term of adequacy of dialysis.
Detailed Description
The investigators intend to compare the efficacy between these modalities of treatment in terms of adequacy and also other parameters such as calcium-phosphorus balance and hematocrit
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Online HDF
Arm Type
Active Comparator
Arm Description
Online HDF
Arm Title
Short Daily Hemodialysis
Arm Type
Active Comparator
Arm Description
Short Daily Hemodialysis
Intervention Type
Procedure
Intervention Name(s)
Online HDF
Intervention Description
Online HDF
Intervention Type
Procedure
Intervention Name(s)
Short Daily Hemodialysis
Intervention Description
Short Daily Hemodialysis
Primary Outcome Measure Information:
Title
Adequacy
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Hematocrit, calcium, phosphorus
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
stable ESRD
KT/V > 1.2 for thrice weekly or > 1.8 for twice weekly
Exclusion Criteria:
Inadequate vascular access flow rate
Concurrent medical illnesses
History of non-compliance
Facility Information:
Facility Name
Renal Unit, BMA Medical College and Vajira Hospital
City
Bangkok
ZIP/Postal Code
10300
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Short Daily Hemodialysis and Online HDF: Which One is Better?
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