- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00939445
Short Daily Hemodialysis and Online HDF: Which One is Better? (SHD)
December 13, 2015 updated by: Thananda Trakarnvanich, Bangkok Metropolitan Administration Medical College and Vajira Hospital
1. To compare the efficacy of
- Short Daily Hemodialysis
- Online HDF in term of adequacy of dialysis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bangkok, Thailand, 10300
- Renal Unit, BMA Medical College and Vajira Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Online HDF
|
Online HDF
|
Active Comparator: Short Daily Hemodialysis
|
Short Daily Hemodialysis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adequacy
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hematocrit, calcium, phosphorus
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
July 14, 2009
First Submitted That Met QC Criteria
July 14, 2009
First Posted (Estimate)
July 15, 2009
Study Record Updates
Last Update Posted (Estimate)
December 15, 2015
Last Update Submitted That Met QC Criteria
December 13, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VJR-NEPHRO001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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