Back to resultsHigh Flux Hemodialysis Thrice Versus Once
Primary Purpose
End-Stage Renal Disease
Status
Unknown status
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
high flux hemodialyzer (FX-60, FX-80 or FX-100)
Sponsored by
About this trial
This is an interventional treatment trial for End-Stage Renal Disease focused on measuring high flux hemodialysis
Eligibility Criteria
Inclusion Criteria:
- ESRD patients under regular thrice weekly HD for more than 3 months in NTUH HD center.
- Age: 18~80 years old.
- Blood flow during dialysis ≧ 250ml/min
Exclusion Criteria:
- Previous allergy to heparin or FX series dialyzer (FX-60, FX-80, FX-100)
- Pre-dialysis systolic blood pressure ≦ 100mmHg (2week prior to enrollment)
- Bacteremia, myocardial infarction or stroke in previous 3 months.
- Known diagnosis with dialysis related amyloidosis
Sites / Locations
- National Taiwan University HospitalRecruiting
Outcomes
Primary Outcome Measures
blood pressure, fluid balance, and indices of nutrition, inflammation, and dialysis adequacy
Secondary Outcome Measures
Full Information
NCT ID
NCT00714662
First Posted
July 9, 2008
Last Updated
July 11, 2008
Sponsor
National Taiwan University Hospital
Collaborators
Mrs. Hsiu-Chin Lee Kidney Research Fund
1. Study Identification
Unique Protocol Identification Number
NCT00714662
Brief Title
High Flux Hemodialysis Thrice Versus Once
Official Title
Effects of Different Frequencies of High-Flux Membranes on Blood Pressure, Fluid Balance, and Indices of Nutrition, Inflammation, and Dialysis Adequacy in Chronic Hemodialysis Patients - Comparisons Between Thrice vs Once Weekly
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Unknown status
Study Start Date
June 2008 (undefined)
Primary Completion Date
February 2009 (Anticipated)
Study Completion Date
March 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
National Taiwan University Hospital
Collaborators
Mrs. Hsiu-Chin Lee Kidney Research Fund
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To investigate the influence of different dialysis frequencies on the outcome of end-stage renal disease patients undergoing chronic hemodialysis therapy.
Detailed Description
This study will be conducted in the HD center at NTUH. Patients undergoing chronic HD for at least 6 months will be evaluated for eligibility. Patients with previous adverse reactions to FX series dialyzer will not be included in this study. Detailed demographic physical characteristics of the participants will be recorded, including age, gender, underlying diseases, blood pressure, intradialytic complications, as well as indices of nutrition, inflammation, and dialysis adequacy. Eligible patients will first undergo a 4-week run-in HD with conventional-flux dialyzer twice weekly plus high-flux dialyzer once weekly (i.e., basic formula), followed by random allocation into two separate groups. Patients in group A will continue HD with the basic formula, while those in group B will receive HD using high-flux membranes thrice weekly. Three months later, all participants will be put back on HD with basic formula for 1 month (wash-out period). Group A patients will then be switched to receive HD with high-flux membranes thrice weekly, and group B patients will be changed to undergo HD with basic formula for another 3 months. Laboratory tests will include monthly biochemistry and hemogram, plus blood and urine specimens taken on 4 occasions before and during the study (baseline, end of the first 3 months, end of wash-out, and end of the second 3 months) to investigate selective markers and indices for nutrition, inflammation, and dialysis adequacy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-Stage Renal Disease
Keywords
high flux hemodialysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
high flux hemodialyzer (FX-60, FX-80 or FX-100)
Other Intervention Name(s)
FX-60, FX-80 or FX-100
Intervention Description
three sessions per week
Primary Outcome Measure Information:
Title
blood pressure, fluid balance, and indices of nutrition, inflammation, and dialysis adequacy
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ESRD patients under regular thrice weekly HD for more than 3 months in NTUH HD center.
Age: 18~80 years old.
Blood flow during dialysis ≧ 250ml/min
Exclusion Criteria:
Previous allergy to heparin or FX series dialyzer (FX-60, FX-80, FX-100)
Pre-dialysis systolic blood pressure ≦ 100mmHg (2week prior to enrollment)
Bacteremia, myocardial infarction or stroke in previous 3 months.
Known diagnosis with dialysis related amyloidosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yung-Ming Chen, M.D.
Phone
00886-2-23123456
Ext
5993
Email
chenym@ntuh.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yung-Ming Chen, M.D.
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yung-Ming Chen, M.D.
Phone
00886-2-23123456
Ext
5993
Email
chenym@ntuh.gov.tw
First Name & Middle Initial & Last Name & Degree
Yung-Ming Chen, M.D.
12. IPD Sharing Statement
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High Flux Hemodialysis Thrice Versus Once
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