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High Flux Hemodialysis Thrice Versus Once

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Mrs. Hsiu-Chin Lee Kidney Research Fund
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00714662
First received: July 9, 2008
Last updated: July 11, 2008
Last verified: July 2008
History of Changes
  Purpose

To investigate the influence of different dialysis frequencies on the outcome of end-stage renal disease patients undergoing chronic hemodialysis therapy.


Condition Intervention Phase
End-Stage Renal Disease
 Device: high flux hemodialyzer (FX-60, FX-80 or FX-100)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • blood pressure, fluid balance, and indices of nutrition, inflammation, and dialysis adequacy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: June 2008
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: high flux hemodialyzer (FX-60, FX-80 or FX-100)
    three sessions per week
    Other Name: FX-60, FX-80 or FX-100
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ESRD patients under regular thrice weekly HD for more than 3 months in NTUH HD center.
  2. Age: 18~80 years old.
  3. Blood flow during dialysis ≧ 250ml/min

Exclusion Criteria:

  1. Previous allergy to heparin or FX series dialyzer (FX-60, FX-80, FX-100)
  2. Pre-dialysis systolic blood pressure ≦ 100mmHg (2week prior to enrollment)
  3. Bacteremia, myocardial infarction or stroke in previous 3 months.
  4. Known diagnosis with dialysis related amyloidosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00714662

Contacts
Contact: Yung-Ming Chen, M.D. 00886-2-23123456 ext 5993 chenym@ntuh.gov.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Yung-Ming Chen, M.D.     00886-2-23123456 ext 5993     chenym@ntuh.gov.tw    
Principal Investigator: Yung-Ming Chen, M.D.            
Sponsors and Collaborators
National Taiwan University Hospital
Mrs. Hsiu-Chin Lee Kidney Research Fund
Investigators
Principal Investigator: Yung-Ming Chen, M.D. National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Yung-Ming Chen/M.D., National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00714662     History of Changes
Other Study ID Numbers: 200803055R
Study First Received: July 9, 2008
Last Updated: July 11, 2008
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
high flux hemodialysis

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on June 18, 2013