High Flux Hemodialysis Thrice Versus Once

July 11, 2008 updated by: National Taiwan University Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

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

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Principal Investigator:
          • Yung-Ming Chen, M.D.
        • Contact:

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

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
blood pressure, fluid balance, and indices of nutrition, inflammation, and dialysis adequacy
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

Mrs. Hsiu-Chin Lee Kidney Research Fund

Investigators

  • Principal Investigator: Yung-Ming Chen, M.D., National Taiwan University Hospital

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, 2008

Primary Completion (Anticipated)

February 1, 2009

Study Completion (Anticipated)

March 1, 2009

Study Registration Dates

First Submitted

July 9, 2008

First Submitted That Met QC Criteria

July 11, 2008

First Posted (Estimate)

July 14, 2008

Study Record Updates

Last Update Posted (Estimate)

July 14, 2008

Last Update Submitted That Met QC Criteria

July 11, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200803055R

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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