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High Flux Hemodialysis Thrice Versus Once

NCT ID: NCT00714662

Last Updated: 2008-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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End-Stage Renal Disease

Keywords

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high flux hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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high flux hemodialyzer (FX-60, FX-80 or FX-100)

three sessions per week

Intervention Type DEVICE

Other Intervention Names

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FX-60, FX-80 or FX-100

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mrs. Hsiu-Chin Lee Kidney Research Fund

UNKNOWN

Sponsor Role collaborator

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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National Taiwan University Hospital

Principal Investigators

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Yung-Ming Chen, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yung-Ming Chen, M.D.

Role: CONTACT

Phone: 00886-2-23123456

Email: [email protected]

Facility Contacts

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Yung-Ming Chen, M.D.

Role: primary

Other Identifiers

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200803055R

Identifier Type: -

Identifier Source: org_study_id