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High Flux Hemodialysis Thrice Versus Once

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00714662
Enrollment
80
Registered
2008-07-14
Start date
2008-06-30
Completion date
2009-03-31
Last updated
2008-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-Stage Renal Disease

Keywords

high flux hemodialysis

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.

Interventions

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

three sessions per week

Sponsors

Mrs. Hsiu-Chin Lee Kidney Research Fund
CollaboratorUNKNOWN
National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
blood pressure, fluid balance, and indices of nutrition, inflammation, and dialysis adequacy6 months

Countries

Taiwan

Contacts

Primary ContactYung-Ming Chen, M.D.
chenym@ntuh.gov.tw00886-2-23123456

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026