Effect of Dialysis Membranes on Inflammatory and Immune Processes in Hemodialysis

Sisli Hamidiye Etfal Training and Research Hospital

Status: Completed

Conditions: Kidney Failure; Dialysis Related Complication; Renal Insufficiency, Chronic

Treatments: Device: High-Flux; Device: Medium cut-off

Study type: Interventional

Funder types: Other

Identifiers

NCT03836508

1909

Details and patient eligibility

About

Double blinded, randomized controlled trial evaluating medium cut-off dialyzer compared to high flux dialyzer in ironic hemodialysis patients over a 6 months period with 3 months crossovers.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients who are older than 18 years and younger than 65 years
• patient with end-stage renal disease, hemodialysis more than 6 months
• patients under hemodialysis with high-flux dialyzer more than 3 months
• patients willing to participate after given fair and clear information about study

Exclusion criteria

• patients living with Hepatitis B or C,
• patients with malignancy
• patients under immunosuppressive treatment
• patients with autoimmune diseases such as systemic lupus erythematosus, etc.
• patients with active infections
• patients planned to have a kidney transplantation in 6 months
• patients having vascular access problems
• patients planned to transfer to another center

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

Medium cut-off

Active Comparator group

Description:

Medium cut-off dialyzers will be used in this group containing 26 randomized patients for three months. At the end of the third month with crossover, this groups of patients will start using high-flux dialyzers.

Treatment:

Device: High-Flux

Device: Medium cut-off

High-flux

Active Comparator group

Description:

High-flux dialyzers will be used in this group containing 26 randomized patients for three months. At the end of the third month with crossover, this groups of patients will start using medium cut-off dialyzers.

Treatment:

Device: High-Flux

Device: Medium cut-off