Effect of Dialysis Membranes on Inflammatory and Immune Processes in Hemodialysis

Not Applicable

Completed

• Conditions: Kidney Failure; Renal Insufficiency, Chronic; Dialysis Related Complication
• Interventions: Device: Medium cut-off; Device: High-Flux

• Registration Number: NCT03836508
• Lead Sponsor: Sisli Hamidiye Etfal Training and Research Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2019-01-20
• Study First Submitted QC: 2019-02-07
• Study First Posted: 2019-02-11
• Primary Completion: 2019-07-01
• Study Completion: 2019-07-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-17
• Last Update Posted: 2020-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Medium cut-off	Medium cut-off	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.
High-flux	High-Flux	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.
Medium cut-off	High-Flux	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.
High-flux	Medium cut-off	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.

Primary Outcome Measures

Name	Time	Method
Comparison of pre and post-dialysis of Interleukin (IL) 17-A	3 months	Comparison of pre and post-dialysis of IL-17A

Secondary Outcome Measures

Name	Time	Method
Comparison of pre and post-dialysis of IL-10	3 months	Comparison of pre and post-dialysis of IL-10
Comparison of pre and post-dialysis of Interferon (IFN) gama	3 months	Comparison of pre and post-dialysis of IFN gama
Comparison of pre and post-dialysis necrosis factor (TNF) alpha	3 months	Comparison of pre and post-dialysis of TNF alpha
Comparison of pre and post-dialysis of IL-4	3 months	Comparison of pre and post-dialysis of IL-4
Comparison of pre and post-dialysis of Urea	3 months	Comparison of pre and post-dialysis of Urea
Comparison of pre and post-dialysis of creatinine	3 months	Comparison of pre and post-dialysis of creatinine
Comparison of pre and post-dialysis of beta2 microglobulin	3 months	Comparison of pre and post-dialysis of beta2 microglobulin
Comparison of pre and post-dialysis of free light chain kappa	3 months	Comparison of pre and post-dialysis of free light chain kappa
Comparison of pre and post-dialysis of free light chain lambda	3 months	Comparison of pre and post-dialysis of free light chain lambda
Comparison of pre and post-dialysis of myoglobulin	3 months	Comparison of pre and post-dialysis of myoglobulin
Comparison of pre and post-dialysis of fibroblast growth factor (FGF) 23	3 months	Comparison of pre and post-dialysis of FGF 23
Comparison of pre and post-dialysis IL-18 levels	3 months	Comparison of pre and post-dialysis IL-18 levels
Comparison of pre and post-dialysis monocyte chemoattractant protein (MCP)-1 levels	3 months	Comparison of pre and post-dialysis MCP-1 levels
Comparison of pre and post-dialysis NACHT, LRR and PYD domains-containing protein3 (NLRP3) levels	3 months	Comparison of pre and post-dialysis NLRP3 levels
Comparison of pre and post-dialysis regulated on activation, normal T cell expressed and secreted (RANTES)	3 months	Comparison of pre and post-dialysis RANTES

Trial Locations

Locations (1)

Sisli Hamidiye Etfal Training and Research Hospital; 🇹🇷 Istanbul, Turkey