The Effect of High-flux Hemodialysis and On-line Hemodiafiltration on Endothelial Function.

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

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-08

Study Completion Date

2022-02-25

Brief Summary

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The main aim of this project is to evaluate, in patients with chronic kidney disease (CKD5D), the role of adhesion molecules in leukocyte adhesion and transendothelial migration involved in atherogenesis. This trial is a prospective randomized crossover study in CKD5D hemodialysis patients followed in the Nephrology Unit of the Reina Sofia University Hospital (Cordoba, Spain). The estimated inclusion period is two years, with a follow-up of 24 months. Patients will be randomized to high-flux hemodialysis versus online hemodiafiltration with high convective transport (above 21 liters); after 6 months in each dialysis modality they will be switched the other technique for another 6 months. Then, patients will be maintained during 4 weeks in conventional hemodialysis "wash out period", before being started in the other dialysis modality.

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Detailed Description

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The main aim of this project is to evaluate, in patients with chronic kidney disease (CKD5D), the role of adhesion molecules in leukocyte adhesion and transendothelial migration involved in atherogenesis. This trial is a prospective randomized crossover study in CKD5D hemodialysis patients followed in the Nephrology Unit of the Reina Sofia University Hospital (Cordoba, Spain). The estimated inclusion period is two years, with a follow-up of 24 months. Patients will be randomized to high-flux hemodialysis versus online hemodiafiltration with high convective transport (above 21 liters); after 6 months in each dialysis modality they will be switched the other technique for another 6 months. Then, patients will be maintained during 4 weeks in conventional hemodialysis "wash out period", before being started in the other dialysis modality. Patients will be stratified by age, gender and the presence of diabetes. Routine analytical determinations (urea, creatinine, sodium, potassium, chlorine, total CO2, calcium, phosphorus, FA, PTH, levels 25OH, β2m, ALT, hemoglobin, leukocytes, platelets, glucose, uric acid, total proteins, albumin , PCR, IL-6, ferritin, TSAT and homocysteine), characteristics of hemodialysis and dialysis dose (Kt / V and Kt) will be recorded. Residual renal function will be analysed every three months. In plasma, microRNAs profile and FGF23 levels will be determined. Markers of endothelial dysfunction (CD31 +, CD41-, CD144, CD62E) and subclinical atherosclerosis markers (CD11b, CD41 +) will be measured. The hospitalization and mortality rate due to cardiovascular causes and concurrent cardiovascular events throughout the study (acute myocardial infarction, stroke, transient ischemic attack and peripheral vascular disease) will be assessed along the study period.

Conditions

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Chronic Kidney Disease Requiring Chronic Dialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

prospective randomized crossover study

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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high-flux hemodialysis

high-flux hemodialysis cut-off membrane above 50

Group Type NO_INTERVENTION

No interventions assigned to this group

on-line hemodiafiltration

postdilutional on-line hemodiafiltration with a convective transport above 21 liters

Group Type ACTIVE_COMPARATOR

on-line hemodiafiltration

Intervention Type DEVICE

on-line postdilutional hemodiafiltration with high convective transport above 21 liters

Interventions

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on-line hemodiafiltration

on-line postdilutional hemodiafiltration with high convective transport above 21 liters

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Vascular access with a blood flow \> 300ml/min
* Age \>18 \<80 years written informed consent

Exclusion Criteria

* Neoplasia
* B hepatitis
* Acute or chronic inflammation life expectance less than one year Included in living donor transplant list immunosupressive drugs

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No