Clinical trial NCT03942744: The Effect of High-flux Hemodialysis and On-line Hemodiafiltration on Endothelial Function.
Official title: Molecular Mechanisms Involved in Cell Adhesion and Migration Process: Effect of Treatment of Chronic Kidney Disease on Endothelial Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease Requiring Chronic Dialysis
Keywords: Hemodialysis
Endothelial dysfunction
Atherogenesis
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2019-05-08
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: prospective randomized crossover study
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Effect of two different dialysis modalities (high flux vs online hemodiafiltration) on endothelial function markers: CD31,CD41,CD34; as measured by the percent of labeled cells obtained by flow cytometry.
timeFrame: 6 months
Secondary outcomes:
measure: Effect of two different dialysis modalities ( high flux vs online hemodiafiltration) on hospitalization (hospital admission days/year).
timeFrame: 6 months
measure: Effect of two different dialysis modalities ( high flux vs online hemodiafiltration) on Serum concentration of Fibroblast Growth Factor FGF23 (pg/ml) .
timeFrame: 6 months
measure: Effect of two different dialysis modalities ( high flux vs online hemodiafiltration) on vascular injury related microRNAs (relative expression)
timeFrame: 6 months
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Hospital universitario Reina Sofia
state: Cordoba
city: Cordoba
country: Spain
facility: Alejandro Martinmalo
state: Córdoba
Study officials:
affiliation: Maimónides Biomedical Research Institute of Córdoba
name: alejandro martin-malo, MD
role: PRINCIPAL_INVESTIGATOR
References: