The Effect of High-flux Hemodialysis and On-line Hemodiafiltration on Endothelial Function.
Condition: Chronic Kidney Disease Requiring Chronic Dialysis
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

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.
    

Intervention name(s): on-line hemodiafiltration
Intervention type(s): Device
Intervention description(s): on-line postdilutional hemodiafiltration with high convective transport above 21 liters
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: prospective randomized crossover study
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Hemodialysis; Endothelial dysfunction; Atherogenesis