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

March 29, 2022 updated by: Alejandro Martin-Malo, Maimónides Biomedical Research Institute of Córdoba

Molecular Mechanisms Involved in Cell Adhesion and Migration Process: Effect of Treatment of Chronic Kidney Disease on Endothelial Dysfunction

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Cordoba
      • Córdoba, Cordoba, Spain, 14004
        • Hospital Universitario Reina Sofía
    • Córdoba
      • Cordoba, Córdoba, Spain, 14004
        • Alejandro Martinmalo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: high-flux hemodialysis
high-flux hemodialysis cut-off membrane above 50
Active Comparator: on-line hemodiafiltration
postdilutional on-line hemodiafiltration with a convective transport above 21 liters
Device: on-line hemodiafiltration
on-line postdilutional hemodiafiltration with high convective transport above 21 liters

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 6 months
These parameters will assessed, in patients with chronic kidney disease (CKD5D), Blood will be drawn before the dialysis session following the scheduled of the protocol. The measuremets of CD31 CD41 CD34 will be performend by flow cytometry according to the standard methodology described in methods.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of two different dialysis modalities ( high flux vs online hemodiafiltration) on hospitalization (hospital admission days/year).
Time Frame: 6 months
Effect of two different dialysis modalities ( high flux vs online hemodiafiltration) on hospitalization (hospital admission days/year). Cardiovascular causes and concurrent cardiovascular events throughout the study (acute myocardial infarction, stroke, transient ischemic attack and peripheral vascular disease) will be also recorded throughout the study.
6 months
Effect of two different dialysis modalities ( high flux vs online hemodiafiltration) on Serum concentration of Fibroblast Growth Factor FGF23 (pg/ml) .
Time Frame: 6 months
The serum concentration of Fibroblast Growth Factor FGF23 will be quantified using commercially available ELISA Kit. (pg/ml). Blood samples will be obtained before the dialysis session.
6 months
Effect of two different dialysis modalities ( high flux vs online hemodiafiltration) on vascular injury related microRNAs (relative expression)
Time Frame: 6 months
The relative expression of microRNAs (126-3p, 223-3p,363-3p, 191-5p). will be determined by RTq-PCR. Blood samples will be obtained before the dialysis session.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maimónides Biomedical Research Institute of Córdoba

Collaborators

Instituto de Salud Carlos III

Investigators

  • Principal Investigator: alejandro martin-malo, MD, Maimónides Biomedical Research Institute of Córdoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2018

Primary Completion (Actual)

November 30, 2021

Study Completion (Actual)

February 25, 2022

Study Registration Dates

First Submitted

March 5, 2019

First Submitted That Met QC Criteria

May 7, 2019

First Posted (Actual)

May 8, 2019

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 29, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI17/01785

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The individual data will be available in this report after deidenttification (text, tables, figures and appendices) to those researchers who provide a methodologically sound proposal and for meta-analysis.

IPD Sharing Time Frame

The data will be available after the end of the study until one year the article publication.

IPD Sharing Access Criteria

To obtain the data, a proposal must be sent to uicec@imibic.org. To gain access, data requestors will need to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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