Comparison of Pre- vs Post-dilution Haemodiafiltration in Children

Comparison of Pre- and Post-dilution Hemodiafiltration Modalities - Effects on Biocompatibility and Solute Clearance in Children

Cardiovascular morbidity and mortality are increased in children on conventional haemodialysis. Haemodiafiltration (HDF) is a newer type of dialysis which has two main types (post-dilution and predilution HDF). Post-dilution HDF is associated with better vascular health, blood pressure and growth in children. Furthermore, pre-dilution HDF is shown to remove a wider spectrum of uremic toxin compared to post-dilution HDF in adults. The investigators need more data to define the optimum dialysis modality for children.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Hypothesis: In children with end stage kidney disease pre-dilution HDF (pre-HDF) achieves improved clearances across a wide molecular weight range compared to post-dilution HDF (post-HDF).

Plan of Investigation: Prevalent patients on thrice weekly HD or HDF who have a single pool Kt/v>1.2 will be randomized in to either study arm A (pre-HDF, post-HDF) or B (post-HDF, pre-HDF) after a conditioning period on post-HDF. Dialysis prescription will be kept constant during study periods including blood flow, dialysate flow, dialysate content, filter type and size. Pre-dialysis and post-dialysis bloods will be drawn at baseline and at the end of each treatment with either modality. Reduction ratios of small and middle molecular weight toxins and protein bound toxins as well as markers of inflammation and nutrition will be compared between two modalities. Assessment of blood pressure (ambulatory blood pressure monitoring) and patient wellbeing (questionnaire) will be performed at the end of each period.

Children will be recruited from paediatric dialysis units in London, Istanbul Heidelberg and Lyon with extension to other centres to be confirmed.

Outcomes: If the results of this study demonstrate better clearance with pre-dilution HDF compared to post-dilution HDF, this will inform a future long-term outcome study comparing different HDF modalities and will contribute to define optimum dialysis modality for children.

Study Type

Observational

Enrollment (Estimated)

25

Contacts and Locations

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

Study Contact

Study Locations

    • Bron
      • Lyon, Bron, France
        • Division of Pediatric Nephrology Hôpital Femme Mère Enfant, Hospices Civils de Lyon
      • Heidelberg, Germany
        • Division of Pediatric Nephrology Center for Pediatrics and Adolescent Medicine
      • Istanbul, Turkey
        • Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty
      • London, United Kingdom
        • Great Ormond Street Children's Hospital

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

5 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Children on thrice weekly maintanenece HD or HDF

Description

Inclusion Criteria:

  1. Patients treated in paediatric dialysis centres between 5-20 years of age
  2. Receiving maintenance haemodialysis with HD or HDF for the preceding 3 months
  3. In post-dilution HDF for at least 4 weeks before the start of the study
  4. Patients with stable vascular access (central line or arteriovenous fistula) and no plan to change access modality for the duration of the study
  5. Provision for ultrapure water for HDF (defined as containing <0.1 colony forming unit /ml and <0.03 endotoxin unit/ml) documented in the month prior to study start

Exclusion Criteria:

  1. Incident dialysis patients (on HD or HDF for < 3 months)
  2. Patients with acute infections in the preceding 2 weeks
  3. Patients with underlying chronic inflammatory disorders (Including vasculitis)
  4. Single pool Kt/V less than 1.2 in the month prior to the study start.
  5. Children who have haemoglobin concentrations lower than 10 g/dL

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Removal of middle molecular weight uremic toxins
Time Frame: 4 weeks
The outcome measure is the difference in Beta2-microglobulin reduction ratios between pre- and post-dilution HDF treatments.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Removal of low molecular weight
Time Frame: 4 weeks
Comparison of urea and creatinine reduction ratios between pre- and post-dilution HDF modalities
4 weeks
Removal of protein bound uremic toxins
Time Frame: 4 weeks
Comparison of indole acetate and p-cresyl sulphate reduction ratios between pre- and post-dilution HDF modalities
4 weeks
Comparison of biocompatibility by using an inflammation markers
Time Frame: 4 weeks
Comparison of high sensitive C reactive protein, interleukin 6 and tumor necrosis factor alfa reduction ratios between pre- and post-dilution HDF modalities
4 weeks
Removal of nutritional markers
Time Frame: 4 weeks
Comparison of Leptin and Ghrelin reduction ratios between pre- and post-dilution HDF modalities
4 weeks
Assessment of blood pressure by Ambulatory blood pressure monitoring (ABPM)
Time Frame: 4 weeks
Comparison of systolic and diastolic blood pressures between pre- and post-dilution HDF modalities
4 weeks
Child Quality of Life (QoL) questionnaire
Time Frame: 4 weeks
Questionnaire including information on post-dialysis recovery time, physical activity, school or college attendance and sleep pattern will be recorded by the patient. Questionnaire will be performed at the end of each period with pre- and post-dilution HDF modality. Scale 1 to 5 - higher scores indicate better outcomes.
4 weeks

Collaborators and Investigators

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

Investigators

  • Study Chair: Rukshana Shroff, MD PhD, Great Ormond Street Children's Hospital, London, UK
  • Principal Investigator: Salim Caliskan, Prof Dr, Istanbul University, Cerrahpasa Medical Faculty, Istanbul, Turkey
  • Principal Investigator: Nur Canpolat, Assoc Prof, Istanbul University, Cerrahpasa Medical Faculty, Istanbul, Turkey
  • Principal Investigator: Ayse Agbas, MD, University of Health Sciences, Haseki Education and Research Hospital, Istanbul, Turkey

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)

February 1, 2021

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

December 11, 2019

First Submitted That Met QC Criteria

December 20, 2019

First Posted (Actual)

December 24, 2019

Study Record Updates

Last Update Posted (Actual)

August 22, 2023

Last Update Submitted That Met QC Criteria

August 21, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 19BO27

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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