- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04210154
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
Study Overview
Status
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Rukshana Shroff, MD PhD
- Phone Number: +44 207 813 8513
- Email: rushana.shroff@gosh.nhs.uk
Study Locations
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Bron
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Lyon, Bron, France
- Division of Pediatric Nephrology Hôpital Femme Mère Enfant, Hospices Civils de Lyon
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Heidelberg, Germany
- Division of Pediatric Nephrology Center for Pediatrics and Adolescent Medicine
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Istanbul, Turkey
- Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty
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London, United Kingdom
- Great Ormond Street Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients treated in paediatric dialysis centres between 5-20 years of age
- Receiving maintenance haemodialysis with HD or HDF for the preceding 3 months
- In post-dilution HDF for at least 4 weeks before the start of the study
- Patients with stable vascular access (central line or arteriovenous fistula) and no plan to change access modality for the duration of the study
- 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:
- Incident dialysis patients (on HD or HDF for < 3 months)
- Patients with acute infections in the preceding 2 weeks
- Patients with underlying chronic inflammatory disorders (Including vasculitis)
- Single pool Kt/V less than 1.2 in the month prior to the study start.
- Children who have haemoglobin concentrations lower than 10 g/dL
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Removal of middle molecular weight uremic toxins
Time Frame: 4 weeks
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The outcome measure is the difference in Beta2-microglobulin reduction ratios between pre- and post-dilution HDF treatments.
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Removal of low molecular weight
Time Frame: 4 weeks
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Comparison of urea and creatinine reduction ratios between pre- and post-dilution HDF modalities
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4 weeks
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Removal of protein bound uremic toxins
Time Frame: 4 weeks
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Comparison of indole acetate and p-cresyl sulphate reduction ratios between pre- and post-dilution HDF modalities
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4 weeks
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Comparison of biocompatibility by using an inflammation markers
Time Frame: 4 weeks
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Comparison of high sensitive C reactive protein, interleukin 6 and tumor necrosis factor alfa reduction ratios between pre- and post-dilution HDF modalities
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4 weeks
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Removal of nutritional markers
Time Frame: 4 weeks
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Comparison of Leptin and Ghrelin reduction ratios between pre- and post-dilution HDF modalities
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4 weeks
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Assessment of blood pressure by Ambulatory blood pressure monitoring (ABPM)
Time Frame: 4 weeks
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Comparison of systolic and diastolic blood pressures between pre- and post-dilution HDF modalities
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4 weeks
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Child Quality of Life (QoL) questionnaire
Time Frame: 4 weeks
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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.
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4 weeks
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Collaborators and Investigators
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
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 19BO27
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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