Comparison of Pre- vs Post-dilution Haemodiafiltration in Children

Great Ormond Street Hospital for Children NHS Foundation Trust25 enrolled

Overview

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.

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

Conditions

Haemodiafiltration

Interventions

HaemodiafiltrationDEVICE

pre-dilution and post-dilution Haemodiafiltration

Eligibility

Sex: ALLMin age: 5 YearsMax age: 20 Years

Medical Language ↔ Plain English

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

Locations (4)

Division of Pediatric Nephrology Hôpital Femme Mère Enfant, Hospices Civils de Lyon

Lyon, Bron, France

Division of Pediatric Nephrology Center for Pediatrics and Adolescent Medicine

Heidelberg, Germany

Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty

Istanbul, Turkey (Türkiye)

Great Ormond Street Children's Hospital

London, United Kingdom

Outcomes

Primary Outcomes

Removal of middle molecular weight uremic toxins

The outcome measure is the difference in Beta2-microglobulin reduction ratios between pre- and post-dilution HDF treatments.

Time frame: 4 weeks

Secondary Outcomes

Removal of low molecular weight

Comparison of urea and creatinine reduction ratios between pre- and post-dilution HDF modalities

Time frame: 4 weeks

Removal of protein bound uremic toxins

Comparison of indole acetate and p-cresyl sulphate reduction ratios between pre- and post-dilution HDF modalities

Time frame: 4 weeks

Comparison of biocompatibility by using an inflammation markers

Comparison of high sensitive C reactive protein, interleukin 6 and tumor necrosis factor alfa reduction ratios between pre- and post-dilution HDF modalities

Time frame: 4 weeks

Removal of nutritional markers

Comparison of Leptin and Ghrelin reduction ratios between pre- and post-dilution HDF modalities

Time frame: 4 weeks

Assessment of blood pressure by Ambulatory blood pressure monitoring (ABPM)

Comparison of systolic and diastolic blood pressures between pre- and post-dilution HDF modalities

Time frame: 4 weeks

Child Quality of Life (QoL) questionnaire

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.

Data from ClinicalTrials.gov

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