Comparison of Pre- vs Post-dilution Haemodiafiltration in Children

Haemodiafiltration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04210154
• Other study ID #: 19BO27
• Status: Active, not recruiting
• Start date: February 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Great Ormond Street Hospital for Children NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Haemodiafiltration

Intervention

Device:
• Haemodiafiltration
pre-dilution and post-dilution Haemodiafiltration

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
Great Ormond Street Hospital for Children NHS Foundation Trust	Heidelberg University, Hospices Civils de Lyon, Istanbul University

Countries where clinical trial is conducted

France,  Germany,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks
Secondary	Removal of low molecular weight	Comparison of urea and creatinine reduction ratios between pre- and post-dilution HDF modalities	4 weeks
Secondary	Removal of protein bound uremic toxins	Comparison of indole acetate and p-cresyl sulphate reduction ratios between pre- and post-dilution HDF modalities	4 weeks
Secondary	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	4 weeks
Secondary	Removal of nutritional markers	Comparison of Leptin and Ghrelin reduction ratios between pre- and post-dilution HDF modalities	4 weeks
Secondary	Assessment of blood pressure by Ambulatory blood pressure monitoring (ABPM)	Comparison of systolic and diastolic blood pressures between pre- and post-dilution HDF modalities	4 weeks
Secondary	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.	4 weeks