Comparison of Pre- vs Post-dilution Haemodiafiltration in Children

NCT04210154 | Unknown

• 1 other identifier: 19BO27
• Study Type: observational
• Target: 25
• Locations: 4 countries
• Sites: 4

Brief 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.

Conditions

Haemodiafiltration

Keywords

Haemodiafiltration; Haemodialysis; Children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Removal of low molecular weight

  4 weeks

• Removal of protein bound uremic toxins

  4 weeks

• Comparison of biocompatibility by using an inflammation markers

  4 weeks

• Removal of nutritional markers

  4 weeks

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

  4 weeks

Interventions

Haemodiafiltration DEVICE

pre-dilution and post-dilution Haemodiafiltration

Eligibility Criteria

• Age: 5 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Children on thrice weekly maintanenece HD or HDF

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Great Ormond Street Hospital for Children NHS Foundation Trust: lead
• Istanbul University: collaborator
• Heidelberg University: collaborator
• Hospices Civils de Lyon: collaborator

Study Sites (4)

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

Lyon, Bron, France

Location

Division of Pediatric Nephrology Center for Pediatrics and Adolescent Medicine

Heidelberg, Germany

Location

Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty

Istanbul, Turkey (Türkiye)

Location

Great Ormond Street Children's Hospital

London, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum only

MeSH Terms

Interventions

Hemodiafiltration

Intervention Hierarchy (Ancestors)

Renal Dialysis; Renal Replacement Therapy; Therapeutics; Sorption Detoxification; Hemofiltration; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Rukshana Shroff, MD PhD

  Great Ormond Street Children's Hospital, London, UK

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 24, 2019
• Study Start: February 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: August 22, 2023

Record last verified: 2023-08

Locations

TU (1); FR (1); GB (1); DE (1)