Analysis of Paediatric Treatments With multiFiltratePRO

NCT06603324 | Not Yet Recruiting

• 1 other identifier: CVVHD-PED-01-EU
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study evaluates the performance of the MultifiltratePro in pediatric mode for Continuous Venovenous Hemodiafiltration (CVVHD) in children. Its primary aim is to assess the efficacy of the MultifiltratePro in paediatric mode, specifically in achieving at least 80% of the prescribed effluent dose within 72 hours. Additionally, the study focuses on the safety of this mode in a paediatric setting, closely monitoring for clinical adverse events, hemodynamic instability, and electrolyte imbalances. Paediatric patients with body weights between 8kg and 40kg will be treated with the MultifiltratePro for a period of up to 10 days, with the treatment duration and approach being tailored to the severity of each patient's condition.

Conditions

Renal Failure; CVVHD

Keywords

Acute Kidney Injury; Renal Replacement Therapy; Haemodiafiltration; Contintious kidney replacement therapy; Paediatric

Outcome Measures

Primary Outcomes (1)

• Effluent dose

  Performance parameters of the paediatric treatment mode of multiFiltratePRO based on the effluent dose (prescribed vs achieved effluent dose) at 72 hours (at least 80% of the machine prescribed dose) are analysed

  0 hours and 72 hours after start of treatment

Study Arms (1)

CVVHD treatment in paediatric mode with multiFiltratePRO

EXPERIMENTAL

Treatment of acute kidney injury paediatric patients with continuous veno-venous haemodiafiltration (CVVHD) in paediatric mode with multiFiltratePRO

Device: CVVHD treatment in paediatric mode with multiFiltratePRO

Interventions

CVVHD treatment in paediatric mode with multiFiltratePRO DEVICE

Treatment of acute kidney injury paediatric patients with continuous veno-venous haemodiafiltration (CVVHD) in paediatric mode with multiFiltratePRO

CVVHD treatment in paediatric mode with multiFiltratePRO

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• General:
• Paediatric Patients:
• Informed consent signed and dated by legal representative and investigator/ authorized physician.
• The minors have received the information referred to in Article 63(2) MDR in a way adapted to their age and mental maturity and from investigators or members of the investigating team who are trained or experienced in working with children.
• The explicit wish of a minor who is capable of forming an opinion and assessing the information referred to in Article 63(2) MDR to refuse participation in, or to withdraw from, the clinical investigation at any time, is respected by the investigator.
• Study-specific:
• Estimated life expectancy greater than 3 days
• Children under 18 years
• Body weight ≥8kg and \<40kg
• Patients with clinical indication for CVVHD

You may not qualify if:

• General:
• Any conditions which could interfere with the patient's ability to comply with the study
• Patient or legal representative is not able to give informed consent according to European Medical Device Regulation and corresponding national regulations
• In case of female patients: pregnancy or lactation period
• Participation in an interventional clinical study during the preceding 30 days
• Previous participation in the same study
• Study-specific:
• Hypersensitivity to heparin or known history of heparin induced thrombocytopenia (HIT Type II)
• Uncontrolled bleeding and coagulation disorders
• Decision to limit therapeutic interventions
• Inability to establish the required vascular access

Sponsors & Collaborators

• Fresenius Medical Care Deutschland GmbH: lead
• Alcedis GmbH: collaborator

Study Sites (1)

Universitätsklinikum Frankfurt

Frankfurt, 60590, Germany

Location

MeSH Terms

Conditions

Renal Insufficiency; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Michael Merker, Dr. med.

  Universitätsklinikum Frankfurt, Klinik für Kinder- und Jugendmedizin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manuela Stauss-Grabo, Dr.

CONTACT

+4961726085248; manuela.stauss-grabo1@freseniusmedicalcare.com

Lena Wachter

CONTACT

+49 6172 2686464; lena.wachter@freseniusmedicalcare.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Treatment of acute kidney injury paediatric patients with continuous veno-venous haemodiafiltration (CVVHD) in paediatric mode with multiFiltratePRO

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)