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NCT Number: NCT06603324

Analysis of Paediatric Treatments With multiFiltratePRO

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.

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum Frankfurt

Frankfurt, 60590, Germany

Location contact

Michael Merker, Dr. med.

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

Primary outcomes

  1. Effluent dose

    Time frame: 0 hours and 72 hours after start of treatment

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Lena Wachter

CONTACT

[email protected]

+49 6172 2686464

Manuela Stauss-Grabo, Dr.

CONTACT

[email protected]

+4961726085248

Sponsors and collaborators

Lead sponsor

Fresenius Medical Care Deutschland GmbH

Industry

Collaborators

  • Alcedis GmbH

Registry information

Official study title

Efficacy and Safety of Paediatric CVVHD Treatment With MultiFiltratePRO: A Prospective Multicenter Study

Acronym: ECHOped

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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