Pediatric use of multiFiltratePRO for CVVHD in kids

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study evaluates the pediatric configuration of the multiFiltratePRO system for continuous venovenous hemodiafiltration in children weighing 8 to 40 kg. It aims to determine if the device can achieve 80% of the prescribed effluent dose within 72 hours and to monitor safety, including adverse events, hemodynamic changes, and electrolyte balance. Treatment may last up to 10 days and is tailored to the patient’s condition, with dosing and duration adjusted by clinical status. Eligible participants are children under 18 with a clinical indication for CVVHD and a life expectancy beyond 3 days, enrolled with informed consent from guardians and assent from capable minors as required. The study is sponsored by Fresenius Medical Care Deutschland GmbH, with collaboration from Alcedis GmbH, and conducted at centers in Ostrava and Frankfurt.

Why it matters

Who can join: the full rules

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

Where it's running

• Fakultní nemocnice Ostrava
  Ostrava-Poruba, Czechia Recruiting
• Universitätsklinikum Frankfurt
  Frankfurt, Germany Recruiting

Study contacts

• Principal investigator: Michael Merker, Dr. med. — Universitätsklinikum Frankfurt, Klinik für Kinder- und Jugendmedizin
• Study coordinator: Jana Schmitt
• Email: Jana.Schmitt@freseniusmedicalcare.com
• Phone: +49 6172 268 6305

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.