Status:
NOT_YET_RECRUITING
Analysis of Paediatric Treatments With multiFiltratePRO
Lead Sponsor:
Fresenius Medical Care Deutschland GmbH
Collaborating Sponsors:
Alcedis GmbH
Conditions:
Renal Failure
CVVHD
Eligibility:
All Genders
Up to 18 years
Phase:
NA
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 th...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT06603324
Start Date
October 1 2025
End Date
December 1 2026
Last Update
September 4 2025
Active Locations (1)
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1
Universitätsklinikum Frankfurt
Frankfurt, Germany, 60590