Analysis of Paediatric Treatments with MultiFiltratePRO (ECHOped)

Fresenius Medical Care (FMC)

Status

Not yet enrolling

Conditions

Renal Failure

CVVHD

Treatments

Device: CVVHD treatment in paediatric mode with multiFiltratePRO

Study type

Interventional

Funder types

Industry

Identifiers

NCT06603324

CVVHD-PED-01-EU

Details and patient eligibility

About

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.

Enrollment

43 estimated patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

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