Analysis of Paediatric Treatments with MultiFiltratePRO

Launched by FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH · Sep 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a special machine called the MultifiltratePro, which is used for a type of kidney treatment known as Continuous Venovenous Hemodiafiltration (CVVHD) in children. The main goal is to see how well this machine works for kids weighing between 8 kg and 40 kg who have kidney failure. Researchers want to ensure that the machine can deliver the right amount of treatment safely over a period of up to 10 days. They will closely monitor the children for any side effects or problems during the treatment.

To participate in the trial, children need to be under 18 years old, have a life expectancy of more than three days, and must meet certain health criteria for using the CVVHD treatment. It's also important that a parent or guardian can give informed consent, which means they understand the study and agree for their child to take part. The study will not begin recruiting participants just yet, but it represents an important step in finding safe and effective treatments for children with kidney issues.

Gender

ALL

Eligibility criteria

• 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