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NCT06603324
Analysis of Paediatric Treatments With multiFiltratePRO
Conditions: Renal Failure, CVVHD
Sex: All
Ages: N/A – 18 Years
Healthy volunteers: No
Phase: NA
Enrollment: 43
Sponsor: Fresenius Medical Care Deutschland GmbH
Location: Fakultní nemocnice Ostrava Ostrava-Poruba
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 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.
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 \
Source: ClinicalTrials.gov (NCT06603324). StuddyBuddy aggregates publicly available trial information.