NCT06603324

Analysis of Paediatric Treatments With multiFiltratePRO

Efficacy and Safety of Paediatric CVVHD Treatment With MultiFiltratePRO: A Prospective Multicenter Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: Fresenius Medical Care Deutschland GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Failure
• CVVHD

Interventions

Type	Name	Description
DEVICE	CVVHD treatment in paediatric mode with multiFiltratePRO	Treatment of acute kidney injury paediatric patients with continuous veno-venous haemodiafiltration (CVVHD) in paediatric mode with multiFiltratePRO

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-10-01
• Completion: 2026-12-01
• First posted: 2024-09-19
• Last updated: 2025-09-04

Locations

1 site across 1 country: Germany