Analysis of Paediatric Treatments with MultiFiltratePRO

Not Applicable

Not yet recruiting

• Conditions: Renal Failure; CVVHD
• Interventions: Device: CVVHD treatment in paediatric mode with multiFiltratePRO

• Registration Number: NCT06603324
• Lead Sponsor: Fresenius Medical Care Deutschland GmbH

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-22
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-18
• Last Update Submitted: 2024-09-18
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Study Start: 2025-02
• Primary Completion: 2026-02
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CVVHD treatment in paediatric mode with multiFiltratePRO	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

Primary Outcome Measures

Name	Time	Method
Effluent dose	0 hours and 72 hours after start of treatment	Performance parameters of the paediatric treatment mode of multiFiltratePRO based on the effluent dose (prescribed vs achieved effluent dose) at 72 hours (at least 80% of the machine prescribed dose) are analysed