Analysis of Paediatric Treatments With multiFiltratePRO

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Renal Failure CVVHD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Treatment of acute kidney injury paediatric patients with continuous veno-venous haemodiafiltration (CVVHD) in paediatric mode with multiFiltratePRO

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

CVVHD treatment in paediatric mode with multiFiltratePRO

Intervention Type DEVICE

Treatment of acute kidney injury paediatric patients with continuous veno-venous haemodiafiltration (CVVHD) in paediatric mode with multiFiltratePRO

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No