Analysis of Paediatric Treatments With multiFiltratePRO
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorFresenius Medical Care Deutschland GmbH
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Estimated life expectancy greater than 3 days
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
CVVHD treatment in paediatric mode with multiFiltratePRO
DeviceTreatment of acute kidney injury paediatric patients with continuous veno-venous haemodiafiltration (CVVHD) in paediatric mode with multiFiltratePRO
Treatment groups
43 Participants
are divided into 1 treatment groupGroup A: CVVHD treatment in paediatric mode with multiFiltratePROExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Effluent dose
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
Time frame
0 hours and 72 hours after start of treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Fresenius Medical Care Deutschland GmbH
Lead sponsor
Alcedis GmbH
Collaborator
Source ClinicalTrials.gov