Retrospective Data Analysis of CKRT (Continuous Kidney Replacement Therapy) Treatments in Adult Mode With multiFiltratePRO

Recruiting

• Conditions: Renal Failure; Acute Kidney Injury
• Interventions: Other: multiFiltratePRO with all CKRT treatment modes

• Registration Number: NCT06236984
• Lead Sponsor: Fresenius Medical Care Deutschland GmbH

Brief Summary

The multiFiltratePRO is a device for extracorporeal blood purification treatments.

In this retrospective analysis, the treatments of patients who received at least one treatment with the investigational device as mentioned between January 2015 and January 2024 will be documented in a chronological order. No further control treatments will be investigated in this one-arm design. The design is considered to be appropriate to reflect daily clinical practice and to contribute to empirical evidence of performance of the multiFiltratePRO system.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-05
• Study First Submitted QC: 2024-01-24
• Study First Posted: 2024-02-01
• Study Start: 2024-05-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Primary Completion: 2025-03-14
• Last Update Posted: 2025-03-14
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• All patients with an indication for the extracorporeal blood treatment suffering from AKI who received CKRT adult mode treatment for at least once with: Heparin-Continuous veno-venous hemofiltration Hep-CVVH (Pre CVVH, Post CVVH and Pre-Post CVVH), Heparin-Continuous veno-venous hemodialysis Hep-CVVHD, Heparin-Continuous veno-venous hemodiafiltration Hep-CVVHDF (Pre-CVVHDF and Post-CVVHDF), Citrate-Calcium(Ci-Ca)-CVVHD, Citrate-Calcium(Ci-Ca) CVVHDF, between January 2015 and January 2024, with the investigational device, have to be included in the study in chronological order.
• No age restriction for heparin modes
• Age ≥ 18 years for Ci-Ca modes at treatment start
• Patient´s body weight ≥ 40kg irrespective of age
• Acute Kidney Injury (AKI) OR chronic dialysis patients with clinical indication for CKRT

Exclusion Criteria

• Participation in an interventional clinical study during the retrospectively collected CKRT treatment data
• Previous participation in the same study
• No study-specific exclusion criteria based on contraindications due to the retrospective character of the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AKI patients	multiFiltratePRO with all CKRT treatment modes	Patients with an indication for the extracorporeal blood treatment suffering from AKI who received CKRT adult mode treatment

Primary Outcome Measures

Name	Time	Method
Analysis of treatments with multiFiltratePRO	documentation of max.7 treatment days	Performance data of defined multiFiltratePRO CKRT treatments in adult mode with regard to fluid balance (effluent dose) are analysed

Trial Locations

Locations (3)

Evangelisches Klinikum Bethel gGmbH Universitätsklinikum OWL der Universität Bielefeld; 🇩🇪 Bielefeld, Nordrhein-Westfalen, Germany

Klinikum Leverkusen gGmbH; 🇩🇪 Leverkusen, Nordrhein-Westfalen, Germany

Klinikum Ludwigshafen; 🇩🇪 Ludwigshafen, Rheinland-Pfalz, Germany