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

June 5, 2025 updated by: Fresenius Medical Care Deutschland GmbH

Retrospective Data Analysis of CKRT Treatments in Adult Mode With multiFiltratePRO

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Nordrhein-Westfalen
      • Bielefeld, Nordrhein-Westfalen, Germany, 33617
        • Evangelisches Klinikum Bethel gGmbH Universitätsklinikum OWL der Universität Bielefeld
      • Leverkusen, Nordrhein-Westfalen, Germany, 51375
        • Klinikum Leverkusen gGmbH
    • Rheinland-Pfalz
      • Ludwigshafen, Rheinland-Pfalz, Germany, 67063
        • Klinikum Ludwigshafen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients with an indication for the extracorporeal blood treatment suffering from AKI who received CKRT adult mode treatment

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AKI patients
Patients with an indication for the extracorporeal blood treatment suffering from AKI who received CKRT adult mode treatment
Other: multiFiltratePRO with all CKRT treatment modes
Retrospective Data Analysis of CKRT treatments in adult mode with multiFiltratePRO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of treatments with multiFiltratePRO
Time Frame: 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
documentation of max.7 treatment days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fresenius Medical Care Deutschland GmbH

Collaborators

Metronomia Clinical Research GMBH

Investigators

  • Principal Investigator: Rainer Borgstedt, Dr. med., Evangelisches Klinikum Bethel gGmbH Universitätsklinikum OWL der Universität Bielefeld

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Actual)

February 21, 2025

Study Completion (Actual)

February 21, 2025

Study Registration Dates

First Submitted

January 5, 2024

First Submitted That Met QC Criteria

January 24, 2024

First Posted (Actual)

February 1, 2024

Study Record Updates

Last Update Posted (Actual)

June 10, 2025

Last Update Submitted That Met QC Criteria

June 5, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CKRT-AKI-01-EU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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