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

NCT ID: NCT06236984

Last Updated: 2025-06-10

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

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-02-21

Brief Summary

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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

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Conditions

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Acute Kidney Injury Renal Failure

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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AKI patients

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

multiFiltratePRO with all CKRT treatment modes

Intervention Type OTHER

Retrospective Data Analysis of CKRT treatments in adult mode with multiFiltratePRO

Interventions

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multiFiltratePRO with all CKRT treatment modes

Retrospective Data Analysis of CKRT treatments in adult mode with multiFiltratePRO

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Metronomia Clinical Research GMBH

UNKNOWN

Sponsor Role collaborator

Fresenius Medical Care Deutschland GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rainer Borgstedt, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Evangelisches Klinikum Bethel gGmbH Universitätsklinikum OWL der Universität Bielefeld

Locations

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Evangelisches Klinikum Bethel gGmbH Universitätsklinikum OWL der Universität Bielefeld

Bielefeld, North Rhine-Westphalia, Germany

Site Status

Klinikum Leverkusen gGmbH

Leverkusen, North Rhine-Westphalia, Germany

Site Status

Klinikum Ludwigshafen

Ludwigshafen am Rhein, Rhineland-Palatinate, Germany

Site Status

Countries

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Germany

Other Identifiers

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CKRT-AKI-01-EU

Identifier Type: -

Identifier Source: org_study_id

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