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

NCT06236984 | Completed

• 1 other identifier: CKRT-AKI-01-EU
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 3

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.

Conditions

Acute Kidney Injury; Renal Failure

Keywords

Continuous kidney replacement therapy

Outcome Measures

Primary Outcomes (1)

• Analysis of treatments with multiFiltratePRO

  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

Study Arms (1)

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

Interventions

multiFiltratePRO with all CKRT treatment modes OTHER

Retrospective Data Analysis of CKRT treatments in adult mode with multiFiltratePRO

AKI patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Participation in an interventional clinical study during the retrospectively collected CKRT treatment data
• Previous participation in the same study

Sponsors & Collaborators

• Fresenius Medical Care Deutschland GmbH: lead
• Metronomia Clinical Research GMBH: collaborator

Study Sites (3)

Evangelisches Klinikum Bethel gGmbH Universitätsklinikum OWL der Universität Bielefeld

Bielefeld, North Rhine-Westphalia, 33617, Germany

Location

Klinikum Leverkusen gGmbH

Leverkusen, North Rhine-Westphalia, 51375, Germany

Location

Klinikum Ludwigshafen

Ludwigshafen am Rhein, Rhineland-Palatinate, 67063, Germany

Location

MeSH Terms

Conditions

Acute Kidney Injury; Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Rainer Borgstedt, Dr. med.

  Evangelisches Klinikum Bethel gGmbH Universitätsklinikum OWL der Universität Bielefeld

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: February 1, 2024
• Study Start: May 1, 2024
• Primary Completion: February 21, 2025
• Study Completion: February 21, 2025
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)