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Clinical Trials/NCT06236984
NCT06236984
Completed
Not Applicable

Retrospective Data Analysis of CKRT Treatments in Adult Mode With multiFiltratePRO

Fresenius Medical Care Deutschland GmbH3 sites in 1 country80 target enrollmentStarted: May 1, 2024Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
80
Locations
3
Primary Endpoint
Analysis of treatments with multiFiltratePRO

Overview

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.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (3)

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