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

F

Fresenius Medical Care (FMC)

Status

Enrolling

Conditions

Renal Failure
Acute Kidney Injury

Treatments

Other: multiFiltratePRO with all CKRT treatment modes

Study type

Observational

Funder types

Industry
Other

Identifiers

NCT06236984
CKRT-AKI-01-EU

Details and patient eligibility

About

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.

Enrollment

250 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

250 participants in 1 patient group

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

Trial contacts and locations

3

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Central trial contact

Saynab Atiye; Manuela Stauss-Grabo, Dr.

Data sourced from clinicaltrials.gov

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