Clinical trial NCT06236984: Retrospective Data Analysis of CKRT (Continuous Kidney Replacement Therapy) Treatments in Adult Mode With multiFiltratePRO
Official title: Retrospective Data Analysis of CKRT Treatments in Adult Mode With multiFiltratePRO
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Renal Failure
Keywords: Continuous kidney replacement therapy
Lead sponsor: Fresenius Medical Care Deutschland GmbH
Sponsor class: INDUSTRY
Collaborators: name: Metronomia Clinical Research GMBH
First posted: 2024-02-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Analysis of treatments with multiFiltratePRO
timeFrame: documentation of max.7 treatment days
Secondary outcomes:
Other outcomes:
Locations:
city: Bielefeld
country: Germany
facility: Evangelisches Klinikum Bethel gGmbH Universitätsklinikum OWL der Universität Bielefeld
state: Nordrhein-Westfalen
city: Leverkusen
country: Germany
facility: Klinikum Leverkusen gGmbH
state: Nordrhein-Westfalen
city: Ludwigshafen
country: Germany
facility: Klinikum Ludwigshafen
state: Rheinland-Pfalz
Study officials:
affiliation: Evangelisches Klinikum Bethel gGmbH Universitätsklinikum OWL der Universität Bielefeld
name: Rainer Borgstedt, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: