Acute Kidney Injury Clinical Trial
— CKRT-AKIOfficial title:
Retrospective Data Analysis of CKRT Treatments in Adult Mode With multiFiltratePRO
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.
| Status | Not yet recruiting |
| Enrollment | 250 |
| Est. completion date | December 2024 |
| Est. primary completion date | September 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Fresenius Medical Care Deutschland GmbH | Metronomia Clinical Research GMBH |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |
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