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| Name | Class |
|---|---|
| Mediconomics GmbH | UNKNOWN |
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The goal of this observational study is to assess the performance of the multiFlux hemofilterwith regional or systemic anticoagulation during CKRT treatments. The multiFlux hemofilter is a single use device within the extracorporeal blood circuit during extracorporeal blood purification treatments for acute renal replacement therapies.
Patients enrolled in this clinical investigation will be treated either with citrate anticoagulation in Continuous venovenous hemodialysis (CVVHD) or Continuous venovenous hemodiafiltration (CVVHDF) in post-dilution mode (RCA-post-CVVHDF) with RCA using 4% citrate with Ci-Ca dialysate (without gas barrier)) or with heparin in any of the possible CKRT modes (pre-, post- or pre-post CVVH, CVVHD, pre-, post- or pre-post CVVHDF) for up to 10 days based on investigator´s decision (data beyond 10 days will not be collected within the study) or until withdrawal of informed consent or death.
For the study, treatment data will be documented for a maximum of 10 days.
The selection of the filter size depends on the prescription of the attending physician. The body weight limitations as shall be considered:
Mutiflux 160 ≥ 40 kg, Multiflux 130 ≥ 30 kg, Multiflux 60 ≥ 8 kg
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AKI patients | Patients with acute Kidney Injury (AKI) with clinical indication for CKRT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| multiFlux 160 hemofilter with regional heparin anticoagulation | Device | Extracorporeal blood purification with the multiFlux 160 hemofilter during continuous kidney replacement therapy with RCA systemic heparin anticoagulation for patients suffering from acute kidney injury (AKI) |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of clearance (Creatinine reduction in blood and effluent) as therapy efficacy at specified time points | From enrollment up to 10 days | |
| Assessment of potential electrolyte imbalances or acid base disturbances during RCA treatment | From enrollment up to 10 days |
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Inclusion Criteria:
General:
Patients ≥ 18 years:
Informed consent signed and dated by the investigator; and
if patient is able to give consent: by the study patient
if patients unable to give consent: by the legal representative/spouse according to § 1358 BGB or
if an emergency situation is determined: by an independent consultant physician.
Pediatric Patients < 18 years:
Informed consent signed and dated by legal representative and investigator/ authorized physician.
The minors have received the information referred to in Article 63(2) Medical Device Regulation (MDR) in a way adapted to their age and mental maturity and from investigators or members of the investigating team who are trained or experienced in working with children. If able, the minors have to sign the informed consent, too.
The explicit wish of a minor who is capable of forming an opinion and assessing the information referred to in Article 63(2) MDR to refuse participation in, or to withdraw from, the clinical investigation at any time, is respected by the investigator
Study specific:
Exclusion Criteria:
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The study population consists of critically ill patients (adults and children) requiring continuous kidney replacement therapy (CKRT).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Celina Meyer | Contact | +49 6172 268 6809 | Celina.Meyer@FreseniusMedicalCare.com | |
| Anja Derlet-Savoia, Dr. | Contact | +49 6172 268 6648 | Anja.Derlet@freseniusmedicalcare.com |
| Name | Affiliation | Role |
|---|---|---|
| Christina Scharf-Janßen, PD Dr. med. | LMU University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum der Ludwig-Maximilians-Universität München (LMU Klinikum) | Munich | Bavaria | 81377 | Germany |
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|
| multiFlux 160 hemofilter with RCA with regional citrate anticoagulation | Device | Extracorporeal blood purification with the multiFlux 160 hemofilter during continuous kidney replacement therapy with RCA using 4% citrate with Ci-Ca dialysate (without gas barrier) for patients suffering from acute kidney injury (AKI) |
|
| multiFlux 130 hemofilter with regional heparin anticoagulation | Device | Extracorporeal blood purification with the multiFlux 130 hemofilter during continuous kidney replacement therapy with RCA systemic heparin anticoagulation for patients suffering from acute kidney injury (AKI) |
|
| multiFlux 130 hemofilter with RCA with regional citrate anticoagulation | Device | Extracorporeal blood purification with the multiFlux130 hemofilter during continuous kidney replacement therapy with RCA using 4% citrate with Ci-Ca dialysate (without gas barrier) for patients suffering from acute kidney injury (AKI) |
|
| multiFlux 60 hemofilter with regional heparin anticoagulation | Device | Extracorporeal blood purification with the multiFlux 60 hemofilter during continuous kidney replacement therapy with RCA systemic heparin anticoagulation for patients suffering from acute kidney injury (AKI) |
|
| multiFlux 60 hemofilter with RCA with regional citrate anticoagulation | Device | Extracorporeal blood purification with the multiFlux 60 hemofilter during continuous kidney replacement therapy with RCA using 4% citrate with Ci-Ca dialysate (without gas barrier) for patients suffering from acute kidney injury (AKI) |
|
| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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