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.
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.
Any conditions which could interfere with the patient's ability to comply with the study
Patient or legal representative or authorized physician during emergency situation is not able to give informed consent according to European Medical Device Regulation and corresponding national regulations
Participation in a different interventional clinical study during the preceding 30 days
Previous participation in the same study
The study population consists of critically ill patients (adults and children) requiring continuous kidney replacement therapy (CKRT).
Cohort
Prospective
multiFlux 160 hemofilter with regional heparin anticoagulation
DeviceExtracorporeal 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)
multiFlux 160 hemofilter with RCA with regional citrate anticoagulation
DeviceExtracorporeal 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
DeviceExtracorporeal 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
DeviceExtracorporeal 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
DeviceExtracorporeal 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
DeviceExtracorporeal 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)
Rate of clearance (Creatinine reduction in blood and effluent) as therapy efficacy at specified time points
Assessment of potential electrolyte imbalances or acid base disturbances during RCA treatment
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Fresenius Medical Care Deutschland GmbH
Lead sponsor
Mediconomics GmbH
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
