About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- multiFlux 160 hemofilter with regional heparin anticoagulation
- multiFlux 160 hemofilter with RCA with regional citrate anticoagulation
- multiFlux 130 hemofilter with regional heparin anticoagulation
- multiFlux 130 hemofilter with RCA with regional citrate anticoagulation
- multiFlux 60 hemofilter with regional heparin anticoagulation
- multiFlux 60 hemofilter with RCA with regional citrate anticoagulation
Treatment groups
Locations
1Sponsors and collaborators
Fresenius Medical Care Deutschland GmbH
Lead sponsor
Mediconomics GmbH
Collaborator