Analysis of Continuous Kidney Replacement Therapy (CKRT) Treatments With multiFlux Hemofilters Using Regional Citrate Anticoagulation (RCA) or Systemic Heparin Anticoagulation

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1+
SponsorFresenius Medical Care Deutschland GmbH

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

62 Participants
are divided into 1 treatment group

Locations

1
Klinikum der Ludwig-Maximilians-Universität München (LMU Klinikum)81377, MunichBavaria, Germany

Sponsors and collaborators

Fresenius Medical Care Deutschland GmbH

Lead sponsor

Mediconomics GmbH

Collaborator