Analysis of Continuous Kidney Replacement Therapy (CKRT) Treatments With multiFlux Hemofilters Using Regional Citrate Anticoagulation (RCA) or Systemic Heparin Anticoagulation
RCA-Flux
Analysis of CKRT Treatments With multiFlux Hemofilters Using RCA or Systemic Heparin Anticoagulation
1 other identifier
observational
62
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2026
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2026
CompletedFirst Posted
Study publicly available on registry
July 1, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
July 1, 2026
June 1, 2026
11 months
June 25, 2026
June 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (1)
AKI patients
Patients with acute Kidney Injury (AKI) with clinical indication for CKRT
Interventions
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)
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)
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)
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)
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)
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)
Eligibility Criteria
The study population consists of critically ill patients (adults and children) requiring continuous kidney replacement therapy (CKRT).
You may qualify if:
- 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:
- Body weight ≥ 8kg
- Acute Kidney Injury (AKI) with clinical indication for CKRT
- Clinically estimated life expectancy greater than 3 days
You may not qualify if:
- 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
- Uncontrolled bleeding and coagulation disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fresenius Medical Care Deutschland GmbHlead
- Mediconomics GmbHcollaborator
Study Sites (1)
Klinikum der Ludwig-Maximilians-Universität München (LMU Klinikum)
Munich, Bavaria, 81377, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christina Scharf-Janßen, PD Dr. med.
LMU University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2026
First Posted
July 1, 2026
Study Start
July 1, 2026
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
July 1, 2026
Record last verified: 2026-06