Analysis of Continuous Kidney Replacement Therapy (CKRT) Treatments With multiFlux Hemofilters Using Regional Citrate Anticoagulation (RCA) or Systemic Heparin Anticoagulation
- Sponsor
- Fresenius Medical Care Deutschland GmbH
- Study ID
- NCT07679568
- Status
- Not Yet Recruiting
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Conditions
- Acute Kidney Injury
- Renal Failure
Eligibility Criteria
- Sex
- ALL
- Age
- 1 Year - N/A
- Healthy Volunteers
- Not accepted
Interventions
- 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)
Study Details
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.
Key Dates
- First listed
- Jul 1, 2026
- Start date
- Jul 31, 2026
- Status verified
- Jun 2026
- Primary completion
- Jun 30, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 62 participants (estimated)
Arms
- Arm: AKI patientsPatients with acute Kidney Injury (AKI) with clinical indication for CKRT
Primary Outcome Measure
Rate of clearance (Creatinine reduction in blood and effluent) as therapy efficacy at specified time points [ Time Frame: From enrollment up to 10 days ]
Central Contacts
- Celina Meyer+49 6172 268 6809
- Anja Derlet-Savoia, Dr.+49 6172 268 6648
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