Status:
TERMINATED
Safety and Performance Evaluation of multiPlus Dialysate During CRRT
Lead Sponsor:
Fresenius Medical Care Deutschland GmbH
Collaborating Sponsors:
Winicker Norimed GmbH
Conditions:
Acute Kidney Injury
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Assessment of the performance of multiPlus dialysate based on the serum creatinine removal 6 hours (360 min) after start of continuous veno-venous haemodialysis/ haemodiafiltration \[CVVHD(F)\]. mult...
Eligibility Criteria
Inclusion
- Signed and dated informed consent form by investigator and by
- a) the study patient: if patient is able to consent
- b) the legal representative: if patient is unable to consent:
- c) an independent consultant: in case of emergency
- if c) either legal representative or study patient, whichever can be done sooner, should be informed by the investigator as soon as possible. If the informed consent has been obtained by the legal representative (b or emergency scenario) informed consent to continue the participation in the clinical investigation shall be obtained from the subject as soon as he or she is capable of giving informed consent (According to the MDR - Article 68 - Clinical investigations in emergency situations)
- Minimum age of 18 years
- Ability to understand the nature and requirements of the study (if patient is conscious)
- Study specific:
- Body weight greater than 40 kg
- Acute Kidney Injury (AKI) with clinical indication for CVVHD/CVVHDF
- Vascular access allowing blood flow of min 50mL/min
- Estimated life expectancy greater than 3 days
Exclusion
- Any conditions which could interfere with the patient's ability to comply with the study
- In case of female patients: pregnancy (negative pregnancy test for women below 55 years) or lactation period
- Participation in an interventional clinical study during the preceding 30 days
- Previous participation in the same study
- SARS-CoV 2 positive
- Study specific
- Hyperphosphataemia (\>4.5 mg/dL)
- Hypersensitivity to heparin or known history of heparin induced thrombocytopenia (HIT Type II)
- Uncontrolled bleeding and coagulation disorders
- Decision to limit therapeutic interventions
- Advanced malignancy (not including myeloma)
- Dementia (if definitely not an acute confusional state from uraemia or other acute illness)
- Advanced cirrhosis with encephalopathy in the absence of possible liver transplantation
Key Trial Info
Start Date :
May 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2023
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT05315817
Start Date
May 31 2022
End Date
January 24 2023
Last Update
January 9 2024
Active Locations (1)
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1
Leipzig Heart Institute GmbH
Leipzig, Saxony, Germany, 04289