Acute Kidney Injury
Conditions
Keywords
Renal replacement therapy, Acute kidney injury, Haemodialysis, Haemodiafiltration
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 \[CVVHD(F)\]. multiPlus is a phosphate-containing dialysis solution for the use in continuous renal replacement therapy (CRRT) during acute kidney injury (AKI).
Interventions
DEVICEmultiPlus dialysate
Treatment of acute kidney injury patients either with continuous veno-venous haemodialysis (CVVHD) or continuous veno-venous haemodiafiltration (CVVHDF) using the multiPlus dialysate.
Sponsors
Winicker Norimed GmbH
Fresenius Medical Care Deutschland GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, non-comparative, multi-centre, open-label, interventional, post market clinical follow-up (PMCF) study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum creatinine removal | 360 min after start | The primary variable of this clinical investigation is serum creatinine removal (arterial pre-filter sample taking) assessed 6 hours (360 min) after start of CVVHD(F). |
Countries
Germany
Outcome results
None listed