Safety and Performance Evaluation of multiPlus Dialysate During CRRT

Study Overview
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Brief Summary
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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).

Official Title
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Safety and Performance Evaluation of multiPlus Dialysate During CRRT

Conditions
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Acute Kidney Injury

Intervention / Treatment
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* Device: multiPlus dialysate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, non-comparative, multi-centre, open-label, interventional, post market clinical follow-up (PMCF) study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: multiPlus dialysate<br>Treatment of acute kidney injury patients either with continuous veno-venous haemodialysis (CVVHD) or continuous veno-venous haemodiafiltration (CVVHDF) using the multiPlus dialysate. | Device: multiPlus dialysate<br>* Treatment of acute kidney injury patients either with continuous veno-venous haemodialysis (CVVHD) or continuous veno-venous haemodiafiltration (CVVHDF) using the multiPlus dialysate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum creatinine removal | 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). | 360 min after start | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal replacement therapy, Acute kidney injury, Haemodialysis, Haemodiafiltration