Effectiveness of the NephroCheck™ After TAVI

Study Overview
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Brief Summary
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Postoperative acute renal failure is a frequent complication after a Transcatheter Aortic Valve Implantation (TAVI). The current practice cannot predict Acute Kidney Injuries (AKI) early enough to prevent an organic dysfunction triggering, consequently, cortical tubular necrosis. Several recent studies in cardiac surgery have shown that sonographic criteria, the Renal Resistive Index (IRR), and a urinary biomarker, the NephroCheck™, could predict AKI promptly. These markers, sonographic and biologic, have both the advantage to be non-invasive and easy to perform. Each marker seems to have sensitivity and specificity to predict AKI promptly after cardiac surgery. Therefore, the IRR and the NephroCheck™ test could become essential tests to guide clinicians in determining rapidly whether a patient will develop AKI after a TAVI procedure. However, so far, no study has tested the NephroCheck™ in patients undergoing TAVI. Therefore, the aim of this prospective observational study will be first to determine the effectiveness of the NephroCheck™ to predict AKI at an early stage after a TAVI procedure. The secondary outcome will be to compare the NephroCheck™ with the RRI in predicting at an earlier stage than the traditional method an AKI.

Official Title
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Effectiveness of the NephroCheck™ to Predict Postoperative Acute Kidney Injury in Patients Undergoing a Transcatheter Aortic Valve Implantation

Conditions
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Transcatheter Aortic Valve Implantation, Acute Kidney Injury, Postoperative Acute Renal Failure

Intervention / Treatment
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* Procedure: Renal Resistive Index/NephroCheck™test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients scheduled to undergo a TAVI Exclusion Criteria: Chronic dialysis patients with anuria

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Renal Resistive Index/NephroCheck™test<br>Patients undergoing a transcatheter aortic valve implantation | Procedure: Renal Resistive Index/NephroCheck™test<br>* Renal Resistive Index and NephroCheck™ test before TAVI and after TAVI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of the NephroCheck™ test to detect AKI after TAVI | Determine the efficacy of NephroCheck™ test to predict AKI after TAVI. AKI will be defined according to the KADIGO criteria. | Evolution of the Nephrocheck test from the time 0 to time 2.(Time 0: at inclusion before the TAVI / Time 1: NephroCheck™ Test at the first micturition post TAVI / Time 2: NephroCheck test™ on the first post operative day at the first micturition.) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal Resistive Index compared with NephroCheck™ | compare the NephroCheck™ with the Renal Resistive Index in predicting an AKI | Evolution of the Renal Resistive Index from time 0 to time 2. Time 0: at inclusion before the TAVI / Time 1: at the first micturition post TAVI/ Time 2: on the first post operative day at the first micturition. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcatheter aortic valve implantation, Acute Kidney Injury, early acute kidney injury detection, Nephrocheck™, Renal Resistive Index