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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal Resistive Index/NephroCheck™test | Patients undergoing a transcatheter aortic valve implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal Resistive Index/NephroCheck™test | Procedure | Renal Resistive Index and NephroCheck™ test before TAVI and after TAVI |
|
| 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.) |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing a TAVI procedure
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| Name | Affiliation | Role |
|---|---|---|
| Alexandre OUATTARA, MD, PhD | head of anesthesia department II | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BORDEAUX UNIVERSITY HOSPITAL - Haut Lévêque | Pessac | 33604 | France |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |