Effectiveness of the NephroCheck™ After TAVI

Completed

• Conditions: Acute Kidney Injury; Postoperative Acute Renal Failure; Transcatheter Aortic Valve Implantation
• Interventions: Procedure: Renal Resistive Index/NephroCheck™test

• Registration Number: NCT02976792
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-10-11
• Study First Submitted QC: 2016-11-28
• Study First Posted: 2016-11-29
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• patients scheduled to undergo a TAVI

Exclusion Criteria

• Chronic dialysis patients with anuria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Renal Resistive Index/NephroCheck™test	Renal Resistive Index/NephroCheck™test	Patients undergoing a transcatheter aortic valve implantation

Primary Outcome Measures

Name	Time	Method
Effectiveness of the NephroCheck™ test to detect AKI after TAVI	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.)	Determine the efficacy of NephroCheck™ test to predict AKI after TAVI. AKI will be defined according to the KADIGO criteria.

Secondary Outcome Measures

Name	Time	Method
Renal Resistive Index compared with NephroCheck™	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.	compare the NephroCheck™ with the Renal Resistive Index in predicting an AKI

Trial Locations

Locations (1)

BORDEAUX UNIVERSITY HOSPITAL - Haut Lévêque; 🇫🇷 Pessac, France