Effectiveness of the NephroCheck™ After TAVI

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02976792

Acronym

AKI-TAVI

Enrollment

Registered

2016-11-29

Start date

2016-09-30

Completion date

2017-02-28

Last updated

2024-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Transcatheter aortic valve implantation, Acute Kidney Injury, early acute kidney injury detection, Nephrocheck™, Renal Resistive Index

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.

Interventions

PROCEDURERenal Resistive Index/NephroCheck™test

Renal Resistive Index and NephroCheck™ test before TAVI and after TAVI

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* patients scheduled to undergo a TAVI

Exclusion criteria

* Chronic dialysis patients with anuria

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026