Effectiveness of the NephroCheck™ After TAVI

Acute Kidney Injury Clinical Trial

— AKI-TAVI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02976792
• Other study ID #: DC 2016/94
• Status: Completed
• Start date: September 2016
• Est. completion date: February 2017

Study information

• Verified date: November 2016
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients scheduled to undergo a TAVI

Exclusion Criteria:

• Chronic dialysis patients with anuria

Related Conditions & MeSH terms

• Acute Kidney Injury
• Postoperative Acute Renal Failure
• Transcatheter Aortic Valve Implantation
• Wounds and Injuries

Intervention

Procedure:
• Renal Resistive Index/NephroCheck™test
Renal Resistive Index and NephroCheck™ test before TAVI and after TAVI

Locations

Country	Name	City	State
France	BORDEAUX UNIVERSITY HOSPITAL - Haut Lévêque	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.