Effectiveness of the NephroCheck™ After TAVI

NCT02976792 | Completed

• 1 other identifier: DC 2016/94
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (1)

Renal Resistive Index/NephroCheck™test

Patients undergoing a transcatheter aortic valve implantation

Procedure: Renal Resistive Index/NephroCheck™test

Interventions

Renal Resistive Index/NephroCheck™test PROCEDURE

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

Renal Resistive Index/NephroCheck™test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing a TAVI procedure

You may qualify if:

• patients scheduled to undergo a TAVI

You may not qualify if:

• Chronic dialysis patients with anuria

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

BORDEAUX UNIVERSITY HOSPITAL - Haut Lévêque

Pessac, 33604, France

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Alexandre OUATTARA, MD, PhD

  head of anesthesia department II

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department of Cardiovascular Anesthesia and Critical care

Study Record Dates

• First Submitted: October 11, 2016
• First Posted: November 29, 2016
• Study Start: September 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)