Transcatheter Aortic Valve ImplantationAKI-TAVINCT02976792
Effectiveness of the NephroCheck™ After TAVI
An observational study of Transcatheter Aortic Valve Implantation and Acute Kidney Injury, run by University Hospital, Bordeaux at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transcatheter Aortic Valve Implantation, Acute Kidney Injury, Postoperative Acute Renal Failure
- What is being tested?
- Renal Resistive Index/NephroCheck™test
- Type of treatment
- Surgery or procedure
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2016to Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing a TAVI procedure
Who may be able to join
- patients scheduled to undergo a TAVI
Who cannot join
- Chronic dialysis patients with anuria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of the NephroCheck™ to Predict Postoperative Acute Kidney Injury in Patients Undergoing a Transcatheter Aortic Valve Implantation
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
- Being tested
- Renal Resistive Index/NephroCheck™test
- Keywords
- Transcatheter aortic valve implantation, Acute Kidney Injury, early acute kidney injury detection, Nephrocheck™, Renal Resistive Index
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal Resistive Index/NephroCheck™testProcedure or surgery
Renal Resistive Index and NephroCheck™ test before TAVI and after TAVI
| Study group | Role | What they receive |
|---|---|---|
| Renal Resistive Index/NephroCheck™test | Patients undergoing a transcatheter aortic valve implantation Receives: Procedure: Renal Resistive Index/NephroCheck™test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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™
compare the NephroCheck™ with the Renal Resistive Index in predicting an AKI
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startSep 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcatheter Aortic Valve ImplantationStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandre OUATTARA, University Hospital, Bordeaux
- Investigators
- Alexandre OUATTARA, MD, PhD, Principal investigator, head of anesthesia department II
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976792
- Sponsor's protocol ID
- DC 2016/94
- Acronym
- AKI-TAVI
- Status last verified
- May 2024
- First submitted
- 11 Oct 2016
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the NephroCheck™ to Predict Postoperative Acute Kidney Injury in Patients Undergoing a Transcatheter Aortic Valve Implantation
- ClinicalTrials.gov ID
- NCT02976792
- Acronym / sponsor ID
- AKI-TAVI / DC 2016/94
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 29 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal Resistive Index/NephroCheck™test | – | Procedure: Renal Resistive Index/NephroCheck™testPatients undergoing a transcatheter aortic valve implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing a TAVI procedure
Key inclusion criteria (1 listed)
- patients scheduled to undergo a TAVI
Key exclusion criteria (1 listed)
- Chronic dialysis patients with anuria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renal Resistive Index/NephroCheck™testRenal Resistive Index and NephroCheck™ test before TAVI and after TAVI | Procedure or surgery | Renal Resistive Index/NephroCheck™test |
Primary outcome
Effectiveness of the NephroCheck™ test to detect AKI after TAVI
Time frame: 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.
1 secondary outcome
Renal Resistive Index compared with NephroCheck™
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No
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Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis.
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
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Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation
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Recruiting
Ambulatory Electrocardiographic Monitoring for the Detection of High-Degree Atrio-Ventricular Block in Patients With New-onset PeRsistent LEft Bundle Branch Block After Transcatheter Aortic Valve Implantation. The "MARE" Study
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Not yet recruiting
Effect of Double-Tap Optimization on Valve Expansion and Hemodynamics in Balloon-expandable Transcatheter Aortic Valve Implantation: A Randomized Clinical Trial (DO-OPT TAVI Trial)
Severe Aortic Stenosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre OUATTARA, MD, PhD principal investigator
head of anesthesia department II
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transcatheter Aortic Valve Implantation and Acute Kidney Injury, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of the NephroCheck™ test to detect AKI after TAVI (time frame: 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.)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.