Cardiac SurgeryNCT02325726
RRI Compared With NephroCheckTM to Predict Acute Renal Failure After Cardiac Surgery.
An observational study of Cardiac Surgery and Extracorporeal Circulation, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Postoperative acute renal failure is a frequent complication after cardiac surgery. The current practice cannot predict Acute Kidney Injuries (AKI) early enough to reduce a significant kidney assault and prevent an organic dysfunction leading to cortical tubular necrosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery, Extracorporeal Circulation, Nephrocheck
- What is being tested?
- Renal Resistive Index compared with NephroCheckTM
- Type of treatment
- Surgery or procedure
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2014to Nov 2014
- 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 elective cardiac surgery with extracorporeal circulation and who are at risk to develop postoperative Acute Kidney Injury.
Who may be able to join
- Elective patients
- Patients scheduled to receive an extracorporeal circulation
- Patients aged 60 and older
- Patients at risk of postoperative acute kidney injury presenting at least two of the following risk factors:
- Age > 60 years.
- Arteritis defined as severe lower limb arteriopathy or carotid stenosis > 50%
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- Diabetes
- Valvular or combined surgery
- Preoperative intra-aortic balloon pump.
Who cannot join
- Unable to provide informed consent
- Comatose patients
- Patients with dementia
- Patient who underwent a previous sternotomy
- Chronic renal failure (sCr clearance < 30 ml.min-1)
- Renal artery stenosis
Show all 10Show fewer
- Endocarditis
- Emergent surgery
- Nephrotoxic treatment
- Non-sinus cardiac rhythm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Renal Resistive Index Compared With NephroCheckTM to Predict Postoperative Acute Renal Failure in Patients Undergoing Cardiac Surgery.
Postoperative acute renal failure is a frequent complication after cardiac surgery. The current practice cannot predict Acute Kidney Injuries (AKI) early enough to reduce a significant kidney assault and prevent an organic dysfunction leading to cortical tubular necrosis.
Several recent studies in cardiac surgery have shown that, both sonographic criteria, such as the Renal Resistive Index (IRR) and urinary biomarkers can predict AKI promptly. These urinary biomarkers are the 'tissue inhibitor of metalloproteinases' (TIMP-2) and the 'insulin-like growth factor binding protein' (IGFBP7). These two proteins are sought noninvasively, directly in the urine, within the same test called 'NephroCheckTM'. These markers, ultrasonographic and biologic, have the advantage of being easy to perform, accessible and seem to have both high sensitivity and specificity to predict AKI promptly after cardiac surgery. Thus, the IRR and the NephroCheckTM test could become essential tests to guide clinicians in determining rapidly whether a patient will develop AKI. However, so far, no study has compared these markers yet.
Therefore, the aim of this prospective observational study will be to compare the effectiveness of the IRR with the NephroCheckTM to predict AKI promptly after cardiac surgery. The secondary outcome will be to determine the threshold of these markers from which patients will be likely to develop AKI
- Being tested
- Renal Resistive Index compared with NephroCheckTM
- Keywords
- Cardiac surgery, Extracorporeal circulation, Renal failure
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal Resistive Index compared with NephroCheckTMProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Renal Resistive Index/Nephrocheck test | Patients undergoing elective cardiac surgery with extracorporeal circulation and who are at risk to develop postoperative Acute Kidney Injury. Receives: Procedure: Renal Resistive Index compared with NephroCheckTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal Resistive Index compared with NephroCheckTM
Compare the effectiveness of the IRR with the NephroCheckTM to predict AKI after cardiac surgery. AKI will be defined according to the RIFLE criteria.
Measured: Day 0 (inclusion) / after cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2014 (estimated)
- Study startSep 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cédrick ZAOUTER, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325726
- Sponsor's protocol ID
- CHUBX RNI 02/2014
- Status last verified
- Oct 2015
- First submitted
- 21 Dec 2014
- Last updated
- 2 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Resistive Index Compared With NephroCheckTM to Predict Postoperative Acute Renal Failure in Patients Undergoing Cardiac Surgery.
- ClinicalTrials.gov ID
- NCT02325726
- Acronym / sponsor ID
- CHUBX RNI 02/2014
- Keywords
- Cardiac surgery, Extracorporeal circulation, Renal failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 25 Dec 2014 (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 cardiac surgery. The current practice cannot predict Acute Kidney Injuries (AKI) early enough to reduce a significant kidney assault and prevent an organic dysfunction leading to cortical tubular necrosis.
Several recent studies in cardiac surgery have shown that, both sonographic criteria, such as the Renal Resistive Index (IRR) and urinary biomarkers can predict AKI promptly. These urinary biomarkers are the 'tissue inhibitor of metalloproteinases' (TIMP-2) and the 'insulin-like growth factor binding protein' (IGFBP7). These two proteins are sought noninvasively, directly in the urine, within the same test called 'NephroCheckTM'. These markers, ultrasonographic and biologic, have the advantage of being easy to perform, accessible and seem to have both high sensitivity and specificity to predict AKI promptly after cardiac surgery. Thus, the IRR and the NephroCheckTM test could become essential tests to guide clinicians in determining rapidly whether a patient will develop AKI. However, so far, no study has compared these markers yet.
Therefore, the aim of this prospective observational study will be to compare the effectiveness of the IRR with the NephroCheckTM to predict AKI promptly after cardiac surgery. The secondary outcome will be to determine the threshold of these markers from which patients will be likely to develop 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 compared with NephroCheckTMPatients undergoing elective cardiac surgery with extracorporeal circulation and who are at risk to develop postoperative Acute Kidney Injury. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective cardiac surgery with extracorporeal circulation and who are at risk to develop postoperative Acute Kidney Injury.
Key inclusion criteria (9 listed)
- Elective patients
- Patients scheduled to receive an extracorporeal circulation
- Patients aged 60 and older
- Patients at risk of postoperative acute kidney injury presenting at least two of the following risk factors:
Key exclusion criteria (10 listed)
- Unable to provide informed consent
- Comatose patients
- Patients with dementia
- Patient who underwent a previous sternotomy
- Chronic renal failure (sCr clearance < 30 ml.min-1)
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 compared with NephroCheckTM | Procedure or surgery | Renal Resistive Index/Nephrocheck test |
Primary outcome
Renal Resistive Index compared with NephroCheckTM
Time frame: Day 0 (inclusion) / after cardiac surgery
Compare the effectiveness of the IRR with the NephroCheckTM to predict AKI after cardiac surgery. AKI will be defined according to the RIFLE criteria.
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 2 Nov 2015.
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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.
Cédrick ZAOUTER, MD principal investigator
University Hospital, Bordeaux
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 Cardiac Surgery and Extracorporeal Circulation, 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 9 inclusion and 10 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 2 Nov 2015. 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?
Renal Resistive Index compared with NephroCheckTM (time frame: Day 0 (inclusion) / after cardiac surgery). 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 2 Nov 2015.