Acute Kidney InjuryNEPHROCARNCT03396770
Acute Kidney Injury After Cardiac Surgery
A study testing Standard clinical routine and Nephrocheck test in people with Acute Kidney Injury and Cardiac Surgery, run by Rennes University Hospital at 1 site in France.
Trial summary
Acute kidney injury (AKI) is common after cardiac surgery. The diagnosis is based on the criteria defined by the Kidney Disease Improving Global Outcomes (KDIGO) classification: oliguria and elevation of serum creatinine. However, oliguria is not specific of AKI and elevation of serum creatinine is too late. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Cardiac Surgery
- What is being tested?
- Standard clinical routine and Nephrocheck test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 848 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jan 2018to 16 Sep 2021
- Phase
- Interventional
- 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
Who may be able to join
- On-pump cardiac surgery ;
- Informed and written consent of the patient or inclusion according to the emergency procedure;
- Affiliated patient or beneficiary of a social protection
Who cannot join
- Left and / or right ventricular assist device;
- Heart transplant;
- Chronic kidney disease with renal replacement therapy before surgery;
- Hemorrhagic shock requiring surgical hemostasis at the time of randomization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the Early Hemodynamic Evaluation Guided by Urinary Biomarkers on the Acute Kidney Injury After Cardiac Surgery
Acute kidney injury (AKI) is common after cardiac surgery. The diagnosis is based on the criteria defined by the Kidney Disease Improving Global Outcomes (KDIGO) classification: oliguria and elevation of serum creatinine. However, oliguria is not specific of AKI and elevation of serum creatinine is too late. Therefore, new methods have been developed to earlier assess the risk of AKI.
Among those methods, it has been shown that the increase of urinary dosage, in the hours following the surgery, of two proteins (Tissue Inhibitor of Metallo-Protease 2 (TIMP2) and Insulin Growth Factor Binding Protein 7 (IGFBP7)) is associated with an increased risk of occurrence of AKI in patients hospitalized in intensive care unit. The Nephrocheck® test combines the urinary dosage of those two proteins TIMP2 and IGFBP7.
Insofar as post-surgery low cardiac output is one curable cause of AKI, the early detection of early kidney risk allows corrective measures to stabilize hemodynamic state and thus to reduce the risk of AKI.
Read the detailed description
The usual diagnostic markers of AKI are defaulted. Indeed, oliguria tends to overstate the impact of AKI, up to 40-50% of patients. Postoperative increased serum creatinine is a late marker for the AKI. Furthermore, perioperative hemodilution and serum creatinine kinetic delay the postoperative peak of serum creatinine from 48 to 72 h.
Nephrocheck® test combines the urinary dosage of 2 proteins (TIMP2 and IGFBP7). These 2 proteins are excreted by the tubular cell in case of suffering whatever the origin, for example tissue hypoxia by low renal blood flow or a systemic inflammatory response. In a medical ICU, the test performed within 4 to 12 hours after kidney aggression can predict the onset of persistent AKI beyond 4 weeks.
Until randomization, all patients are treated according to the standard of care for the center. This includes a blood test upon arrival in the intensive care unit and continuous monitoring of vital parameters.
- Conditions
- Acute Kidney Injury, Cardiac Surgery
- Being tested
- Standard clinical routine, Nephrocheck test
- Keywords
- Urinary biomarkers, Intensive Care Unit
- 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.
Standard clinical routineProcedure or surgery
Patient management is carried out according to the usual service protocol
Nephrocheck testProcedure or surgery
Nephrocheck® test is realized 4 hours after the end of the cardiopulmonary bypass
- If the test is positive, hemodynamic evaluation is carried out and adapted therapy to result of this evaluation is initiated.
- If the test is negative, patient management is carried out according to the usual protocol.
- A second test is realized 6 hours after the first test whatever the result of it.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Standard clinical routine Receives: Procedure: Standard clinical routine |
| Nephrocheck group | Experimental | Nephrocheck test Receives: Procedure: Nephrocheck test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of an AKI according to the KDIGO classification without oliguria
According to the KDIGO classification:
Stage 1; Increase in serum creatinine ≥ 26.5 μmol / l or 1.5 to 1.9 times baseline serum creatinine Stage 2; Increase in baseline serum creatinine from 2.0 to 2.9 times Stage 3; An increase of 3.0 times the baseline serum creatinine or serum creatinine ≥ 354 μmol / l or initiation of renal replacement therapy
Measured: 72 hours after surgery
Secondary outcomes (7)
Filling solute volumes
Recording of the filling solute volumes administered within 48 hours postoperatively
Measured: 48 hours after surgery
Use of catecholamin
Recording (YES/NO) of the recourse of catecholamin required during the medical care, within 48 hours postoperatively
Measured: 48 hours after surgery
Special extra corporeal circulation
Recording (YES/NO) of the recourse of a particular extracorporeal system within 48 hours postoperatively : Extracorporeal Life Support, heart pumps (Impela® like devices), or Intra-aortic balloon pump.
Measured: 48 hours after surgery
Duration of stay in the ward
Measured: Up to 28 days post surgery
Oliguria
Proportion of patients with an oliguria defined according to the KDIGO criteria :
- Stade 1 ; diuresis < 0.5 mL/kg/h for 6 à 12 h
- Stade 2 ; diuresis < 0.5 mL/kg/h for more than 12h
- Stade 3 ; diuresis < 0.3 mL/kg/h for more than 24h or anuria ≥ 12h ;
Measured: 48 hours after surgery
Repeatability of the Nephrocheck® test
Only for the patients in the Nephrocheck arm, variations between pre and postoperative Nephrocheck® test results will be assessed
Measured: 10 hours post surgery
Mortality rate
Mortality rate in the ward
Measured: Up to 28 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2018
- Study start14 Jan 2018
- Primary completion16 Sep 2021
- Study completion16 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- open labeled randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 848 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- JRAR Association
- Responsible party
- Sponsor
- Investigators
- Sébastien BIEDERMANN, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03396770
- Sponsor's protocol ID
- 35RC17_8822
- Other IDs
- 2017-A01935-48
- Acronym
- NEPHROCAR
- Status last verified
- Dec 2021
- First submitted
- 15 Dec 2017
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Early Hemodynamic Evaluation Guided by Urinary Biomarkers on the Acute Kidney Injury After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03396770
- Acronym / sponsor ID
- NEPHROCAR / 35RC17_8822
- Conditions
- Acute Kidney Injury, Cardiac Surgery
- Keywords
- Urinary biomarkers, Intensive Care Unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 848 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- JRAR Association
- Study start
- 14 Jan 2018 (actual)
- Primary completion
- 16 Sep 2021 (actual)
- Study completion
- 16 Sep 2021 (actual)
- First posted
- 11 Jan 2018 (actual)
- 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.
Acute kidney injury (AKI) is common after cardiac surgery. The diagnosis is based on the criteria defined by the Kidney Disease Improving Global Outcomes (KDIGO) classification: oliguria and elevation of serum creatinine. However, oliguria is not specific of AKI and elevation of serum creatinine is too late. Therefore, new methods have been developed to earlier assess the risk of AKI.
Among those methods, it has been shown that the increase of urinary dosage, in the hours following the surgery, of two proteins (Tissue Inhibitor of Metallo-Protease 2 (TIMP2) and Insulin Growth Factor Binding Protein 7 (IGFBP7)) is associated with an increased risk of occurrence of AKI in patients hospitalized in intensive care unit. The Nephrocheck® test combines the urinary dosage of those two proteins TIMP2 and IGFBP7.
Insofar as post-surgery low cardiac output is one curable cause of AKI, the early detection of early kidney risk allows corrective measures to stabilize hemodynamic state and thus to reduce the risk of AKI.
Detailed description
The usual diagnostic markers of AKI are defaulted. Indeed, oliguria tends to overstate the impact of AKI, up to 40-50% of patients. Postoperative increased serum creatinine is a late marker for the AKI. Furthermore, perioperative hemodilution and serum creatinine kinetic delay the postoperative peak of serum creatinine from 48 to 72 h.
Nephrocheck® test combines the urinary dosage of 2 proteins (TIMP2 and IGFBP7). These 2 proteins are excreted by the tubular cell in case of suffering whatever the origin, for example tissue hypoxia by low renal blood flow or a systemic inflammatory response. In a medical ICU, the test performed within 4 to 12 hours after kidney aggression can predict the onset of persistent AKI beyond 4 weeks.
Until randomization, all patients are treated according to the standard of care for the center. This includes a blood test upon arrival in the intensive care unit and continuous monitoring of vital parameters.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open labeled randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: Standard clinical routineStandard clinical routine |
| Nephrocheck group | Experimental | Procedure: Nephrocheck testNephrocheck test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- On-pump cardiac surgery ;
- Informed and written consent of the patient or inclusion according to the emergency procedure;
- Affiliated patient or beneficiary of a social protection
Key exclusion criteria (4 listed)
- Left and / or right ventricular assist device;
- Heart transplant;
- Chronic kidney disease with renal replacement therapy before surgery;
- Hemorrhagic shock requiring surgical hemostasis at the time of randomization
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 |
|---|---|---|
| Standard clinical routinePatient management is carried out according to the usual service protocol | Procedure or surgery | Control group |
| Nephrocheck testNephrocheck® test is realized 4 hours after the end of the cardiopulmonary bypass * If the test is positive, hemodynamic evaluation is carried out and adapted therapy to result of this evaluation is initiated. * If the test is negative, patient management is carried out according to the usual protocol. * A second test is realized 6 hours after the first test whatever the result of it. | Procedure or surgery | Nephrocheck group |
Primary outcome
Occurence of an AKI according to the KDIGO classification without oliguria
Time frame: 72 hours after surgery
According to the KDIGO classification: Stage 1; Increase in serum creatinine ≥ 26.5 μmol / l or 1.5 to 1.9 times baseline serum creatinine Stage 2; Increase in baseline serum creatinine from 2.0 to 2.9 times Stage 3; An increase of 3.0 times the baseline serum creatinine or serum creatinine ≥ 354 μmol / l or initiation of renal replacement therapy
7 secondary outcomes
Filling solute volumes
Time frame: 48 hours after surgery
Use of catecholamin
Time frame: 48 hours after surgery
Special extra corporeal circulation
Time frame: 48 hours after surgery
Duration of stay in the ward
Time frame: Up to 28 days post surgery
Oliguria
Time frame: 48 hours after surgery
Repeatability of the Nephrocheck® test
Time frame: 10 hours post surgery
Mortality rate
Time frame: Up to 28 days post surgery
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 Dec 2021.
- Individual participant dataSharing planned: No
Related trials for Acute Kidney Injury
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Acute-on-Chronic Liver Failure (ACLF)
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Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
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Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
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WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
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.
Sébastien BIEDERMANN, MD principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard clinical routine and Nephrocheck test in people with Acute Kidney Injury and Cardiac Surgery, run by Rennes University Hospital 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 3 inclusion and 4 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 Dec 2021. 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?
Occurence of an AKI according to the KDIGO classification without oliguria (time frame: 72 hours after 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 Dec 2021.