Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
848 participants
INTERVENTIONAL
2018-01-14
2021-09-16
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Control group
Standard clinical routine
Standard clinical routine
Patient management is carried out according to the usual service protocol
Nephrocheck group
Nephrocheck test
Nephrocheck test
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.
Interventions
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Standard clinical routine
Patient management is carried out according to the usual service protocol
Nephrocheck test
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.
Eligibility Criteria
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Inclusion Criteria
* Informed and written consent of the patient or inclusion according to the emergency procedure;
* Affiliated patient or beneficiary of a social protection
Exclusion Criteria
* Heart transplant;
* Chronic kidney disease with renal replacement therapy before surgery;
* Hemorrhagic shock requiring surgical hemostasis at the time of randomization
18 Years
ALL
No
Sponsors
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JRAR Association
UNKNOWN
Rennes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Sébastien BIEDERMANN, MD
Role: PRINCIPAL_INVESTIGATOR
CHU Rennes
Locations
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Rennes University Hospital
Rennes, , France
Countries
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Other Identifiers
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2017-A01935-48
Identifier Type: OTHER
Identifier Source: secondary_id
35RC17_8822
Identifier Type: -
Identifier Source: org_study_id