Clinical trial NCT03396770: Acute Kidney Injury After Cardiac Surgery
Official title: Impact of the Early Hemodynamic Evaluation Guided by Urinary Biomarkers on the Acute Kidney Injury After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Cardiac Surgery
Keywords: Urinary biomarkers
Intensive Care Unit
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: JRAR Association
First posted: 2018-01-11
Enrollment: 848
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: open labeled randomized clinical trial
Primary purpose: DIAGNOSTIC

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion criteria:

* 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

Primary outcomes:
measure: Occurence of an AKI according to the KDIGO classification without oliguria
timeFrame: 72 hours after surgery
Secondary outcomes:
measure: Filling solute volumes
timeFrame: 48 hours after surgery
measure: Use of catecholamin
timeFrame: 48 hours after surgery
measure: Special extra corporeal circulation
timeFrame: 48 hours after surgery
measure: Duration of stay in the ward
timeFrame: Up to 28 days post surgery
measure: Oliguria
timeFrame: 48 hours after surgery
measure: Repeatability of the Nephrocheck® test
timeFrame: 10 hours post surgery
measure: Mortality rate
timeFrame: Up to 28 days post surgery
Other outcomes:
Locations:
city: Rennes
country: France
facility: Rennes University Hospital
Study officials:
affiliation: CHU Rennes
name: Sébastien BIEDERMANN, MD
role: PRINCIPAL_INVESTIGATOR
References: