Acute Kidney Injury After Cardiac Surgery (NEPHROCAR)

Rennes University Hospital

Status: Completed

Conditions: Cardiac Surgery; Acute Kidney Injury

Treatments: Procedure: Standard clinical routine; Procedure: Nephrocheck test

Study type: Interventional

Funder types: Other

Identifiers

NCT03396770

35RC17_8822

2017-A01935-48 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 848 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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848 participants in 2 patient groups

Control group

Active Comparator group

Description:

Standard clinical routine

Treatment:

Procedure: Standard clinical routine

Nephrocheck group

Experimental group

Description:

Nephrocheck test

Treatment:

Procedure: Nephrocheck test