Acute Kidney Injury After Cardiac Surgery

Not Applicable

Completed

• Conditions: Cardiac Surgery; Acute Kidney Injury
• Interventions: Procedure: Nephrocheck test; Procedure: Standard clinical routine

• Registration Number: NCT03396770
• Lead Sponsor: Rennes University Hospital

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.

Study Timeline

• Study First Submitted: 2017-12-15
• Study First Submitted QC: 2018-01-10
• Study First Posted: 2018-01-11
• Study Start: 2018-01-14
• Primary Completion: 2021-09-16
• Study Completion: 2021-09-16
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-01
• Last Update Posted: 2021-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 848

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nephrocheck group	Nephrocheck test	Nephrocheck test
Control group	Standard clinical routine	Standard clinical routine

Primary Outcome Measures

Name	Time	Method
Occurence of an AKI according to the KDIGO classification without oliguria	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

Secondary Outcome Measures

Name	Time	Method
Filling solute volumes	48 hours after surgery	Recording of the filling solute volumes administered within 48 hours postoperatively
Duration of stay in the ward	Up to 28 days post surgery
Use of catecholamin	48 hours after surgery	Recording (YES/NO) of the recourse of catecholamin required during the medical care, within 48 hours postoperatively
Special extra corporeal circulation	48 hours after surgery	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.
Repeatability of the Nephrocheck® test	10 hours post surgery	Only for the patients in the Nephrocheck arm, variations between pre and postoperative Nephrocheck® test results will be assessed
Oliguria	48 hours after surgery	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 ;
Mortality rate	Up to 28 days post surgery	Mortality rate in the ward

Trial Locations

Locations (1)

Rennes University Hospital; 🇫🇷 Rennes, France