Acute Kidney Injury, Cardiac Surgery
Conditions
Keywords
Urinary biomarkers, Intensive Care Unit
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.
Interventions
PROCEDUREStandard clinical routine
Patient management is carried out according to the usual service protocol
PROCEDURENephrocheck 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.
Sponsors
JRAR Association
Rennes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
open labeled randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Duration of stay in the ward | Up to 28 days post surgery | — |
| Filling solute volumes | 48 hours after surgery | Recording of the filling solute volumes administered within 48 hours postoperatively |
| 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 |
| Mortality rate | Up to 28 days post surgery | Mortality rate in the ward |
| 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 ; |
Countries
France
Outcome results
None listed