Acute Kidney Injury After Cardiac Surgery (NEPHROCAR)
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|ClinicalTrials.gov Identifier: NCT03396770|
Recruitment Status : Recruiting
First Posted : January 11, 2018
Last Update Posted : December 17, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Kidney Injury Cardiac Surgery||Procedure: Standard clinical routine Procedure: Nephrocheck test||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||850 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||open labeled randomized clinical trial|
|Masking:||None (Open Label)|
|Official Title:||Impact of the Early Hemodynamic Evaluation Guided by Urinary Biomarkers on the Acute Kidney Injury After Cardiac Surgery|
|Actual Study Start Date :||January 14, 2018|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||May 2020|
Active Comparator: Control group
Standard clinical routine
Procedure: Standard clinical routine
Patient management is carried out according to the usual service protocol
Experimental: Nephrocheck group
Procedure: Nephrocheck test
Nephrocheck® test is realized 4 hours after the end of the cardiopulmonary bypass
- Occurence of an AKI according to the KDIGO classification without oliguria [ Time Frame: 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
- Filling solute volumes [ Time Frame: 48 hours after surgery ]Recording of the filling solute volumes administered within 48 hours postoperatively
- Use of catecholamin [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 28 days post surgery ]
- Oliguria [ Time Frame: 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 ;
- Repeatability of the Nephrocheck® test [ Time Frame: 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 [ Time Frame: Up to 28 days post surgery ]Mortality rate in the ward
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03396770
|Contact: Sébastien BIEDERMANN, MDfirstname.lastname@example.org|
|Rennes University Hospital||Recruiting|
|Rennes, France, 35000|
|Contact: Sebastien BIEDERMANN, MD email@example.com|
|Principal Investigator:||Sébastien BIEDERMANN, MD||CHU Rennes|