An observational study in Acute Kidney Injury and Septic Shock, sponsored by Centre Hospitalier Universitaire, Amiens. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by Centre Hospitalier Universitaire, Amiens · Observational
Septic shock is one of the leading causes of death in patients admitted to the intensive care unit (ICU). Acute kidney injury (AKI) occurs in almost 50% of septic patients and is associated with significant mortality. Progression to the last stage (KDIGO stage 3) of AKI is an important step in the disease, as it usually requires initiation of RRT. Renal biomarkers are unable to accurately identify those patients who will progress to severe AKI (KDIGO 3). However, identification of patients at risk of progression to severe AKI could help the clinician to initiate optimal therapy including RRT. A new urine test, the Nephrocheck™ corresponding to the product of the urinary concentrations of 2 markers of renal tubule injury (TIMP2 and IGFBP7) has been validated. The Investigator have already performed two previous studies including septic shock patients (AKICHECK and BIOOCHECK). those previous datas will be reanalysed to examine whether the new urinary biomarkers TIMP2 and IGFBP7 can predict progression within 24 hours and 72 hours from mild and moderate (KDIGO 1 or 2) to severe AKI (KDIGO 3) in patients with septic shock.
-All the datas required will be collected from two previous studies (AKICHECK and BIOCHECK) performed in 3 centers: Amiens medical ICU, Melun medico surgical ICU and Montpellier Medical ICU.
1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.
This study's planned enrollment of 110 is below the median of 150 across 773 observational studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with Septic shock (according to Bone's criteria) within 6 hours of introduction of catecholamines
Exclusion Criteria:
A fresh urine sample was collected on inclusion (maximum 6 hours after starting catecholamines) through the urine collecting tube and frozen at -80°C. At the end of the study, urine samples were thawed and centrifuged as recommended by the manufacturer and the urinary TIMP2\*IGFBP7 concentration was determined using the Nephrocheck™ test. The Nephrocheck™ test simultaneously measures into the Astute 140™ meter (a bench top analyzer) the urinary concentrations of TIMP2 and IGFBP7 on 100 µl of urine mixed with 100 µl of buffer. The result is expressed as a single number corresponding to the product of TIMP2 and IGFBP7 concentrations.
KDIGO classification
predictive value of Nephrocheck™ with regard to the worsening of AKI, defined as severe AKI (KDIGO 3) in 72 hours following inclusion
Time frame: 72 hours
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Centre Hospitalier Universitaire, Amiens