Does Urinary TIMP2 and IGFBP7 Can Identify High Risk Patients of Progression From Mild and Moderate to Severe Acute Kidney Injury During Septic Shock?

• Conditions: Septic Shock; Acute Kidney Injury

• Registration Number: NCT03547414
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-17
• Status Verified: 2018-06
• Study First Submitted QC: 2018-06-04
• Last Update Submitted: 2018-06-04
• Study First Posted: 2018-06-06
• Last Update Posted: 2018-06-06
• Study Start: 2018-08-16
• Primary Completion: 2018-09-16
• Study Completion: 2018-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Age 18 or over
• Septic shock (according to Bone's criteria) within 4 hours of introduction of catecholamines
• AKI, characterized by a KDIGO score ≥ 1
• Social security coverage

Exclusion Criteria

• AKI requiring emergency RRT (in the critical care physician's opinion).
• Anuria
• Stage 4-5 chronic kidney failure with a GFR below 30 ml/min.
• Rapidly progressing renal disorders (glomerulonephritis, HUS, blockage, etc.)
• Obstructive AKI
• Probable glomerular damage (nephritic syndrome, nephrotic syndrome, chronic glomerulonephritis)
• Pregnancy or breastfeeding
• Legal guardianship or lack of social security coverage.
• Cardiocirculatory arrest
• Life expectancy <48 hours.
• Child C cirrhosis
• Prior occurrence of AKI during the current hospital stay
• Transplantation
• Subject participating in another study with an exclusion period ongoing at the time of the pre-inclusion

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
KDIGO classification	72 hours	predictive value of Nephrocheck™ with regard to the worsening of AKI, defined as severe AKI (KDIGO 3) in 72 hours following inclusion