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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire, Amiens

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.)

Trial population

Patients with Septic shock (according to Bone's criteria) within 6 hours of introduction of catecholamines

Trial design

Design model

Case-only

Time perspective

Retrospective

Treatments tested in this trial

  • Nephrocheck test

    Other intervention

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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