Does Urinary TIMP2 and IGFBP7 Can Identify High Risk Patients of Progression From Mild and Moderate to Severe Acute Kidney Injury During Septic Shock?
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nephrocheck test.
- Who it may be relevant to
- Registry conditions: Acute Kidney Injury, Septic Shock. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Does Urinary TIMP2 and IGFBP7 Can Identify High Risk Patients of Progression From Mild and Moderate to Severe Acute Kidney Injury During Septic Shock? HEMOCHECK
Overview
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.
Interventions
- Other Nephrocheck test
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 uri
Primary outcome measures
- KDIGO classification [Time frame: 72 hours]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-only
Study locations
France · 1 center
- CHU Amiens-Picardie — Amiens
Publications
- Maizel J, Daubin D, Vong LV, Titeca-Beauport D, Wetzstein M, Kontar L, Slama M, Klouche K, Vinsonneau C. Urinary TIMP2 and IGFBP7 Identifies High Risk Patients of Short-Term Progression from Mild and Moderate to Severe Acute Kidney Injury during Septic Shock: A Prospective Cohort Study. Dis Markers. 2019 Apr 1;2019:3471215. doi: 10.1155/2019/3471215. eCollection 2019. PMID 31061681
Identifiers
NCT: NCT03547414 · PI2018_843_0030