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NCT Number: NCT03547414

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

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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Inflammation Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Sepsis Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nephrocheck test

Other

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.

Primary outcomes

  1. KDIGO classification

    Time frame: 72 hours

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

Study contacts

Contact information is provided by the study sponsor or research team.

Julien MAIZEL, PU-PH

CONTACT

[email protected]

+33 322087807

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study 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

Acronym: HEMOCHECK

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Jun 6, 2018
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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