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)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Septic Shock; Acute Kidney Injury
• Intervention / Treatment: Other: Nephrocheck test

• Study Type: Observational
• Enrollment (Estimated): 110

Contacts and Locations

• Study Contact: Name: Julien Maizel, PU-PH; Phone Number: +33 322087807; Email: maizel.julien@chu-amiens.fr

Study Locations

• France
  • Amiens, France, 80054
    • Recruiting
    • CHU Amiens-Picardie
    • Contact: Julien Maizel, PU-PH; Phone Number: +33 322087807; Email: maizel.julien@chu-amiens.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Investigators: Principal Investigator: Julien Maizel, CHU Amiens-Picardie

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2018
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: May 17, 2018
• First Submitted That Met QC Criteria: June 4, 2018
• First Posted (Actual): June 6, 2018

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Renal Insufficiency; Shock; Pathological Conditions, Signs and Symptoms; Acute Kidney Injury; Shock, Septic
• Other Study ID Numbers: PI2018_843_0030

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No