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

NCT03547414 | Recruiting

• 1 other identifier: PI2018_843_0030
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury; Septic Shock

Outcome Measures

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

  72 hours

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens-Picardie

Amiens, 80054, France

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury; Shock, Septic

Condition Hierarchy (Ancestors)

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

Study Officials

• Julien Maizel

  CHU Amiens-Picardie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julien MAIZEL, PU-PH

CONTACT

+33 322087807; maizel.julien@chu-amiens.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: June 6, 2018
• Study Start: May 16, 2018
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: June 16, 2026

Record last verified: 2026-06

Locations

FR (1)