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

Acute Kidney Injury Clinical Trial

— HEMOCHECK  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03547414
• Other study ID #: PI2018_843_0030
• Status: Not yet recruiting
• Start date: August 16, 2018
• Est. completion date: December 30, 2018

Study information

• Verified date: June 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Julien MAIZEL, Professor
• Phone: 03-22-08-78-07
• Email: maizel.julien[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: December 30, 2018
• Est. primary completion date: September 16, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Septic Shock
• Shock
• Shock, Septic
• Wounds and Injuries

Intervention

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 urine mixed with 100 µl of buffer. The result is expressed as a single number corresponding to the product of TIMP2 and IGFBP7 concentrations.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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