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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03547414
Recruitment Status : Not yet recruiting
First Posted : June 6, 2018
Last Update Posted : June 6, 2018
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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.

Condition or disease Intervention/treatment
Acute Kidney Injury Septic Shock Other: Nephrocheck test

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Study Type : Observational
Estimated Enrollment : 110 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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
Estimated Study Start Date : August 16, 2018
Estimated Primary Completion Date : September 16, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Intervention Details:
  • 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.

Primary Outcome Measures :
  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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with Septic shock (according to Bone's criteria) within 6 hours of introduction of catecholamines

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03547414

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Contact: Julien MAIZEL, Professor 03-22-08-78-07

Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Centre Hospitalier Universitaire, Amiens Identifier: NCT03547414     History of Changes
Other Study ID Numbers: PI2018_843_0030
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Shock, Septic
Pathologic Processes
Urologic Diseases
Systemic Inflammatory Response Syndrome
Tissue Inhibitor of Metalloproteinase-2
TIMP2 protein, human
Matrix Metalloproteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action