Can Timps2 and IGFBP7 Urine Test Help Flag High-Risk AKI in Septic Shock Patients
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
Run by Centre Hospitalier Universitaire, Amiens · NCT03547414 · Data updated 2026-11-12
This study tests whether a urine test called Nephrocheck, which measures TIMP2 and IGFBP7, can identify septic shock patients at higher risk of progressing to severe acute kidney injury.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Status | Recruiting |
| Started | May 16, 2018 |
| Main results expected | June 2026 |
| Study ends | June 2026 |
| Registry record updated | June 16, 2026 |
| Trial ID | NCT03547414 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older with septic shock and KDIGO stage 1 or higher AKI, seen within 4 hours of catecholamine initiation.
✕Probably not a fit
Patients without AKI progression risk or with conditions that limit interpretation of the biomarker may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In septic shock, acute kidney injury is common and can worsen to severe stages. This observational study reanalyzes data from previous septic shock cohorts to see if the Nephrocheck urine test can predict which patients will progress to KDIGO stage 3 AKI. The test measures two markers of kidney tubular injury in urine to help flag at-risk patients. Researchers will assess whether TIMP2 and IGFBP7 levels correlate with progression and potential need for renal replacement therapy. Results could guide earlier intervention and resource planning in ICUs.
Why it matters
Potential benefit: If successful, the test could help clinicians identify high-risk patients earlier and tailor treatment to prevent severe AKI.
How similar studies have gone: Previous studies in septic shock cohorts have validated TIMP2 and IGFBP7 as markers of kidney injury risk, supporting reanalysis in this observational context.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
CHU Amiens-Picardie
Amiens, France Recruiting
Study contacts
- Principal investigator: Julien Maizel — CHU Amiens-Picardie
- Study coordinator: Julien MAIZEL, PU-PH
- Email: maizel.julien@chu-amiens.fr
- Phone: +33 322087807
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.