Does Urinary TIMP2 and IGFBP7 Can Identify High Risk Patients of Progression From Mild and Modera… (NCT03547414) | Clinical Trial Compass
RecruitingNot Applicable
Does Urinary TIMP2 and IGFBP7 Can Identify High Risk Patients of Progression From Mild and Moderate to Severe Acute Kidney Injury During Septic Shock?
France110 participantsStarted 2018-05-16
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying urine biomarkers called TIMP2 and IGFBP7 to predict which patients with septic shock might get worse kidney injury — how would my urine actually be tested, and would those results change any treatment decisions for me in real time?
2Since this study is classified as 'NA' for phase, it seems more focused on observation and measurement than testing a new treatment — does participating mean I would receive any different care than I'd get with standard septic shock and kidney injury management?
3The trial uses the KDIGO classification to track kidney injury severity — can you explain what stage of kidney injury I'm currently at under that system, and how monitoring my progression fits into my overall care plan?
4Because this appears to be an observational study collecting biomarker data, what are the risks or burdens involved for me, such as how often urine samples would be collected and whether that affects anything else being done for my treatment?
5Are there standard tools or tests already being used in your practice to monitor kidney injury during septic shock, and how does joining this study compare to what I'd experience if I didn't participate?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.