CompletedNot Applicable

TIMP2*IGFBP7 and Transient AKI

France77 participantsStarted 2018-11-05

Plain-language summary

Patients with septic shock in the intensive care unit have a high risk to develop acute kidney injury (AKI) and AKI is an independent risk factor of mortality. Given the absence of validated pharmacological treatments for limiting the progression of AKI or for accelerating recovery from AKI, early intervention and the restoration of the glomerular filtration rate (GFR) in this context of septic shock might improve the patients' prognosis. One major challenge is to determine whether or not the AKI is reversible (return to normal function KDIGO 0 within 72 hours). In this retrospective study the investigators will analyze all patients admitted for a septic shock in three French ICUs between the 1st january 2014 and 01st January 2017 who developed an AKI (KDIGO ≥1) at admission and who had a determination of the urine concentration of TIMP2\*IGFBP7 at admission. The investigators will determine the best threshold of TIMP2\*IGFBP7 to distinguish the population of patients who will return to normal kidney function within 72 hours (KDIGO 0).

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 * Inclusion criteria: septic shock (according to Bone's criteria) within 4 hours following the introduction of catecholamines, AKI defined by KDIGO≥1, social security coverage, measurement of the urine concentration of TIMP2\*IGFBP7 within the 4 hours following the introduction of catecholamines, patients admitted for a septic shock between 1st January 2014 and 1st January 2017 in the medical ICU of Amiens university hospital France, medical ICU of Montpellier university hospital France and ICU Melun hospital, France Exclusion Criteria: * Need for immediate renal replacement therapy, anuria, chronic renal failure (stage 4 or 5 with GFR\<30ml/min), obstructive AKI, pregnancy, cardiac arrest during the same hospitalization, life expectancy\<48 hours, Child C Cirrhosis, prior occurrence of AKI during the current hospital stay, kidney transplantation.

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 a biomarker called TIMP2*IGFBP7 to assess kidney injury risk in septic shock — can you explain what this biomarker actually measures and whether testing it would change how my kidneys are monitored or treated?
2The trial is measuring something called a KDIGO value, which I understand is a scoring system for acute kidney injury — can you help me understand what KDIGO stages mean for someone with septic shock, and how bad kidney injury typically affects recovery?
3Since this trial doesn't have a listed phase, it sounds like it may be more of an observational or diagnostic study rather than a treatment study — does that mean participating wouldn't change what treatments I receive, and what exactly would be asked of me if I were involved?
4Given that septic shock is a medical emergency requiring fast decisions, how realistic is it to discuss trial participation in this kind of situation, and who would make that decision if I'm not able to speak for myself?
5Are there standard monitoring approaches already used in your practice for detecting early kidney injury in septic shock patients, and how does what this trial is studying compare to what you would normally do for my care?

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.

What they're measuring

KDIGO value

Timeframe: return to KDIGO 0 within the first 72 hours following the introduction of catecholamines

Trial details

NCT IDNCT03472079

SponsorCentre Hospitalier Universitaire, Amiens

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-11-05

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