TIMP2*IGFBP7 and Transient AKI (BIOCHECK)
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|ClinicalTrials.gov Identifier: NCT03472079|
Recruitment Status : Recruiting
First Posted : March 21, 2018
Last Update Posted : February 4, 2019
|Condition or disease|
Patients with septic shock in the intensive care unit have a high risk to develop acute kidney injury (AKI). 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 therefore how to determine whether or not the AKI is reversible. The best-studied biomarkers (NGAL and KIM 1) have little discriminant power in septic patients because of their poor specificity or unsuitable kinetics for very early diagnosis. The combination of urine assays for tissue inhibitor of metalloproteinase 2 (TIMP2) and insulin-like growth factor binding protein 7 (IGFBP7) has shown good diagnostic performance for the very early detection of the risk of developing AKI in the following 12 hrs. Urine levels of these two markers specifically reflect damage to kidney tubules. Moreover, the levels appear to be strongly correlated with the severity of tubule damage. Thus, one can reasonably hypothesize that measurement of these markers in the very early stages of septic shock might determine the presence and severity of kidney tubule damage. A threshold (yet to be defined) would help to differentiate between (i) transient, non-severe injury and (ii) injury that is already too severe to be reversible.
Purpose : to determine whether or not the urine concentration of TIMP2*IGFBP7 may distinguish patients with high risk of persistent or transient AKI during the early phase of septic shock.
|Study Type :||Observational|
|Estimated Enrollment :||170 participants|
|Official Title:||Does the Urine Concentration of TIMP2*IGFBP7 Can Distinguish Patients Who Will Present Transient or Persistent Acute Kidney Injury During Septic Shock? A Retrospective Analysis. BIOCHECK|
|Actual Study Start Date :||May 1, 2017|
|Estimated Primary Completion Date :||July 1, 2019|
|Estimated Study Completion Date :||August 1, 2019|
- KDIGO value [ Time Frame: return to KDIGO 0 within the first 72 hours following the introduction of catecholamines ]: Transient AKI defined by the return to KDIGO 0 within the first 72 hours following the introduction of catecholamines
- need for renal replacement therapy [ Time Frame: within the first 72 hours following the introduction of catecholamines ]need for renal replacement therapy within the first 72 hours following the introduction of catecholamines
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 ClinicalTrials.gov identifier (NCT number): NCT03472079
|Contact: Julien Maizel, Pr||+33 3 22 08 78 email@example.com|
|Amiens, France, 80000|
|Contact: Julien Maizel, Professor +33 3 22 08 78 07 firstname.lastname@example.org|