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TIMP2*IGFBP7 and Transient AKI

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03472079
Acronym
BIOCHECK
Enrollment
77
Registered
2018-03-21
Start date
2018-11-05
Completion date
2019-11-05
Last updated
2026-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock

Keywords

Acute kidney injury, Septic shock, TIMP2*IGFBP7

Brief 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).

Detailed description

Background : 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.

Interventions

None listed

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
KDIGO valuereturn 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

Secondary

MeasureTime frameDescription
need for renal replacement therapywithin the first 72 hours following the introduction of catecholaminesneed for renal replacement therapy within the first 72 hours following the introduction of catecholamines

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 26, 2026