Septic ShockBIOCHECKNCT03472079
TIMP2*IGFBP7 and Transient AKI
An observational study of Septic Shock, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- How many people
- 77 participants
- Where
- 1 siteFrance
- Study dates
- 5 Nov 2018to 5 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: univariate comparison between the 2 groups (transient and persistent AKI) using Mann Whithney test or Chi square test. ROC curve analysis to determine the best threshold of TIMP2*IGFBP7 groups to distinguish the 2 groups.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Conditions
- Septic Shock
- Keywords
- Acute kidney injury, Septic shock, TIMP2*IGFBP7
- Medical subject headings
- Shock, Septic, Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
KDIGO value
: Transient AKI defined by the return to KDIGO 0 within the first 72 hours following the introduction of catecholamines
Measured: return to KDIGO 0 within the first 72 hours following the introduction of catecholamines
Secondary outcomes (1)
need for renal replacement therapy
need for renal replacement therapy within the first 72 hours following the introduction of catecholamines
Measured: within the first 72 hours following the introduction of catecholamines
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start5 Nov 2018
- Primary completion5 Nov 2019
- Study completion5 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03472079
- Sponsor's protocol ID
- PI2018_843_0013
- Acronym
- BIOCHECK
- Status last verified
- Jun 2026
- First submitted
- 14 Mar 2018
- Last updated
- 25 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03472079
- Acronym / sponsor ID
- BIOCHECK / PI2018_843_0013
- Conditions
- Septic Shock
- Keywords
- Acute kidney injury, Septic shock, TIMP2*IGFBP7
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 5 Nov 2019 (actual)
- Study completion
- 5 Nov 2019 (actual)
- First posted
- 21 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- univariate comparison between the 2 groups (transient and persistent AKI) using Mann Whithney test or Chi square test. ROC curve analysis to determine the best threshold of TIMP2*IGFBP7 groups to distinguish the 2 groups.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
need for renal replacement therapy
Time frame: within the first 72 hours following the introduction of catecholamines
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
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Hemodynamic Resuscitation Guided by Non-Invasive Mean Systemic Filling Pressure to Prevent Acute Kidney Injury in Septic Shock
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KDIGO value (time frame: return to KDIGO 0 within the first 72 hours following the introduction of catecholamines). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.