HeadingAKI-CHECKNCT02812784
Can Nephrocheck™ Predict the Reversibility of Early, Acute Kidney Injury During Septic Shock?
An observational study of Heading, run by Centre Hospitalier Universitaire, Amiens at 11 sites in France.
Trial summary
Patients with septic shock in the intensive care unit have an elevated risk of developing acute kidney injury (AKI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heading
- What is being tested?
- Nephrocheck TM
- Type of treatment
- Medical device
- How many people
- 184 participants
- Where
- 11 sitesFrance
- Study dates
- 16 Sep 2015to 11 Feb 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: patients with Septic shock (according to Bone's criteria) within 4 hours of introduction of catecholamines
Who may be able to join
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
CHU Amiens
Amiens, 80054
CH Avranches-Granville
Avranches, 50300
CH Cahors
Cahors, 46000
CH Dax
Dax, 40100
CH Marc Jacquet
Melun, 77000
CH de Mont-de-Marsan
Mont-de-Marsan, 40000
CHU Montpellier
Montpellier, 34172
CH Paris-Saint Joseph
Paris, 75
CHU Poitiers
Poitiers, 86000
CHU Saint-Etienne
Saint-Etienne, 42000
CH Salon-de-provence
Salon-de-Provence, 13300
About this study
Patients with septic shock in the intensive care unit have an elevated risk of developing acute kidney injury (AKI).
Read the detailed description
Patients with septic shock in the intensive care unit have an elevated risk of developing acute kidney injury (AKI). AKI is an independent factor for mortality. Interventions that limit the worsening of renal function might have an impact on the mortality rate in these patients. 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 hemodynamic change during the initial phase 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.
- Conditions
- Heading
- Being tested
- Nephrocheck TM
- Keywords
- Nephrocheck™, acute kidney injury
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nephrocheck TMDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
KDIGO classification
predictive value of Nephrocheck™ with regard to the reversibility of AKI, defined as the recovery of normal renal function (KDIGO 0) in the 72 hours following inclusion
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study start16 Sep 2015
- Primary completion11 Feb 2019
- Study completion11 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HeadingStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien MAIZEL, MD, PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812784
- Sponsor's protocol ID
- PI2015_843_0022
- Acronym
- AKI-CHECK
- Status last verified
- Jun 2026
- First submitted
- 20 Jun 2016
- Last updated
- 12 Jun 2026
- Results posted
- No
Publications
Titeca-Beauport D, Daubin D, Van Vong L, Belliard G, Bruel C, Alaya S, Chaoui K, Andrieu M, Rouquette-Vincenti I, Godde F, Pascal M, Diouf M, Vinsonneau C, Klouche K, Maizel J. Urine cell cycle arrest biomarkers distinguish poorly between transient and persistent AKI in early septic shock: a prospective, multicenter study. Crit Care. 2020 Jun 1;24(1):280. doi: 10.1186/s13054-020-02984-6.
PubMed 32487237
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Nephrocheck™ Predict the Reversibility of Early, Acute Kidney Injury During Septic Shock?
- ClinicalTrials.gov ID
- NCT02812784
- Acronym / sponsor ID
- AKI-CHECK / PI2015_843_0022
- Conditions
- Heading
- Keywords
- Nephrocheck™, acute kidney injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 16 Sep 2015 (actual)
- Primary completion
- 11 Feb 2019 (actual)
- Study completion
- 11 Feb 2019 (actual)
- First posted
- 24 Jun 2016 (estimated)
- 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 an elevated risk of developing acute kidney injury (AKI).
Detailed description
Patients with septic shock in the intensive care unit have an elevated risk of developing acute kidney injury (AKI). AKI is an independent factor for mortality. Interventions that limit the worsening of renal function might have an impact on the mortality rate in these patients. 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 hemodynamic change during the initial phase 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with Septic shock (according to Bone's criteria) within 4 hours of introduction of catecholamines
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nephrocheck TM | Device | – |
Primary outcome
KDIGO classification
Time frame: 72 hours
predictive value of Nephrocheck™ with regard to the reversibility of AKI, defined as the recovery of normal renal function (KDIGO 0) in the 72 hours following inclusion
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 12 Jun 2026.
- Derived from this study: PubMed 32487237Titeca-Beauport D, Daubin D, Van Vong L, Belliard G, Bruel C, Alaya S, Chaoui K, Andrieu M, Rouquette-Vincenti I, Godde F, Pascal M, Diouf M, Vinsonneau C, Klouche K, Maizel J. Urine cell cycle arrest biomarkers distinguish poorly between transient and persistent AKI in early septic shock: a prospective, multicenter study. Crit Care. 2020 Jun 1;24(1):280. doi: 10.1186/s13054-020-02984-6.
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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.
Julien MAIZEL, MD, PhD principal investigator
CHU Amiens
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heading, run by Centre Hospitalier Universitaire, Amiens at 11 sites 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 4 inclusion and 14 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 12 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 11 sites 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 classification (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02812784, which also lists 1 linked publication.
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 12 Jun 2026.