Can Nephrocheck™ Predict the Reversibility of Early, Acute Kidney Injury During Septic Shock?

NCT ID: NCT02812784

Last Updated: 2018-08-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 190 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-09-16
• Study Completion Date: 2018-08-31

Brief Summary

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.

Conditions

Heading

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Nephrocheck TM

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julien MAIZEL, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Locations

CHU Amiens

Amiens, , France

Site Status: RECRUITING

CH Avranches-Granville

Avranches, , France

Site Status: RECRUITING

CH Cahors

Cahors, , France

Site Status: RECRUITING

CH Dax

Dax, , France

Site Status: RECRUITING

CH Marc Jacquet

Melun, , France

Site Status: RECRUITING

CH de Mont-de-Marsan

Mont-de-Marsan, , France

Site Status: RECRUITING

CHU Montpellier

Montpellier, , France

Site Status: RECRUITING

CH Paris-Saint Joseph

Paris, , France

Site Status: RECRUITING

CHU Poitiers

Poitiers, , France

Site Status: RECRUITING

CHU Saint-Etienne

Saint-Etienne, , France

Site Status: RECRUITING

CH Salon-de-provence

Salon-de-Provence, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Julien MAIZEL, Md, PhD

Role: CONTACT

maizel.julien@chu-amiens.fr

+33 3 22 08 78 07

Facility Contacts

Julien MAIZEL, MD, PhD

Role: primary

maizel.julien@chu-amiens.fr

+33 3 22 08 78 07

Frédéric GODDE, PhD

Role: primary

Karim CHAOUKI, PhD

Role: primary

Maude ANDRIEU, PhD

Role: primary

Christophe VINSONNEAU

Role: primary

Michel PASCAL

Role: primary

Kada KLOUCHE

Role: primary

Benoît MISSET

Role: primary

René ROBERT, PhD

Role: primary

Christophe MARIAT, PhD

Role: primary

Hicham BAHLOUL, PhD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 32487237 (View on PubMed)

Other Identifiers

PI2015_843_0022

Identifier Type: -

Identifier Source: org_study_id