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

Heading Clinical Trial

— AKI-CHECK  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02812784
• Other study ID #: PI2015_843_0022
• Status: Recruiting
• Start date: September 16, 2015
• Est. completion date: August 2018

Study information

• Verified date: August 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Julien MAIZEL, Md, PhD
• Phone: +33 3 22 08 78 07
• Email: maizel.julien[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patients with septic shock in the intensive care unit have an elevated risk of developing acute kidney injury (AKI).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Heading
• Shock, Septic

Intervention

Device:
• Nephrocheck TM

Locations

Country	Name	City	State
France	CHU Amiens	Amiens
France	CH Avranches-Granville	Avranches
France	CH Cahors	Cahors
France	CH Dax	Dax
France	CH Marc Jacquet	Melun
France	CH de Mont-de-Marsan	Mont-de-Marsan
France	CHU Montpellier	Montpellier
France	CH Paris-Saint Joseph	Paris
France	CHU Poitiers	Poitiers
France	CHU Saint-Etienne	Saint-Etienne
France	CH Salon-de-provence	Salon-de-provence

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	72 hours