Can Nephrocheck™ Predict the Reversibility of Early, Acute Kidney Injury During Septic Shock? (AKI-CHECK)

August 20, 2018 updated by: Centre Hospitalier Universitaire, Amiens
Patients with septic shock in the intensive care unit have an elevated risk of developing acute kidney injury (AKI).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

190

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
      • Avranches, France, 50300
        • Recruiting
        • CH Avranches-Granville
        • Contact:
          • Frédéric GODDE, PhD
      • Cahors, France, 46000
        • Recruiting
        • CH Cahors
        • Contact:
          • Karim CHAOUKI, PhD
      • Dax, France, 40100
        • Recruiting
        • CH Dax
        • Contact:
          • Maude ANDRIEU, PhD
      • Melun, France, 77000
        • Recruiting
        • CH Marc Jacquet
        • Contact:
          • Christophe VINSONNEAU
      • Mont-de-Marsan, France, 40000
        • Recruiting
        • CH de Mont-de-Marsan
        • Contact:
          • Michel PASCAL
      • Montpellier, France, 34172
        • Recruiting
        • CHU Montpellier
        • Contact:
          • Kada KLOUCHE
      • Paris, France, 75
        • Recruiting
        • CH Paris-Saint Joseph
        • Contact:
          • Benoît MISSET
      • Poitiers, France, 86000
        • Recruiting
        • CHU Poitiers
        • Contact:
          • René ROBERT, PhD
      • Saint-Etienne, France, 42000
        • Recruiting
        • Chu Saint-Etienne
        • Contact:
          • Christophe MARIAT, PhD
      • Salon-de-provence, France, 13300
        • Recruiting
        • CH Salon-de-provence
        • Contact:
          • Hicham BAHLOUL, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with Septic shock (according to Bone's criteria) within 4 hours of introduction of catecholamines

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Investigators

  • Principal Investigator: Julien MAIZEL, MD, PhD, CHU Amiens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 16, 2015

Primary Completion (ANTICIPATED)

August 1, 2018

Study Completion (ANTICIPATED)

August 1, 2018

Study Registration Dates

First Submitted

June 20, 2016

First Submitted That Met QC Criteria

June 22, 2016

First Posted (ESTIMATE)

June 24, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 21, 2018

Last Update Submitted That Met QC Criteria

August 20, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2015_843_0022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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