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Trial record 7 of 32 for:    shock | Recruiting, Not yet recruiting, Available Studies | Acute kidney injury

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

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ClinicalTrials.gov Identifier: NCT02812784
Recruitment Status : Recruiting
First Posted : June 24, 2016
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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

Condition or disease Intervention/treatment
Heading Device: Nephrocheck TM

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.

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Study Type : Observational
Estimated Enrollment : 190 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Can Nephrocheck™ Predict the Reversibility of Early, Acute Kidney Injury During Septic Shock?
Actual Study Start Date : September 16, 2015
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock




Primary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples Without DNA
urine blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with Septic shock (according to Bone's criteria) within 4 hours of introduction of catecholamines
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812784


Contacts
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Contact: Julien MAIZEL, Md, PhD +33 3 22 08 78 07 maizel.julien@chu-amiens.fr

Locations
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France
CHU Amiens Recruiting
Amiens, France, 80054
Contact: Julien MAIZEL, MD, PhD    +33 3 22 08 78 07    maizel.julien@chu-amiens.fr   
CH Avranches-Granville Recruiting
Avranches, France, 50300
Contact: Frédéric GODDE, PhD         
CH Cahors Recruiting
Cahors, France, 46000
Contact: Karim CHAOUKI, PhD         
CH Dax Recruiting
Dax, France, 40100
Contact: Maude ANDRIEU, PhD         
CH Marc Jacquet Recruiting
Melun, France, 77000
Contact: Christophe VINSONNEAU         
CH de Mont-de-Marsan Recruiting
Mont-de-Marsan, France, 40000
Contact: Michel PASCAL         
CHU Montpellier Recruiting
Montpellier, France, 34172
Contact: Kada KLOUCHE         
CH Paris-Saint Joseph Recruiting
Paris, France, 75
Contact: Benoît MISSET         
CHU Poitiers Recruiting
Poitiers, France, 86000
Contact: René ROBERT, PhD         
CHU Saint-Etienne Recruiting
Saint-Etienne, France, 42000
Contact: Christophe MARIAT, PhD         
CH Salon-de-provence Recruiting
Salon-de-provence, France, 13300
Contact: Hicham BAHLOUL, PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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Principal Investigator: Julien MAIZEL, MD, PhD CHU Amiens

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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT02812784     History of Changes
Other Study ID Numbers: PI2015_843_0022
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Keywords provided by Centre Hospitalier Universitaire, Amiens:
Nephrocheck™
acute kidney injury
Additional relevant MeSH terms:
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Shock, Septic
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Shock
Urologic Diseases
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes