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Neutrophile Gelatinase Associated Lipocalin Evaluation in Septic Acute Kidney Injury (NESAKI)

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ClinicalTrials.gov Identifier: NCT01122225
Recruitment Status : Unknown
Verified April 2010 by Université Victor Segalen Bordeaux 2.
Recruitment status was:  Active, not recruiting
First Posted : May 13, 2010
Last Update Posted : May 31, 2010
Sponsor:
Collaborator:
Inverness Medical Innovations
Information provided by:
Université Victor Segalen Bordeaux 2

Study Description
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Brief Summary:

Acute kidney injury (AKI) is a major organ failure in septic shock. Current medical tests (serum creatinine and urea) cannot identify AKI until approximately 48 hours after it occurs. Neutrophil gelatinase-associated lipocalin (NGAL) may be able to predict ischemic AKI more effectively and faster than serum creatinine and urea levels.

The purpose of this study is to take a blood sample from patients at admission and then at 24 and 48 hours after to test their plasma for NGAL and compare the NGAL levels to their creatinine and urea levels. The investigators hypothesize that NGAL is an earlier marker to classify the kidney failure as acute tubular necrosis or pre-renal azotemia than creatinine and urea.


Condition or disease
Acute Kidney Failure

Detailed Description:

Primary Outcome Measures:

To correlate elevated serum NGAL with the diagnosis of intrinsic acute kidney injury in septic shock

Secondary Outcome Measures :

To compare serum NGAL with serum creatinine, serum urea and urine output in septic AKI Death within the intensive care unit Death from all causes at 28 days after inclusion

Study Design
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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neutrophile Gelatinase Associated Lipocalin Evaluation in Septic Acute Kidney Injury
Study Start Date : July 2009
Actual Primary Completion Date : May 2010
Estimated Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Groups and Cohorts
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Group/Cohort
Septic shock


Outcome Measures
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Biospecimen Retention:   Samples Without DNA
Blood Sample (350 µl) at inclusion and then 24 and 48 hours after

Eligibility Criteria
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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 of a medical intensive care presenting with a septic shock
Criteria

Inclusion Criteria:

  • Patients showing signs of infection and hypotension requiring the use of epinephrine despite of an appropriate fluid challenge.
  • 18 years of age or older

Exclusion Criteria:

  • Age under 18 years
  • Prisoners or other institutionalized or vulnerable individuals
  • Participation in an interventional clinical study within the previous 30 days
Contacts and Locations
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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): NCT01122225


Locations
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France
Reanimation medicale, Hopital Saint-Andre, Bordeaux University Hospital
Bordeaux, Aquitaine, France, 33000
Sponsors and Collaborators
Université Victor Segalen Bordeaux 2
Inverness Medical Innovations
Investigators
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Principal Investigator: Fabrice Camou, MD University Hospital, Bordeaux
More Information
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Responsible Party: Fabrice CAMOU, MD, University Hospital of Bordeaux
ClinicalTrials.gov Identifier: NCT01122225    
Other Study ID Numbers: NESAKI08-267
First Posted: May 13, 2010    Key Record Dates
Last Update Posted: May 31, 2010
Last Verified: April 2010
Keywords provided by Université Victor Segalen Bordeaux 2:
septic shock
medical intensive care
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases