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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Université Victor Segalen Bordeaux 2.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Inverness Medical Innovations
Information provided by:
Université Victor Segalen Bordeaux 2
ClinicalTrials.gov Identifier:
NCT01122225
First received: May 10, 2010
Last updated: May 28, 2010
Last verified: April 2010

May 10, 2010
May 28, 2010
July 2009
May 2010   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01122225 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Neutrophile Gelatinase Associated Lipocalin Evaluation in Septic Acute Kidney Injury
Neutrophile Gelatinase Associated Lipocalin Evaluation in Septic Acute Kidney Injury

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.

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Blood Sample (350 µl) at inclusion and then 24 and 48 hours after

Non-Probability Sample

patients of a medical intensive care presenting with a septic shock

Acute Kidney Failure
Not Provided
Septic shock
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
June 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01122225
NESAKI08-267
No
Fabrice CAMOU, MD, University Hospital of Bordeaux
Université Victor Segalen Bordeaux 2
Inverness Medical Innovations
Principal Investigator: Fabrice Camou, MD Bordeaux University Hospital
Université Victor Segalen Bordeaux 2
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP