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

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.

Study Overview

• Status: Unknown
• Conditions: 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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• France
  • Aquitaine
    • Bordeaux, Aquitaine, France, 33000
      • Reanimation medicale, Hopital Saint-Andre, Bordeaux University Hospital

Participation Criteria

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 of a medical intensive care presenting with a septic shock

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Septic shock

Collaborators and Investigators

• Sponsor: Université Victor Segalen Bordeaux 2
• Collaborators: Inverness Medical Innovations
• Investigators: Principal Investigator: Fabrice Camou, MD, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): May 1, 2010
• Study Completion (Anticipated): June 1, 2010

Study Registration Dates

• First Submitted: May 10, 2010
• First Submitted That Met QC Criteria: May 10, 2010
• First Posted (Estimate): May 13, 2010

Study Record Updates

• Last Update Posted (Estimate): May 31, 2010
• Last Update Submitted That Met QC Criteria: May 28, 2010
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: septic shock; medical intensive care
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: NESAKI08-267