Neutrophile Gelatinase Associated Lipocalin Evaluation in Septic Acute Kidney Injury

NCT ID: NCT01122225

Last Updated: 2010-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-06-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Acute Kidney Failure

Keywords

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septic shock medical intensive care

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Septic shock

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inverness Medical Innovations

INDUSTRY

Sponsor Role collaborator

Université Victor Segalen Bordeaux 2

OTHER

Sponsor Role lead

Responsible Party

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University Hospital of Bordeaux

Principal Investigators

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Fabrice Camou, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

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Reanimation medicale, Hopital Saint-Andre, Bordeaux University Hospital

Bordeaux, Aquitaine, France

Site Status

Countries

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France

Other Identifiers

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NESAKI08-267

Identifier Type: -

Identifier Source: org_study_id