Neutrophile Gelatinase Associated Lipocalin Evaluation in Septic Acute Kidney Injury

Acute Kidney Failure Clinical Trial

— NESAKI  

Official title:

Neutrophile Gelatinase Associated Lipocalin Evaluation in Septic Acute Kidney Injury

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01122225
• Other study ID #: NESAKI08-267
• Status: Active, not recruiting
• Phase: N/A
• First received: May 10, 2010
• Last updated: May 28, 2010
• Start date: July 2009
• Est. completion date: June 2010

Study information

• Verified date: April 2010
• Source: Université Victor Segalen Bordeaux 2
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: June 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Kidney Failure
• Acute Kidney Injury
• Renal Insufficiency

Locations

Country	Name	City	State
France	Reanimation medicale, Hopital Saint-Andre, Bordeaux University Hospital	Bordeaux	Aquitaine

Sponsors (2)

Lead Sponsor	Collaborator
Université Victor Segalen Bordeaux 2	Inverness Medical Innovations

Country where clinical trial is conducted

France,