Neutrophile Gelatinase Associated Lipocalin Evaluation in Septic Acute Kidney Injury

NCT01122225 | Unknown

• 1 other identifier: NESAKI08-267
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Failure

Keywords

septic shock; medical intensive care

Study Arms (1)

Septic shock

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients of a medical intensive care presenting with a septic shock

You may qualify if:

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

You may not qualify if:

• Age under 18 years
• Prisoners or other institutionalized or vulnerable individuals
• Participation in an interventional clinical study within the previous 30 days

Sponsors & Collaborators

• Université Victor Segalen Bordeaux 2: lead
• Inverness Medical Innovations: collaborator

Study Sites (1)

Reanimation medicale, Hopital Saint-Andre, Bordeaux University Hospital

Bordeaux, Aquitaine, 33000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Acute Kidney Injury; Shock, Septic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Fabrice Camou, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 10, 2010
• First Posted: May 13, 2010
• Study Start: July 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: June 1, 2010
• Last Updated: May 31, 2010

Record last verified: 2010-04

Locations

FR (1)