This trial is active, not recruiting.

Condition acute kidney failure
Sponsor Université Victor Segalen Bordeaux 2
Collaborator Inverness Medical Innovations
Start date July 2009
End date May 2010
Trial size 50 participants
Trial identifier NCT01122225, NESAKI08-267


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Neutrophile Gelatinase Associated Lipocalin Evaluation in Septic Acute Kidney Injury
Principal investigator Fabrice Camou, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in May 2010.
Information provided to ClinicalTrials.gov by Université Victor Segalen Bordeaux 2.