Neutrophile Gelatinase Associated Lipocalin Evaluation in Septic Acute Kidney Injury (NESAKI)
Recruitment status was Active, not recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | May 10, 2010 | ||||
| Last Updated Date | May 28, 2010 | ||||
| Start Date ICMJE | July 2009 | ||||
| Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01122225 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Neutrophile Gelatinase Associated Lipocalin Evaluation in Septic Acute Kidney Injury | ||||
| Official Title ICMJE | Neutrophile Gelatinase Associated Lipocalin Evaluation in Septic Acute Kidney Injury | ||||
| 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. |
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| 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 |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: Blood Sample (350 µl) at inclusion and then 24 and 48 hours after |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | patients of a medical intensive care presenting with a septic shock |
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| Condition ICMJE | Acute Kidney Failure | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Septic shock | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 50 | ||||
| Estimated Completion Date | June 2010 | ||||
| Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01122225 | ||||
| Other Study ID Numbers ICMJE | NESAKI08-267 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Fabrice CAMOU, MD, University Hospital of Bordeaux | ||||
| Study Sponsor ICMJE | Université Victor Segalen Bordeaux 2 | ||||
| Collaborators ICMJE | Inverness Medical Innovations | ||||
| Investigators ICMJE |
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| Information Provided By | Université Victor Segalen Bordeaux 2 | ||||
| Verification Date | April 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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