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Neutrophil Gelatinase Associated Lipocalin (NGAL) in Urine: Can This Prove to be a Biomarker for Acute Kidney Injury in Patients With Sepsis?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02034240
Recruitment Status : Completed
First Posted : January 13, 2014
Last Update Posted : April 21, 2015
Kolding Sygehus
Information provided by (Responsible Party):
Claes Falkenberg Elvander, Sygehus Lillebaelt

Brief Summary:
Patients with severe infection and sepsis are in high risk of hypo perfusion and therefore organ affection. Temporary or permanent kidney failure is a common complication in these patients. Today's golden standard for kidney failure detection is creatinine levels rising and / or oliguria. The investigators hypothesize that an even more sensitive biomarker; neutrophil gelatinase associated lipocalin(NGAL) in urine can predict kidney injury before creatinine levels rise. In recent studies NGAL in urine seem to be a sensitive biomarker in these patient to predict kidney injury, but the time factor for sampling optimally is not known. In this pilot study the investigators sample the urine at admission within the first hour of hospitalization to investigate if NGAL can be used as a predictor in an emergency setting.

Condition or disease
Severe Sepsis Septic Shock Acute Kidney Injury

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Study Type : Observational [Patient Registry]
Actual Enrollment : 21 participants
Target Follow-Up Duration: 5 Weeks
Official Title: Secretion of Neutrophil Gelatinase Associated Lipocalin in Septic Patients and the Development of Acute Kidney Injury
Study Start Date : January 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Primary Outcome Measures :
  1. Development of Acute Kidney Failure [ Time Frame: During hospitalization, anticipated approximately 5 weeks ]

Secondary Outcome Measures :
  1. Levels of NGAL in patients with kidney failure compared to creatinine [ Time Frame: During hospitalization, anticipated approximately 5 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with no prior record of kidney failure

Inclusion Criteria:

  • Severe sepsis
  • Septic shock
  • Patients must not be able to give consent

Exclusion Criteria:

  • Underaged (18 years )
  • known kidney injury
  • Fully alert patients that can give consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02034240

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Faelles Akut Modtagelse, Kolding Sygehus
Kolding, Denmark, 6000
Sponsors and Collaborators
Sygehus Lillebaelt
Kolding Sygehus
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Study Chair: Jannie Bisgaard Stæhr, PhD, M.D Odense University Hospital
Study Director: Claes Falkenberg Elvander, M.D Kolding Sygehus
Principal Investigator: Srishamanthi Sriskandarajah, M.D Kolding Sygehus
Additional Information:

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Responsible Party: Claes Falkenberg Elvander, Medical Doctor, Sygehus Lillebaelt Identifier: NCT02034240    
Other Study ID Numbers: DNVK:1305 385
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Acute Kidney Injury
Wounds and Injuries
Systemic Inflammatory Response Syndrome
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases