Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT02034240
Recruitment Status : Completed
First Posted : January 13, 2014
Last Update Posted : April 21, 2015
Sponsor:
Collaborator:
Kolding Sygehus
Information provided by (Responsible Party):
Claes Falkenberg Elvander, Sygehus Lillebaelt

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT02034240


Locations
Layout table for location information
Denmark
Faelles Akut Modtagelse, Kolding Sygehus
Kolding, Denmark, 6000
Sponsors and Collaborators
Sygehus Lillebaelt
Kolding Sygehus
Investigators
Layout table for investigator information
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
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Claes Falkenberg Elvander, Medical Doctor, Sygehus Lillebaelt
ClinicalTrials.gov 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:
Layout table for MeSH terms
Sepsis
Acute Kidney Injury
Wounds and Injuries
Infection
Systemic Inflammatory Response Syndrome
 Inflammation
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases