Back to resultsNeutrophil Gelatinase Associated Lipocalin (NGAL) in Urine: Can This Prove to be a Biomarker for Acute Kidney Injury in Patients With Sepsis?
Primary Purpose
Severe Sepsis, Septic Shock, Acute Kidney Injury
Status
Completed
Phase
Locations
Denmark
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Severe Sepsis
Eligibility 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
Sites / Locations
- Faelles Akut Modtagelse, Kolding Sygehus
Outcomes
Primary Outcome Measures
Development of Acute Kidney Failure
Secondary Outcome Measures
Levels of NGAL in patients with kidney failure compared to creatinine
Full Information
NCT ID
NCT02034240
First Posted
January 7, 2014
Last Updated
April 19, 2015
Sponsor
Sygehus Lillebaelt
Collaborators
Kolding Sygehus
1. Study Identification
Unique Protocol Identification Number
NCT02034240
Brief Title
Neutrophil Gelatinase Associated Lipocalin (NGAL) in Urine: Can This Prove to be a Biomarker for Acute Kidney Injury in Patients With Sepsis?
Official Title
Secretion of Neutrophil Gelatinase Associated Lipocalin in Septic Patients and the Development of Acute Kidney Injury
Study Type
Observational
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sygehus Lillebaelt
Collaborators
Kolding Sygehus
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Sepsis, Septic Shock, Acute Kidney Injury
7. Study Design
Enrollment
21 (Actual)
Target Follow-Up Duration
5 Weeks
Primary Outcome Measure Information:
Title
Development of Acute Kidney Failure
Time Frame
During hospitalization, anticipated approximately 5 weeks
Secondary Outcome Measure Information:
Title
Levels of NGAL in patients with kidney failure compared to creatinine
Time Frame
During hospitalization, anticipated approximately 5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Study Population Description
Adults with no prior record of kidney failure
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jannie Bisgaard Stæhr, PhD, M.D
Organizational Affiliation
Odense University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Claes Falkenberg Elvander, M.D
Organizational Affiliation
Kolding Sygehus
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Srishamanthi Sriskandarajah, M.D
Organizational Affiliation
Kolding Sygehus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faelles Akut Modtagelse, Kolding Sygehus
City
Kolding
ZIP/Postal Code
6000
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Neutrophil Gelatinase Associated Lipocalin (NGAL) in Urine: Can This Prove to be a Biomarker for Acute Kidney Injury in Patients With Sepsis?
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