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

April 19, 2015 updated by: Claes Falkenberg Elvander, Sygehus Lillebaelt

Secretion of Neutrophil Gelatinase Associated Lipocalin in Septic Patients and the Development of Acute Kidney Injury

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Kolding, Denmark, 6000
        • Faelles Akut Modtagelse, Kolding Sygehus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults with no prior record of kidney failure

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Development of Acute Kidney Failure
Time Frame: During hospitalization, anticipated approximately 5 weeks
During hospitalization, anticipated approximately 5 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Levels of NGAL in patients with kidney failure compared to creatinine
Time Frame: During hospitalization, anticipated approximately 5 weeks
During hospitalization, anticipated approximately 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sygehus Lillebaelt

Collaborators

Kolding Sygehus

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

January 7, 2014

First Submitted That Met QC Criteria

January 9, 2014

First Posted (Estimate)

January 13, 2014

Study Record Updates

Last Update Posted (Estimate)

April 21, 2015

Last Update Submitted That Met QC Criteria

April 19, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DNVK:1305 385

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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