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CompletedNCT02034240Updated Apr 21, 2015

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

An observational study in Severe Sepsis, Septic Shock and Acute Kidney Injury, sponsored by Sygehus Lillebaelt. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-21.

Sponsored by Sygehus Lillebaelt · Observational

Study type
Observational
Enrollment
21
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Severe Sepsis
  • Septic Shock
  • Acute Kidney Injury
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In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.

This study's enrollment of 21 is below the median of 160 across 931 observational studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Sygehus Lillebaelt is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

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

Enrollment
21 participants (actual)
Target follow-up
5 Weeks
Patient registry
Yes
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What researchers measure

Primary outcomes

  1. Development of Acute Kidney Failure

    Time frame: During hospitalization, anticipated approximately 5 weeks

Secondary outcomes

  1. Levels of NGAL in patients with kidney failure compared to creatinine

    Time frame: During hospitalization, anticipated approximately 5 weeks

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Study locations

1 site
  • Faelles Akut Modtagelse, Kolding Sygehus
    Kolding, 6000, Denmark
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02034240
Lead sponsor
Sygehus Lillebaelt
Collaborators
Kolding Sygehus
Responsible party
Claes Falkenberg Elvander (Medical Doctor, Sygehus Lillebaelt) — Principal investigator
First posted
Jan 13, 2014
Start date
Jan 2014
Primary completion
Apr 2015
Completion
Apr 2015
Last update
Apr 21, 2015

Study contacts

Jannie Bisgaard Stæhr, PhD, M.D
study chair · Odense University Hospital
Claes Falkenberg Elvander, M.D
study director · Kolding Sygehus
Srishamanthi Sriskandarajah, M.D
principal investigator · Kolding Sygehus

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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