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

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02034240
• Other study ID #: DNVK:1305 385
• Status: Completed
• Phase: N/A
• First received: January 7, 2014
• Last updated: April 19, 2015
• Start date: January 2014
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Sygehus Lillebaelt
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Acute Kidney Injury
• Septic Shock
• Severe Sepsis

Locations

Country	Name	City	State
Denmark	Faelles Akut Modtagelse, Kolding Sygehus	Kolding

Sponsors (2)

Lead Sponsor	Collaborator
Sygehus Lillebaelt	Kolding Sygehus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of Acute Kidney Failure		During hospitalization, anticipated approximately 5 weeks	No
Secondary	Levels of NGAL in patients with kidney failure compared to creatinine		During hospitalization, anticipated approximately 5 weeks	No