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

NCT02034240 | Completed DMC

• 1 other identifier: DNVK:1305 385
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Sepsis; Septic Shock; Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Development of Acute Kidney Failure

  During hospitalization, anticipated approximately 5 weeks

Secondary Outcomes (1)

• Levels of NGAL in patients with kidney failure compared to creatinine

  During hospitalization, anticipated approximately 5 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with no prior record of kidney failure

You may qualify if:

• Severe sepsis
• Septic shock
• Patients must not be able to give consent

You may not qualify if:

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

Sponsors & Collaborators

• Sygehus Lillebaelt: lead
• Kolding Sygehus: collaborator

Study Sites (1)

Faelles Akut Modtagelse, Kolding Sygehus

Kolding, 6000, Denmark

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Jannie Bisgaard Stæhr, PhD, M.D

  Odense University Hospital

  STUDY CHAIR

• Claes Falkenberg Elvander, M.D

  Kolding Sygehus

  STUDY DIRECTOR

• Srishamanthi Sriskandarajah, M.D

  Kolding Sygehus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Target Duration: 5 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: January 7, 2014
• First Posted: January 13, 2014
• Study Start: January 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: April 21, 2015

Record last verified: 2015-04

Locations

DK (1)