Severe SepsisNCT02034240
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 of Severe Sepsis and Septic Shock, run by Sygehus Lillebaelt at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Sepsis, Septic Shock, Acute Kidney Injury
- How many people
- 21 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2014to Apr 2015
- How long will I take part?
- 5 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with no prior record of kidney failure
Who may be able to join
- Severe sepsis
- Septic shock
- Patients must not be able to give consent
Who cannot join
- Underaged (18 years )
- known kidney injury
- Fully alert patients that can give consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Severe Sepsis, Septic Shock, Acute Kidney Injury
- Medical subject headings
- Sepsis, Shock, Septic, Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of Acute Kidney Failure
Measured: During hospitalization, anticipated approximately 5 weeks
Secondary outcomes (1)
Levels of NGAL in patients with kidney failure compared to creatinine
Measured: During hospitalization, anticipated approximately 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 21 participants (actual)
- Target duration
- 5 Weeks
Sponsor and investigators
- Lead sponsor
- Sygehus Lillebaelt
- Sponsor type
- University, hospital or other
- Collaborators
- Kolding Sygehus
- Responsible party
- Principal investigator, Claes Falkenberg Elvander, Sygehus Lillebaelt
- Investigators
- Jannie Bisgaard Stæhr, PhD, M.D, Study chair, Odense University HospitalClaes Falkenberg Elvander, M.D, Study director, Kolding SygehusSrishamanthi Sriskandarajah, M.D, Principal investigator, Kolding Sygehus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02034240
- Sponsor's protocol ID
- DNVK:1305 385
- Status last verified
- Apr 2015
- First submitted
- 7 Jan 2014
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secretion of Neutrophil Gelatinase Associated Lipocalin in Septic Patients and the Development of Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT02034240
- Acronym / sponsor ID
- DNVK:1305 385
- Conditions
- Severe Sepsis, Septic Shock, Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Sygehus LillebaeltUniversity, hospital or other
- Collaborators
- Kolding Sygehus
- Study start
- Jan 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 13 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Target follow-up
- 5 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with no prior record of kidney failure
Key inclusion criteria (3 listed)
- Severe sepsis
- Septic shock
- Patients must not be able to give consent
Key exclusion criteria (3 listed)
- Underaged (18 years )
- known kidney injury
- Fully alert patients that can give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of Acute Kidney Failure
Time frame: During hospitalization, anticipated approximately 5 weeks
1 secondary outcome
Levels of NGAL in patients with kidney failure compared to creatinine
Time frame: During hospitalization, anticipated approximately 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Sepsis and Septic Shock, run by Sygehus Lillebaelt at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of Acute Kidney Failure (time frame: During hospitalization, anticipated approximately 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2015.