Acute Kidney FailureNESAKINCT01122225
Neutrophile Gelatinase Associated Lipocalin Evaluation in Septic Acute Kidney Injury
An observational study of Acute Kidney Failure, run by Université Victor Segalen Bordeaux 2 at 1 site in France.
Trial summary
Acute kidney injury (AKI) is a major organ failure in septic shock. Current medical tests (serum creatinine and urea) cannot identify AKI until approximately 48 hours after it occurs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Failure
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2009to Jun 2010
- 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: patients of a medical intensive care presenting with a septic shock
Who may be able to join
- Patients showing signs of infection and hypotension requiring the use of epinephrine despite of an appropriate fluid challenge.
- 18 years of age or older
Who cannot join
- Age under 18 years
- Prisoners or other institutionalized or vulnerable individuals
- Participation in an interventional clinical study within the previous 30 days
Trial locations and contacts
1 site in 1 country.
France1 site
Reanimation medicale, Hopital Saint-Andre, Bordeaux University Hospital
Bordeaux, Aquitaine, 33000
About this study
Acute kidney injury (AKI) is a major organ failure in septic shock. Current medical tests (serum creatinine and urea) cannot identify AKI until approximately 48 hours after it occurs. Neutrophil gelatinase-associated lipocalin (NGAL) may be able to predict ischemic AKI more effectively and faster than serum creatinine and urea levels.
The purpose of this study is to take a blood sample from patients at admission and then at 24 and 48 hours after to test their plasma for NGAL and compare the NGAL levels to their creatinine and urea levels. The investigators hypothesize that NGAL is an earlier marker to classify the kidney failure as acute tubular necrosis or pre-renal azotemia than creatinine and urea.
Read the detailed description
Primary Outcome Measures:
To correlate elevated serum NGAL with the diagnosis of intrinsic acute kidney injury in septic shock
Secondary Outcome Measures :
To compare serum NGAL with serum creatinine, serum urea and urine output in septic AKI Death within the intensive care unit Death from all causes at 28 days after inclusion
- Conditions
- Acute Kidney Failure
- Keywords
- septic shock, medical intensive care
- Medical subject headings
- Acute Kidney Injury, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Septic shock | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2010 (estimated)
- Study startJul 2009
- Primary completionMay 2010
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney FailureStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Victor Segalen Bordeaux 2
- Sponsor type
- University, hospital or other
- Collaborators
- Inverness Medical Innovations
- Investigators
- Fabrice Camou, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01122225
- Sponsor's protocol ID
- NESAKI08-267
- Acronym
- NESAKI
- Status last verified
- Apr 2010
- First submitted
- 10 May 2010
- Last updated
- 31 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neutrophile Gelatinase Associated Lipocalin Evaluation in Septic Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT01122225
- Acronym / sponsor ID
- NESAKI / NESAKI08-267
- Conditions
- Acute Kidney Failure
- Keywords
- septic shock, medical intensive care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Université Victor Segalen Bordeaux 2University, hospital or other
- Collaborators
- Inverness Medical Innovations
- Study start
- Jul 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2010 (estimated)
- First posted
- 13 May 2010 (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.
Acute kidney injury (AKI) is a major organ failure in septic shock. Current medical tests (serum creatinine and urea) cannot identify AKI until approximately 48 hours after it occurs. Neutrophil gelatinase-associated lipocalin (NGAL) may be able to predict ischemic AKI more effectively and faster than serum creatinine and urea levels.
The purpose of this study is to take a blood sample from patients at admission and then at 24 and 48 hours after to test their plasma for NGAL and compare the NGAL levels to their creatinine and urea levels. The investigators hypothesize that NGAL is an earlier marker to classify the kidney failure as acute tubular necrosis or pre-renal azotemia than creatinine and urea.
Detailed description
Primary Outcome Measures:
To correlate elevated serum NGAL with the diagnosis of intrinsic acute kidney injury in septic shock
Secondary Outcome Measures :
To compare serum NGAL with serum creatinine, serum urea and urine output in septic AKI Death within the intensive care unit Death from all causes at 28 days after inclusion
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Septic shock | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients of a medical intensive care presenting with a septic shock
Key inclusion criteria (2 listed)
- Patients showing signs of infection and hypotension requiring the use of epinephrine despite of an appropriate fluid challenge.
- 18 years of age or older
Key exclusion criteria (3 listed)
- Age under 18 years
- Prisoners or other institutionalized or vulnerable individuals
- Participation in an interventional clinical study within the previous 30 days
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2010.
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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.
Fabrice Camou, MD principal investigator
University Hospital, Bordeaux
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 Acute Kidney Failure, run by Université Victor Segalen Bordeaux 2 at 1 site in France.
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 2 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: status not confirmed, as of the sponsor's last update on 31 May 2010. 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 France. 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?
Results are not available in the source record.
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.
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 31 May 2010.