Acute Kidney InjuryNCT00845741
Neutrophil Gelatinase-associated Lipocalin (NGAL) Evaluation in Emergency Department (ED) All-Comers
An observational study of Acute Kidney Injury, run by Abbott RDx Cardiometabolic at 1 site in Italy.
Trial summary
This study is to evaluate the NGAL point of care device as an aid in the early risk assessment of AKI (acute kidney injury)in an All-Comers ED population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 700 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2009to Aug 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: Adults presenting to the ED and designated for admission to the hospital will be enrolled.
Who may be able to join
- Males and females 18 years of age or older;
- Patients presenting to the ED who have been designated for hospital admission
- Ability to provide blood samples for baseline NGAL, Cystatin C and creatinine levels either prior to or at admission;
- Ability to provide written informed consent.
Who cannot join
- Known history of marked chronic renal insufficiency (e.g., usual serum creatinine ³ 3.0 mg/dL), on dialysis or RRT (either acute or chronic) or in imminent need of dialysis or RRT at enrollment;
- Patients with urothelial malignancies;
- Patients not expected to be admitted and therefore unable to fulfil protocol requirements for blood collection out to day 3 post admission time points
- Prisoners or other institutionalized or vulnerable individuals;
- Participation in an interventional clinical study within the previous 30 days;
- Unlikely to be willing or able to comply with study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NGAL Evaluation in ED All-Comers
This study is to evaluate the NGAL point of care device as an aid in the early risk assessment of AKI (acute kidney injury)in an All-Comers ED population.
Read the detailed description
This is a multi-center prospective pilot clinical study to assess the utility of the Triage neutrophil gelatinase-associated lipocalin (NGAL) Test as an aid in the early risk assessment for development of acute kidney injury (AKI) (sub clinical minimal changes in creatinine levels to complete failure resulting in kidney replacement therapy) in an all-comers population of patients presenting to the Emergency Department (ED) and designated for hospital admission.. The secondary objectives are to assess the utility of the Triage NGAL Test as an aid in the assessment of AKI severity in patients presenting to the ED, to determine if the combination of Triage NGAL measurements and clinical judgment can improve the early risk assessment for the development of AKI and to correlate Triage NGAL levels to patient outcomes.
Approximately 700 adults presenting to the ED and designated for admission to the hospital will be enrolled. The treating physician will note their preliminary ED diagnosis of AKI vs. no AKI (including prerenal azotemia, non-progressive chronic kidney disease (CKD) and preserved renal function) and their level of confidence in that diagnosis as a percentage following the initial exam.
EDTA anti-coagulated blood samples (for Triage NGAL Test) and blood samples for processing to serum (for Cystatin C test) will be collected and measured for NGAL and Cystatin C levels in all subjects at the following time points:
- immediately upon decision to admit to the hospital from the ED [baseline],
- at 6 and 12 hours after baseline draw
- on days 1, 2 and 3 following admission to the hospital, and
- on the day of hospital discharge (if the subject is hospitalized beyond day 3)
The results of these NGAL and Cystatin C assessments will be blinded to the medical team during the study and will not impact the medical management of the subject.
Blood samples for unblinded standard of care assessment of serum creatinine (analyzed at the hospital's laboratory) will also be obtained:
- in the ED [baseline],
- on days 1, 2 and 3 following admission to the hospital, and
- on the day of hospital discharge (if the subject is hospitalized beyond day 3)
Additional study specific blood samples for blinded assessment of serum creatinine (analyzed at the hospital's laboratory) will also be obtained:
- at 6 and 12 hours after baseline draw
- Conditions
- Acute Kidney Injury
- Medical subject headings
- Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of Acute Kidney Injury (AKI)
Measured: 0 to 48hrs after ED presentation
Secondary outcomes (1)
Assess the severity of AKI in patients using the NGAL device and clinical judgement.
Measured: 0-48hrs after ED presentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionJun 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies 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
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott RDx Cardiometabolic
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00845741
- Sponsor's protocol ID
- BSTE-0408
- Status last verified
- Oct 2010
- First submitted
- 16 Feb 2009
- Last updated
- 24 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NGAL Evaluation in ED All-Comers
- ClinicalTrials.gov ID
- NCT00845741
- Acronym / sponsor ID
- BSTE-0408
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Abbott RDx CardiometabolicUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 18 Feb 2009 (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.
This study is to evaluate the NGAL point of care device as an aid in the early risk assessment of AKI (acute kidney injury)in an All-Comers ED population.
Detailed description
This is a multi-center prospective pilot clinical study to assess the utility of the Triage neutrophil gelatinase-associated lipocalin (NGAL) Test as an aid in the early risk assessment for development of acute kidney injury (AKI) (sub clinical minimal changes in creatinine levels to complete failure resulting in kidney replacement therapy) in an all-comers population of patients presenting to the Emergency Department (ED) and designated for hospital admission.. The secondary objectives are to assess the utility of the Triage NGAL Test as an aid in the assessment of AKI severity in patients presenting to the ED, to determine if the combination of Triage NGAL measurements and clinical judgment can improve the early risk assessment for the development of AKI and to correlate Triage NGAL levels to patient outcomes.
Approximately 700 adults presenting to the ED and designated for admission to the hospital will be enrolled. The treating physician will note their preliminary ED diagnosis of AKI vs. no AKI (including prerenal azotemia, non-progressive chronic kidney disease (CKD) and preserved renal function) and their level of confidence in that diagnosis as a percentage following the initial exam.
EDTA anti-coagulated blood samples (for Triage NGAL Test) and blood samples for processing to serum (for Cystatin C test) will be collected and measured for NGAL and Cystatin C levels in all subjects at the following time points:
- immediately upon decision to admit to the hospital from the ED [baseline],
- at 6 and 12 hours after baseline draw
- on days 1, 2 and 3 following admission to the hospital, and
- on the day of hospital discharge (if the subject is hospitalized beyond day 3)
The results of these NGAL and Cystatin C assessments will be blinded to the medical team during the study and will not impact the medical management of the subject.
Blood samples for unblinded standard of care assessment of serum creatinine (analyzed at the hospital's laboratory) will also be obtained:
- in the ED [baseline],
- on days 1, 2 and 3 following admission to the hospital, and
- on the day of hospital discharge (if the subject is hospitalized beyond day 3)
Additional study specific blood samples for blinded assessment of serum creatinine (analyzed at the hospital's laboratory) will also be obtained:
- at 6 and 12 hours after baseline draw
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults presenting to the ED and designated for admission to the hospital will be enrolled.
Key inclusion criteria (4 listed)
- Males and females 18 years of age or older;
- Patients presenting to the ED who have been designated for hospital admission
- Ability to provide blood samples for baseline NGAL, Cystatin C and creatinine levels either prior to or at admission;
- Ability to provide written informed consent.
Key exclusion criteria (6 listed)
- Known history of marked chronic renal insufficiency (e.g., usual serum creatinine ³ 3.0 mg/dL), on dialysis or RRT (either acute or chronic) or in imminent need of dialysis or RRT at enrollment;
- Patients with urothelial malignancies;
- Patients not expected to be admitted and therefore unable to fulfil protocol requirements for blood collection out to day 3 post admission time points
- 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
Development of Acute Kidney Injury (AKI)
Time frame: 0 to 48hrs after ED presentation
1 secondary outcome
Assess the severity of AKI in patients using the NGAL device and clinical judgement.
Time frame: 0-48hrs after ED presentation
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 24 Jan 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Injury, run by Abbott RDx Cardiometabolic at 1 site in Italy.
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 4 inclusion and 6 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 24 Jan 2011. 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 Italy. 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 Injury (AKI) (time frame: 0 to 48hrs after ED presentation). 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 24 Jan 2011.