Acute Kidney InjuryREAL-ICUNCT01294228
Rapid Evaluation of Acute Kidney Injury With NGAL in Acutely Ill Patients in the ICU
An observational study of Acute Kidney Injury, run by Abbott RDx Cardiometabolic at 28 sites in 2 countries.
Trial summary
This is a multi-center, prospective, observational study of patients that are admitted to the intensive care unit (ICU). This study does not include any treatment or intervention and it is considered Nonsignificant Risk. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 1,001 participants
- Where
- 28 sitesin 2 countries
- Study dates
- Mar 2011to Dec 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All comers ordered to be admitted to the ICU.
Who may be able to join
- Subjects must be 21 years of age or older.
- Subjects must be admitted to an Intensive Care Unit (medical or surgical) and must be enrolled into this study within 12 hours of receipt of ICU admission orders.
- Subjects must be assessed as likely to be alive in the ICU for a minimum of 48 hours after enrollment.
- The following plasma/serum creatinine values must be available:
- Subjects that are admitted to the ICU following an elective surgery or procedure must have at least one pre-surgical/ pre-procedure creatinine value obtained in the 7 days prior to presentation to the ICU.
- Subjects that are admitted to the ICU for any reason other than following an elective surgery or procedure must have at least one creatinine value obtained greater than 7 days and up to 6 months prior to presentation to the ICU.
Who cannot join
- Subjects either receiving or in imminent need of Renal Replacement Therapy.
- Subjects with evidence of chronic kidney disease stages 4 and 5 as evidenced by a pre-enrollment estimated GFR of less than 30 mL/min/1.73M2 (according to the 4-variable MDRD22).
- Subjects with any obstructive uropathy at the time of presentation to the ICU.
- Subjects with any known urothelial, urological or kidney malignancies.
- Subjects that have had any urologic procedure or surgery immediately prior to admission to the ICU.
- Subjects that have had any renal transplant or nephrectomy.
Show all 10Show fewer
- Subjects that have had cardiovascular surgery involving cardiopulmonary bypass within the previous 7 days.
- Subjects that have participated in an interventional clinical study within the previous 30 days including studies with any investigational and non-investigational drugs.
- The inability to obtain written Informed Consent from the subject or an authorized representative.
- Subjects that have been previously enrolled in this study during a prior admission to the ICU.
Trial locations and contacts
28 sites in 2 countries.
28 sites in 2 countries
United States25 sites
University of Maryland Medical Center
Baltimore, Maryland, 21201
New York Methodist Hospital
Brooklyn, New York, 11215
Cooper University Hospital
Camden, New Jersey, 08103
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
St. Francis Sleep Allergy and Lungs
Clearwater, Florida, 33765
University Hospitals, Case Medical Center
Cleveland, Ohio, 44106
Cleveland Clinic
Cleveland, Ohio, 44195
Henry Ford Health System
Detroit, Michigan, 48202
Providence Regional Medical Center
Everett, Washington, 98201
East Carolina University
Greenville, North Carolina, 27834
Queen's Medical Center
Honolulu, Hawaii, 96813
Baylor College of Medicine
Houston, Texas, 77030
Kansas University Medical Center
Kansas City, Kansas, 66103
LA County / USC Medical Center
Los Angeles, California, 90033
International Heart Institute of Montana
Missoula, Montana, 59802
Mount Sinai Hospital
New York, New York, 10029
Cardiac and Vascular Research Center of Northern Michigan
Petoskey, Michigan, 49770
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15261
Mayo Clinic
Rochester, Minnesota, 55901
University of California, San Diego
San Diego, California, 92103
UC San Francisco General Hospital
San Francisco, California, 94110
Swedish Medical Center
Seattle, Washington, 98122
Washington University School of Medicine
St Louis, Missouri, 63110
SUNY Stony Brook University Hospital
Stony Brook, New York, 11794
Canada3 sites
Capitol District Health Authority
Halifax, Nova Scotia, B3H 1V7
Vancouver Coastal Health
Vancouver, British Columbia, V5Z 1M9
St. Boniface Hospital
Winnepeg, Manitoba, R2H 2A6
About this study
This is a multi-center, prospective, observational study of patients that are admitted to the intensive care unit (ICU). This study does not include any treatment or intervention and it is considered Nonsignificant Risk.
Read the detailed description
The study will be conducted in two phases. Phase One is specimen acquisition and subject diagnosis adjudication. Phase Two is biomarker testing.
Phase One
Approximately 850 adults admitted to general ICUs will be enrolled within 12 hours of receipt of ICU admission orders. Study specific whole blood and urine specimens will be collected.
There is an Adjudication Committee for this study. This committee is comprised of qualified, board-certified nephrologists.
Phase Two
During Phase Two, the plasma specimens will be divided amongst three clinical sites representative of the intended end users of this assay, and tested under a separate testing protocol.
- 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.
The Efficacy of the Triage Neutraphil-Gelatinase Associated Lipocalin (NGAL) Test as an Aid in the Diagnosis of Acute Kidney Injury (AKI) in an All-comers ICU Setting.
The efficacy of the Triage Neutraphil-Gelatinase Associated Lipocalin (NGAL) Test as an aid in the diagnosis of acute kidney injury (AKI) in an all-comers ICU setting. Final AKI diagnoses were established by an adjudication committee.
Measured: Prior to or within 72 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionApr 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 1,001 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott RDx Cardiometabolic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Kellum, MD, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01294228
- Sponsor's protocol ID
- BSTE-0409
- Acronym
- REAL-ICU
- Status last verified
- Dec 2016
- First submitted
- 10 Feb 2011
- Last updated
- 2 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Evaluation of Acute Kidney Injury With NGAL in Acutely Ill Patients in the ICU
- ClinicalTrials.gov ID
- NCT01294228
- Acronym / sponsor ID
- REAL-ICU / BSTE-0409
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,001 participants (actual)
- Lead sponsor
- Abbott RDx CardiometabolicUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Feb 2011 (estimated)
- Results
- Posted 2 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, prospective, observational study of patients that are admitted to the intensive care unit (ICU). This study does not include any treatment or intervention and it is considered Nonsignificant Risk.
Detailed description
The study will be conducted in two phases. Phase One is specimen acquisition and subject diagnosis adjudication. Phase Two is biomarker testing.
Phase One
Approximately 850 adults admitted to general ICUs will be enrolled within 12 hours of receipt of ICU admission orders. Study specific whole blood and urine specimens will be collected.
There is an Adjudication Committee for this study. This committee is comprised of qualified, board-certified nephrologists.
Phase Two
During Phase Two, the plasma specimens will be divided amongst three clinical sites representative of the intended end users of this assay, and tested under a separate testing protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All comers ordered to be admitted to the ICU.
Key inclusion criteria (6 listed)
- Subjects must be 21 years of age or older.
- Subjects must be admitted to an Intensive Care Unit (medical or surgical) and must be enrolled into this study within 12 hours of receipt of ICU admission orders.
- Subjects must be assessed as likely to be alive in the ICU for a minimum of 48 hours after enrollment.
- The following plasma/serum creatinine values must be available:
- Subjects that are admitted to the ICU following an elective surgery or procedure must have at least one pre-surgical/ pre-procedure creatinine value obtained in the 7 days prior to presentation to the ICU.
Key exclusion criteria (10 listed)
- Subjects either receiving or in imminent need of Renal Replacement Therapy.
- Subjects with evidence of chronic kidney disease stages 4 and 5 as evidenced by a pre-enrollment estimated GFR of less than 30 mL/min/1.73M2 (according to the 4-variable MDRD22).
- Subjects with any obstructive uropathy at the time of presentation to the ICU.
- Subjects with any known urothelial, urological or kidney malignancies.
- Subjects that have had any urologic procedure or surgery immediately prior to admission to the ICU.
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
The Efficacy of the Triage Neutraphil-Gelatinase Associated Lipocalin (NGAL) Test as an Aid in the Diagnosis of Acute Kidney Injury (AKI) in an All-comers ICU Setting.
Time frame: Prior to or within 72 hours.
The efficacy of the Triage Neutraphil-Gelatinase Associated Lipocalin (NGAL) Test as an aid in the diagnosis of acute kidney injury (AKI) in an all-comers ICU setting. Final AKI diagnoses were established by an adjudication committee.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Acute Kidney Injury, Hypotension (MeSH: D007022)
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.
John Kellum, MD principal investigator
University of Pittsburgh Medical Center
28 sites in 2 countries: 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 28 sites in 2 countries.
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 6 inclusion and 10 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 2 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Canada. 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?
Yes. Results are posted in the registry (first posted 2 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Efficacy of the Triage Neutraphil-Gelatinase Associated Lipocalin (NGAL) Test as an Aid in the Diagnosis of Acute Kidney Injury (AKI) in an All-comers ICU Setting. (time frame: Prior to or within 72 hours.). 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 2 Feb 2017.