Acute Kidney InjuryNCT01846884
Specimen Stability Study
An observational study of Acute Kidney Injury, run by Astute Medical, Inc. at 6 sites in United States.
Trial summary
To collect and process urine samples from critically ill subjects for use in assessing the effects of various urine sample freezing and storage conditions on biomarker test results. 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
- 124 participants
- Where
- 6 sitesUnited States
- Study dates
- Nov 2012to May 2013
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically-ill adult subjects at risk for acute kidney injury.
Who may be able to join
- Males and females 21 years of age or older
- Subjects must be enrolled (first study-specific sample collection) within 24 hours of ICU admission
- Subjects enrolled from ED or Floor must be admitted to the ICU within 24 hours of enrollment
- Subjects enrolled in the ICU must have been admitted to the ICU or transferred into the study ICU from another ICU no more than 24 hours prior to enrollment
- Expected to remain in the ICU for at least 48 hours after enrollment
- Use of indwelling urinary catheter as standard care expected for at least 48 hours after enrollment
- Subject (or authorized representative)able and willing to provide written informed consent for study participation
Who cannot join
- Special populations including children, pregnant women, and prisoners
- Previous renal transplantation
- Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment
- Known infection with human immunodeficiency virus (HIV) or active hepatitis (acute or chronic)
- Subjects with a history of chronic kidney disease (CKD) without a baseline serum creatinine value (baseline within 6 months of enrollment)
- Previously provided a urine sample and enrolled in this study
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Study site
Greenville, North Carolina, 27834
Study site
Honolulu, Hawaii, 96813
Study site
Idaho Falls, Idaho, 83404
Study site
La Mesa, California, 91942
Study site
Las Vegas, Nevada, 89109
Study site
Port Jefferson, New York, 11777
About this study
Official title: Urine Sample Processing Study:Analysis of Fresh Versus Frozen Urine Samples From Critically Ill Subjects
To collect and process urine samples from critically ill subjects for use in assessing the effects of various urine sample freezing and storage conditions on biomarker test results.
- 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.
Specimen handling and stability, for example, effect of temperature on biomarker results. There are no primary clinical outcomes.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2013 (estimated)
- Study startNov 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astute Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01846884
- Sponsor's protocol ID
- Opal
- Status last verified
- May 2013
- First submitted
- 29 Apr 2013
- Last updated
- 17 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Hoste EA, McCullough PA, Kashani K, Chawla LS, Joannidis M, Shaw AD, Feldkamp T, Uettwiller-Geiger DL, McCarthy P, Shi J, Walker MG, Kellum JA; Sapphire Investigators. Derivation and validation of cutoffs for clinical use of cell cycle arrest biomarkers. Nephrol Dial Transplant. 2014 Nov;29(11):2054-61. doi: 10.1093/ndt/gfu292. Epub 2014 Sep 18.
PubMed 25237065
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urine Sample Processing Study:Analysis of Fresh Versus Frozen Urine Samples From Critically Ill Subjects
- ClinicalTrials.gov ID
- NCT01846884
- Acronym / sponsor ID
- Opal
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Astute Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 6 May 2013 (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.
To collect and process urine samples from critically ill subjects for use in assessing the effects of various urine sample freezing and storage conditions on biomarker test results.
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
- Critically-ill adult subjects at risk for acute kidney injury.
Key inclusion criteria (7 listed)
- Males and females 21 years of age or older
- Subjects must be enrolled (first study-specific sample collection) within 24 hours of ICU admission
- Expected to remain in the ICU for at least 48 hours after enrollment
- Use of indwelling urinary catheter as standard care expected for at least 48 hours after enrollment
- Subject (or authorized representative)able and willing to provide written informed consent for study participation
Key exclusion criteria (6 listed)
- Special populations including children, pregnant women, and prisoners
- Previous renal transplantation
- Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment
- Known infection with human immunodeficiency virus (HIV) or active hepatitis (acute or chronic)
- Subjects with a history of chronic kidney disease (CKD) without a baseline serum creatinine value (baseline within 6 months of enrollment)
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
Specimen handling and stability, for example, effect of temperature on biomarker results. There are no primary clinical outcomes.
Time frame: 6 months
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 17 May 2013.
- Derived from this study: PubMed 25237065Hoste EA, McCullough PA, Kashani K, Chawla LS, Joannidis M, Shaw AD, Feldkamp T, Uettwiller-Geiger DL, McCarthy P, Shi J, Walker MG, Kellum JA; Sapphire Investigators. Derivation and validation of cutoffs for clinical use of cell cycle arrest biomarkers. Nephrol Dial Transplant. 2014 Nov;29(11):2054-61. doi: 10.1093/ndt/gfu292. Epub 2014 Sep 18.
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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.
6 sites 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 Astute Medical, Inc. at 6 sites in United States.
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 7 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 17 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
Specimen handling and stability, for example, effect of temperature on biomarker results. There are no primary clinical outcomes. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01846884, which also lists 1 linked publication.
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 17 May 2013.